Category Archives: Food Supplements

Portland, Oregon--(Newsfile Corp. - May 17, 2023) - HTO - Nevada, dba. Kirkman, a subsidiary of Hemptown Organics Corp. ("Hemptown" or the "Company") has been recognized as one of the 50 most admired companies to watch in 2023, as identified by CIO Bulletin.

Kirkman is an industry leader in the manufacturing of nutritional supplements. The company has been in business since 1949. It offers the purest, most up-to-date, and highest-quality dietary supplements for children, adults, and people with dietary sensitivities and special requirements. It works with leading researchers, doctors, and scientists to develop these products with the best balance of nutrients in dosages that are easy to administer. The majority of its products are hypoallergenic (free of additives like colorings and flavorings, to which many consumers are sensitive) and free of the FDA's nine major food allergens (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soy, and sesame).

Eric Gripentrog, CEO of Kirkman, spoke exclusively to the CIO bulletin about how his company manufactures their high-quality nutritional supplements for everyone.

"Nearly every supplement we produce is hypoallergenic and designed for people with dietary sensitivities. For this reason, almost all our supplements are free of artificial colors, flavors, and sweeteners."

CIO Bulletin Interview Highlights

Q. Why was the company established? And how did the idea of manufacturing nutritional supplements occur back in the 1940s?

The idea of the "vitamin pill" became a reality in the early 20th century. It was in the 1940s when these supplements became available at a fraction of the cost that they were only a few years earlier. This was the beginning of Kirkman as it is known today.

Lyle Wellman and Bill Graham founded Kirkman Labs (now Kirkman) in 1949 in Seattle, Washington. In 1967, it was sold to Stan Bachman, who relocated the company to Portland, Oregon. It was in the late 1960s when Kirkman was recognized as a trailblazer of supplements for a particular group of people with dietary sensitivities with Super Nu-Thera.

Story continues

Q. Can your company make supplements without unnecessary excipients?

Our supplements are hypoallergenic and designed for people with dietary sensitivities. For this reason, almost all our supplements are free of artificial colors, flavors, and sweeteners. We subscribe to using natural colorings and flavorings wherever possible, many derived from fruits and vegetables, like blueberry, raspberry, and mango. All our plant-based capsules are gelatin-free (made from Hypromellose), making many of our supplements available for consumption by vegetarians and vegans.

Q. Do you stay on top of the ever-changing supplement industry trends?

We watch the trends and try to tailor our products to fit current demand. Because we design so many of our products for diet-sensitive people, we endeavor to create products that are suitable for the general market as well as those that might have issues taking the "latest trend in supplements."

One such example is our new line of mushroom-based products. We have taken elements from these incredible sources and created three new formulations addressing Gut Health, Energy & Endurance, and Mental Clarity & Focus. And with the surge of sleep aids hitting the market (the vast majority containing melatonin), we created an Herbal Sleep Aid made from natural sources that have been shown to be effective for centuries. This blend is melatonin-free, so people who have issues with melatonin can take it.

Q. How do you stay ahead of the competition in a market flooded with nutritional supplement manufacturers?

We cannot address our success without mentioning our loyal customer base. Having designed so many effective products addressing specific diets from early childhood to adulthood, we have literally "raised many individuals from childhood to adulthood." The reason that these loyal customers stay with us for so long is that they have experienced the proven benefits of Kirkman's clean, pure, bioavailable, and allergen-free supplements.

Kirkman is specifically known for its line of probiotics that rate higher than most others for containing effective live cultures, whereas many other over-the-counter probiotic supplements only sustain a small percentage of these living cultures from the factory to the store shelf. When it comes down to it, delivering proven, Ultra Tested products to a health-conscious community helps keep us ahead of the curve. Though developed for diet-sensitive people, it quickly became evident that everyone could benefit from Kirkman's easily absorbed, bioavailable supplements.

Q. How have you been helping people living with dietary sensitivities?

Bernard Rimland, a world-renowned innovator and doctor to those on the autism spectrum, approached Kirkman in the 1960s. He addressed many dietary issues that his patients were experiencing with allergens, absorption, and other issues. We created Super Nu-Thera, a multivitamin that comes in a variety of delivery mediums and flavors, making it easier to administer to children. Along with Super Nu-Thera, we developed a number of other vitamins, minerals, probiotics, amino acids, and so on that proved to be particularly effective for those on the spectrum. Almost all of these supplements were free of the top nine allergens outlined by the FDA (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soy, and sesame), to which many of his patients were sensitive.

Our collaboration with Dr. Rimland put us on a new path to collaborate with doctors, researchers, and pharmacists from all over the world to design products that meet the specific needs of these professional advisors and our customers. As the news spread, doctors within these communities, all over the globe, began recommending Kirkman supplements to their patients. Over the past five decades, we have developed more than 400 formulations of supplements-multivitamins, digestive health, and in many dietary and behavioral health categories.

Q. With 70 years of working as the manufacturer of nutritional supplements, you must have encountered some major ups and downs. How have the challenges helped you reach success?

One of the largest challenges Kirkman has faced was the cessation of production of raw materials, the slowing of shipping channels, and the hurdles of obtaining product during the COVID-19 pandemic. At its onset, worldwide manufacturing of many raw materials simply stopped. With nearly the entire world "on-hold," shipping any available products became a slow and increasingly expensive task. Dibs on the limited available product were given to the large corporate manufacturers over the smaller companies, which Kirkman was. A large problem for Kirkman was obtaining the superior grade of cultures to make our line of probiotics, which amounts to approximately 15% of the company's total sales.

Kirkman has a very strict basis for obtaining its high-grade, superior, clean, and pure raw materials from trusted sources. Because of its integrity and promise to its customers, Kirkman was left with very few alternative sources. Also, the cost of these raw materials increased by as much as 400%-500%, not to mention the skyrocketing shipping and import costs. Nevertheless, Kirkman did not raise its prices to consumers during the first year and a half of the pandemic, sticking to prices set nearly five years before the outbreak.

To be fair, Kirkman began to "ration" it's available products to its business-to-business and direct-to-consumer customers. Our sales team did an incredible job of delivering products fairly and "as needed" to all its customers and did not deliver only when delivery was impossible. It is partially because of this integrity, fair distribution, and concern for its customers that Kirkman's customer base remained loyal throughout this trying time.

Take us through the technology or "difference makers" that enabled Kirkman to exist.

Kirkman prides itself on providing the cleanest and purest supplements on the market. With our registered trademark Ultra Tested, we have a proprietary testing protocol that exceeds the FDA requirements to ensure we deliver the most efficacious and purest supplements on the planet. Our brand is built on the execution of testing protocols for the lowest detectable limits of heavy metals and contaminants. Executing hundreds of Standard Operating Procedures (SOPs) in our facility is essential for strict compliance with these testing measures. Whether the product is delivered in the form of a capsule, tablet, liquid, powder, or cream, we guarantee that it is 100% pure.

What makes Kirkman different from other manufacturers is the 'bar' for quality. Not only do we validate all our vendors; materials, components, and suppliers; we continually check quality throughout the manufacturing process. Materials and components are checked and inspected upon receipt for physical damage and checked for potency and contamination during inspection. In-process checks are performed a minimum of three times per hour to ensure the quality is verified and maintained. A single product is quality checked up to 15 times during its production cycle.

About Hemptown Organics Corp.Hemptown is a diversified, industry-leading, nutraceutical company delivering a diverse product offering across the value chain, in multiple sales channels, to meet the growing global demand for consumer goods products. Starting with a strong leadership team with Fortune 500 experience and with an FDA-registered and cGMP certified product manufacturing facility, Hemptown continues to innovate as the Company continues to press forward into the consumer-packaged good sector with top quality, white label, and branded product lines for the consumer market. For more information, visit http://www.hemptownusa.com or http://www.hemptownnaturals.com.

Hemptown Investor Relationsinfo@hemptownusa.com1-833-436-7896

Hemptown Sales and General InquiriesScott@hemptownusa.com1-888-CBG-NOW1 (1-888-224-6691)

Disclaimer for Forward-Looking Statements

This news release contains forward-looking statements that involve various risks and uncertainties regarding future events. Such forward-looking statements are based on current expectations of management, involve a number of risks and uncertainties, and are not guarantees of future performance. These statements generally can be identified by the use of forward-looking words such as "may", "should", "will", "could", "intend", "estimate", "plan", "anticipate", "expect", "believe" or "continue", or the negative thereof or similar variations. Forward-looking statements in this news release include statements regarding the anticipated flavors of the Hemp Naturals line, the anticipated size and growth of the smokable hemp industry and hemp-derived CBD consumer products industry the Company's goal of having its hemp cigarette 20-packs in every convenience store and gas station counter in America, and the timing of the rollout of the Company's products into retail stores. Forward-looking statements are necessarily based on a number of estimates and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors that may cause actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include general market conditions, significant business, competitive, political, and social risks, governmental regulations being implemented regarding the production and sale of products containing hemp/CBD, and other factors beyond the control of the Company. The Company expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, future events, or otherwise, except as required by applicable law.

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/166503

Read more here:

Hemptown's Kirkman Subsidiary Named One of the 50 Most Admired Companies to Watch in 2023 - Yahoo Finance

Delaney Nothaft| Special to USA TODAY

You may have heard of biotin in regard to potential ways to strengthen your hair and nails. And it does! But it is also responsible for so much more like aiding in the breakdown of food.

We spoke with Kelly Morrow, MS, RDN, FAND, a registered dietitian and clinical affiliate of the Osher Center for Integrative Medicine at the University of Washington, and Clara Di Vincenzo, RD, LD, a registered dietitian for the Digestive Health Institute at UT Health Austin. They told us everything you need to know biotin, including information about supplements and which foods are rich in biotin.

Di Vincenzo says, Biotin is known to be essential in the strengthening of hair and nails. Morrow says that this is because Biotin is important for gene expression and the growth of new cells.

But it is also a B-vitamin that helps us metabolize or break down the food that we eat into carbohydrates, fats and proteins, which are the building blocks that help us with body processes, Di Vincenzo emphasizes.

Morrow adds, It helps keep blood sugar balanced by helping the liver to release glucose into the blood when we have gone for a long time between meals.

Di Vincenzo says, We can get adequate amounts of biotin from the food that we eat and from bacteria in our large intestine. Most people do not need a supplement. Its water soluble, so an excess amount would get excreted in the urine.

However, a biotin deficiency is possible. Both Morrow and Di Vincenzo describe some of the warning signs as:

Di Vincenzo recommends that if you have symptoms of biotin deficiency, you should follow up with your doctor and get regular blood work and evaluate for deficiency before jumping to a supplement. Food is our primary source of fuel, Di Vincenzo emphasizes. More often than not we can find the nutrients we need in foods themselves rather than supplementation, she adds.

Biotin is actually produced by bacteria in your gut, which is one source of the biotin you need. Foods that are high in biotin include:

In conclusion: supplementation with biotin supplements is generally safe, but it may not be as effective as having a balanced, nutritional diet. And if you are concerned about a biotin deficiency, you may want to have a conversation with your doctor or add biotin-rich foods to your diet, like eggs. Or beans. Or, my southwest favorite an omelet filled with beans.

More about supplements: What are dietary supplements and how can they lead to better health?

Report suggests: Take vitamins and supplements? You may be wasting your money on them.

The experts: Do collagen supplements work?

More: Everyone is talking about biotin supplements. Here's what you need to know.

Original post:

What is biotin? Foods to eat and if you should take it every day - USA TODAY

With summer creeping in, people will be looking to get out a little more and make the most of good weather while it's here.

However, it may be worth considering what vitamins you're taking, as with more sunlight, you might not need quite as much vitamin D supplementation. And likewise, you may want to bump up the number of vitamins you're taking elsewhere, such as Vitamin C which can help shield you from pollutants in the outside air.

With that in mind, Public Health Nutritionist Dr Emma Derbyshire from the Health & Food Supplements Information Service (HSIS) has named some vitamins we should prioritise.

According to the expert, these four vitamin groups may be worth taking as summer weather continues to creep in.

You may be getting more sunlight now but it is still important to maintain good levels of vitamin D.

"Levels of vitamin D will be low at the end of the winter and moving into spring," says the Public Health Nutritionist. Dr Emma Derbyshire from the Health & Food Supplements Information Service (HSIS).

"Vitamin D is important for the absorption of calcium and healthy bones and teeth as well as for immune function.

"The UK government recommends that we all take a 10 microgram daily supplement throughout the year but especially in winter through to spring."

Similarly, Vitamin C is important as you will be spending more time outside with more exposure to the outside air.

"Vitamin C protects cells from the oxidative damage caused by pollutants. [It] also helps with the absorption of iron," says the expert. "Many women are short of iron particularly during their reproductive years so boosting vitamin C intake helps to reduce the risk of iron deficiency and the tiredness and fatigues that can cause."

You can find it in citrus fruits, tomatoes and peppers as well as multivitamin and multimineral supplements

B vitamins include thiamin (vitamin B1), riboflavin (vitamin B2) and vitamin B6, niacin (vitamin B3), pantothenic acid, vitamin B6 (also known as pyridoxine) and biotin (vitamin B7).

And though it is a B vitamin, it is important to look at vitamin B12 independently, says Derbyshire, as it impacts so many different aspects of our health.

"Vitamin B12 is essential for several issues we need help with in the spring from immune function to tiredness and fatigue.

"Spring is also a time when you might decide to cut back on the stodgier foods of winter. You might opt for a plant-rich diet which is healthy but if you cut out meat and other animal-source foods you are at risk of vitamin B12 deficiency."

"Folate is vital for immune function which may have taken a battering by springtime. Its also important for reducing tiredness and fatigue, says Derbyshire.

"Top up your levels by eating kale, broccoli, spinach, chickpeas and a supplement containing folic acid."

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Excerpt from:

Best vitamins to be taking as seasons change, according to health expert - Daily Record

NEWS RELEASE

JEFFERSON PARISH, LOUISIANA

May 17, 2023FOR IMMEDIATE RELEASE

KITTEN YOGA RETURNS TO EAST BANK REGIONAL LIBRARY

JEFFERSON, LA Kitten Yoga, a playful class in which patrons work through a yoga class while kittens scamper around the room, will occur again this June and July at the East Bank Regional Library, 4747 W. Napoleon Ave., Metairie.

This event is free of charge and open to the public. There is no registration. This event is open to patrons 12 years of age and older.

Cats and kittens from Jefferson Protection & Animal Welfare Services (JPAWS) will be on-site to meet and greet, play with and be available for adoption.

Classes will occur at the following times and dates.

Supplies to help JPAWS will be accepted. In-need items include: Royal Canin Mother and Baby Cat Wet and Dry Food, Royal Canin Kitten Wet and Dry Food, Fancy Feast Kitten Wet Food, 1ml syringes without needles, kitten milk replacement, kitten bowls, towels, hand sanitizer, Tidy Cats clay litter, dog and cat toys, Dawn dish soap, cat treats, Tiki Cat Baby and Thrive food/supplements, and gift cards to Amazon, Jefferson Feed, Petco, PetSmart and Walmart.

For more information regarding this event, contact Chris Smith, Manager of Adult Programming for the library, at 504-889-8143 or wcsmith@jefferson.lib.la.us.

For more information about Jefferson Parish, visit http://www.JeffParish.net Residents can also receive regular updates by following the Parish on Facebook, Twitter and Instagram (@JeffParishGov) or by texting JPALERT or JPNOTICIAS to 888-777.

###

Jefferson Parish Public Information Office

1221 Elmwood Park Boulevard, Suite 1002

Jefferson, LA 70123

JPALERT SIGN UP TO RECEIVE EMERGENCY ALERTS

Gretchen Hirt Gendron, PIO

Originally posted here:

KITTEN YOGA RETURNS TO EAST BANK REGIONAL LIBRARY ... - Jefferson Parish

There are two main types of fiber: soluble and insoluble, and both types are recommend for optimal health. According to Cabrero, it is important to note that most plant-based foods have a combination of both types of fiber, and depending on the condition you want to treat, you may want to highlight one over the other.

Soluble fiber: As the name implies, this type of fiber dissolves in water. "It acts like a sponge and can help bulk up your stool, softening it and making it easier to pass," Cabrero says. "Many soluble fibers are also fermentable fibers," and can help to create a healthy gut microbiome because "they are the food of choice for beneficial bacteria." It is associated with slowing digestion time, can help you feel fuller longer and may aid in weight management. It is also associated with a decreased risk of heart disease, improved blood sugar control and decreased cholesterol levels.

Insoluble fiber: This type of fiber does not dissolve in water but it works to bulk your stool and it can help promote regular bowel movements and prevent constipation. It is often found in plant foods that seem rough or stringy, or have a tough skin, hull, peel, pod or seeds. For this reason, insoluble fiber is often referred to as roughage, according to Cabrero. "Insoluble fiber can help regulate bowel movements by creating mechanical stimulation and triggering motility," she adds.

Food sources of fiber: Most plant foods contain a combination of both soluble and insoluble fiber and the best way to get fiber in your diet is to eat a diet diverse in fruits and vegetables. "Eat what you like and what feels more comfortable to your gut and your palate," Cabrero says. If fiber-rich foods tend to contribute to gas or bloating, Cabrero recommends "sometimes modifying textures such as cooking, blending or finely chopping, [which] can help the digestibility." Examples of foods that are a rich source of fiber include:

Excerpt from:

8 Best Fiber Supplements of 2023, Tested by Experts - Good Housekeeping

While the state of the U.S. Food and Drug Administrations (FDAs) regulation of Cannabidiol (CBD) remains gray, the agency now sees a path forward through federal legislation. Heres what companies in the cannabis industry need to know:

The FDA is looking to provide a new regulatory pathway for CBD, while still committing to its enforcement of unlawful CBD marketing and sales. On January 26, 2023, the FDAissueda statement acknowledging that a new regulatory pathway for CBD is neededone that balances access to CBD products with regulatory oversight. The statement included the FDAs denial of three citizen petitions that asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements. The FDAs existing authorities provide limited tools for managing many of the risks associated with CBD products, andaccording to the FDAit is not apparent how CBD products could meet safety standards for dietary supplements or food additives under the Food, Drug, and Cosmetic Act (FD&C Act). In the statement, the FDA says it is looking to Congress to develop a cross-agency strategy for the regulation of these products to protect the publics health and safety.

The FDAs recent move to shift the responsibility of CBD regulation to Congress is just the latest instance in a longstanding game of regulatory hot potato. On April 17, 2023, the Chair of the House Oversight and Accountability Committee sent aletterto the FDA Commissioner, announcing an investigation into the FDAs decision to not engage rulemaking for CBD and criticized the insufficient rationale for inaction on CBD regulations.

Current Regulation of CBDTwo Steps Forward, Three Steps Back

2018 Farm Bill

All hemp is cannabis, but not all cannabis is hemp. CBD is the second most prevalent active ingredient in cannabis (behind THC), and while it is an essential component of marijuana, it can also be derived from the hemp plant. Three hemp derivatives (hemp seed oil, hemp seed protein powder, and hulled hemp seedalso known as hemp hearts) were firstgenerally recognized as safe (GRAS)food ingredients in 2018 by the FDA. Up until April 2018, all CBD was considered a Schedule 1 substance under the Controlled Substances Act (CSA) because it is a chemical component of the cannabis plant. However, the2018 U.S. Farm Billremoved hemp-derived CBD with very low levels of THC (0.3 percent or less) from the definition of marijuana in the CSA. Over the past five years, industry stakeholders have advocated for regulation of the gray area of CBD outside that limited definition of the Farm Billspecifically, regulation of cannabis-derived CBD and of hemp-derived CBD with levels of THC over 0.3 percent.

The 2018 Farm Bill explicitly preserved the FDAs authorities over hemp products, including hemp-derived CBD, meaning that hemp products must meet any applicable FDA requirements and standards, just like any other FDA-regulated product. For example, the FDAs existing authorities over foods, dietary supplements, human and animal drugs, and cosmetics apply to hemp products to the extent such hemp products fall within those categories. These products include food or beverage products labeled as containing CBD that you may see at your local grocery store. However, aside from the three GRAS hemp ingredients, the FDA has not approved any CBD ingredients for food and beverage products.

By the FDAs own admission, the FDAs existing authorities provide limited tools for managing many of the risks associated with CBD products, and it is not apparent how CBD products could meet safety standards for dietary supplements or food additives under the FD&C Act, as discussed more below. The FDA has stated that, because CBD is outside of the statutory definition of a dietary supplement, it is unlawful under the FD&C Act to introduce into interstate commerce a food (including any animal food or feed) to which CBD (an unregulated substance) has been added. This rule limits makers of food and beverage products containing cannabis-derived CBD or hemp-derived CBD with any levels of THC from shipping their products online, even if they are selling their products in states where CBD is legal.

Pathways to Regulation of CBD

The FDA has interpreted two similar provisions in the FD&C Act prohibiting marketing of hemp-derived CBD known as the exclusionary clauses: one for foods (FD&C Act 301(ll)) and one for dietary supplements (FD&C Act 321(ff)(3)(B)). The exclusionary clause for dietary supplements states that the dietary supplements do not include an article that was either approved as a new drug, antibiotic, or biologic, or authorized for investigation as a drug, antibiotic, or biological for which substantial clinical investigations have been instituted and made public.

However, a dietary supplement that would otherwise be excluded can be exempted if the Secretary of Health and Human Services (HHS) issues a regulation (following the notice and comment process) finding the article would be lawful for use as a food or dietary supplement. But the FDA has held firm that this is not a possible route for CBD regulation because it has previously been investigated as a new drug. The FDA points to the June 2018 approval of CBD-based drugEpidiolex, which treats seizures associated with two very rare and severe pediatric epileptic syndromes.

Since 2019, three industry trade organizations have filed citizen petitions with the FDA, each addressing longstanding industry desires to the use of CBD in dietary supplements, conventional foods, and animal food. The petitions, submitted byConsumer Healthcare Products Association,Council for Responsible Nutrition(CRN), andNatural Products Association, propose that the FDA require manufacturers of dietary supplements containing CBD to submit a new dietary ingredient notification for CBD and use appropriate labeling and claimsas opposed to using drug claims. Alternatively, the organizations propose, the FDA can clarify the definition of article for purposes of the exclusionary clause. For example, CRN asserted that hemp extracts that contain CBD should not be classified as the same article when Epidiolex involved a 99 percent pure CBD, while many commercially available hemp extract contain numerous cannabinoids other than CBD, flavonoids, terpenes, and other phytochemicals. Lastly, the organizations ask that the Secretary of HHS engage in the notice and comment process, issuing a final rule legalizing CBD.

The FDAs Desire to Find a Path ForwardJust Not Through Them

On January 26, 2023, the FDAissueda statement acknowledging that, while a new regulatory pathway for CBD is needed that balances access to CBD products with regulatory oversight, it would not be doing so through rulemaking. The statement also announced the FDAs denial of the three citizen petitions asking the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.

The FDA continued in its statement that CBD raises various safety concerns with long-term use, and a new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products.

The statement notes that a high-level internal working group, chaired by Principal Deputy CommissionerJanet Woodcock, has closely examined studies related to the CBD-based drugEpidiolex. Commissioner Woodcock stated: Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm.

The FDAs concern is not without basisin a recent studypublished on April 25, 2023, in JAMA, researchers found that one of the 25 products labeled as melatonin gummies tested contained no melatonin at allit was just CBD.

Instead of pursuing rulemaking allowing the use of CBD in dietary supplements, conventional foods, or animal food, the FDA said it is looking to collaborate with Congress. The FDA said it looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the publics health and safety.

Havent We Been Here Before?

Yesa few times. In 2021, bipartisan groups in both the House and Senate introduced bills that would address the regulatory gap for hemp-derived CBD. In May 2021, a bipartisan group of senators introduced the Hemp Access and Consumer Safety Act, and in December 2021, a bipartisan group of representatives introduced the CBD Product Safety and Standardization Act. Both bills, which would require the FDA to develop regulations for food and beverages containing hemp-derived CBD and allow for their interstate commerce, only made it as far as referrals to their respective health committees in 2021.

On March 17, 2023, theCBD Product Safety and Standardization Act(HR 1628) was reintroduced in the House along with a new siblingtheHemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023(HR 1629). The former proposes to authorize the regulation of interstate commerce with respect to food containing cannabidiol derived from hemp, and for other purposes; the latter proposes to make hemp, cannabidiol derived from hemp, and any other ingredient derived from hemp lawful for use under the [FD&C] Act as a dietary ingredient in a dietary supplement, and for other purposes. The new bills would direct the FDA to issue regulations establishing a maximum allowable amount of CBD per serving, labeling and packaging requirements, and conditions of intended use.

On April 17, 2023, the Chair of the House Oversight and Accountability Committee, Representative James Comer (R-KY) sent aletterto the FDA Commissionerin direct response to the FDAs January statementannouncing an investigation into the FDAs decision to not engage rulemaking for CBD. Representative Comer wrote that the agencys argument that theres not a regulatory pathway to enact CBD regulations is an insufficient rationale for inaction that is directly affecting the welfare of the American public. Representative Comer listed documents and information for the FDA to provide to the committee by May 1, 2023:

The FDA has not yet responded to the request.

Next Steps for Manufacturers

Manufacturers of hemp-derived CBD products will need to closely monitor the FDAs and Congresss pathway for CBD and be careful to not violate the FD&C Act in the interim. The FDA said in the January 26th statement that it will continue its enforcement actions against CBD and other cannabis-derived products to protect the public.

James Ravitz and Marissa Hill Daleycontributed to the preparation of this Wilson Sonsini Alert.

Go here to see the original:

FDA Passes the Buck (Back) to Congress for Legislative Solution on ... - JD Supra

Christy Harrison is a journalist and registered dietitian specializing in disordered-eating recovery. certified intuitive eating counselor, and journalist who writes about food and nutrition. She is the founder and host of the Food Psych podcast. Her writing has appeared in the New York Times, SELF, BuzzFeed, WIRED, Refinery29, Slate, and The Food Network.

Below, Christy shares 5 key insights from her new book, The Wellness Trap: Break Free from Diet Culture, Disinformation, and Dubious Diagnoses, and Find Your True Well-Being. Listen to the audio versionread by Christy herselfin the Next Big Idea App.

Theres a common belief in wellness culture that being well means eating almost nothing but vegetables and proteinand of course, being thin. Many influencers and alternative- or integrative-medicine providers advocate cutting out a staggering array of foodsgluten, dairy, grains, anything processed, even certain vegetablesfor supposed wellness.

But these restrictions often make people fear food and can lead to disordered eating habits. Cutting out food groups, limiting eating to small windows of the day rather than eating when youre hungry, or otherwise overhauling your menu is a big deal for most people. Such a radical switch in diet can be a major life change that can affect your relationships and interfere with your ability to take pleasure or find spontaneity in food. There are serious side effects to dietary changes. When youre following wellness cultures diet rules, they can often start to take over your life.

This includes a woman named Erin, who has struggled with psoriasis and several other chronic conditions for many years. She started working with an alternative-medicine provider, who told her she was intolerant of sugar, dairy, and vegetables and fruits from the nightshade family, among many other foods. She started to see food as dangerous, and her diet became extremely limited. She cut out sugar completely for a few years, to the point where she was even making her own ketchup from scratch. She also was prescribed a long list of supplements and other treatments. At one point, she was taking at least twenty different supplements a day. Not only did she develop an eating disorder as a result of all this restriction, but her psoriasis didnt improve at all; in fact, it got worse.

Diets like the one Erin was on generally dont have good scientific evidence behind them. Even if they did, its incredibly difficult to stay on those diets long-term without damaging your relationship with food and your mental, emotional, and social well-being. If a way of eating detracts from those aspects of your life, can it even really be called wellness?

Like too many people, Erin had had frustrating experiences with medical doctors who dismissed her concerns or didnt seem to have time for her. Shed never gotten good treatment for her psoriasis, or for other conditions including migraines and severe chronic stomach pain. So when she started working with a naturopath, it felt like finally she was going to have someone listen to her and take her symptoms seriously. She had hope that she would finally figure out what was going on.

Many people have similar reasons for being attracted to complementary, alternative, and integrative medicine. This industry accounts for a $413 billion segment, or about a tenth of the $4.4 trillion wellness industry. A 2017 report found that about half of Americans have tried some form of alternative medicine during their lifetimeabout 20 percent have used it instead of conventional medicine, and about 30 percent have used it in addition to standard medical treatment. In a healthcare system where so many people feel like theyre being given one-size-fits-all treatments and not seen as whole people, its no wonder so many of us are interested in alternatives that purport to offer something different.

Unfortunately, though, alternative and integrative therapies are in many ways untested and unregulated. They can also be downright dangerous. Take herbal and dietary supplements, for example; supplements are legally prohibited from being tested for safety and efficacy before going to market in the U.S. That is a result of a 1994 law that was enacted thanks to significant supplement-industry lobbying.

Several studies have found that some supplements sold in popular nationwide vitamin chains may be adulterated with undisclosed pharmaceuticals and other drugs not listed on the label. This can include things like weight-loss supplements laced with synthetic amphetamines. Even when a supplement is found to be unsafe, FDA recalls and warning letters to manufacturers often dont result in any changes; harmful products may remain on store shelves for months or years, with profoundly damaging effects. One study found that supplements contribute to 23,000 emergency room visits every year, with more than 2,000 of those people (9 percent) going on to be hospitalized.

Many people are wary of Big Pharma, sometimes with good reason (although sometimes those fears are being whipped up by someone trying to sell you something). But at least pharmaceutical drugs are regulated and required to be tested for safety and efficacy before going to market. With supplements, thats simply not the case.

When you feel let down by the conventional healthcare system, you may think theres no harm in trying supplements or other alternative, wellness-oriented treatments, which are framed as being natural, holistic, and gentle. Unfortunately, theyre not as harmless as theyre made out to be.

I interviewed a woman named Jennifer, who struggled for several years with digestive issues including constipation, bloating, and pain. Feeling frustrated by a lack of answers from conventional healthcare providers, she turned to a functional-medicine nurse practitioner, who put her on a strict diet and supplement regimen, believing her issues stemmed from a supposed gluten intolerancea common belief in many corners of wellness culture.

At first, Jennifer felt heard and understood by this provider, but then she had another bad flareup of her digestive issuesexcept this time, she started experiencing a new kind of pain that was sharp and persistent. She mentioned this to the functional-medicine nurse practitioner, who chalked it up to systemic inflammation and said, essentially, thats just how it goes.

Feeling dismissed yet again, Jennifer sought out another providerthis time, a mainstream physician who specialized in digestive disorders. This new gastroenterologist actually did an abdominal examsomething the functional-medicine practitioner had never doneand thought maybe it was her gallbladder, so he sent her for an ultrasound the following day. What they found was far worse: it turned out to be a rare but aggressive type of tumor, located in her pancreas and interfering with critical blood vessels. She ended up having surgery the day before her 38th birthday, and the surgeon told her that if they hadnt removed it, she wouldnt have lived to see 45.

Of course, this is an extreme case, but Jennifers experience highlights a troubling issue with wellness approaches: many supposedly holistic providers can get so laserfocused on what they think is at the root of a persons problema food intolerance, a supposed fungal infection or parasite, a leaky gutthat they might overlook basic aspects of patient care and miss whats actually going on for their clients. And that can have deeply damaging and even deadly consequences.

Back in the early 2000s, while first dabbling in wellness approaches, alternative and integrative medicine were still on the fringes. Two decades later, theyve exploded in popularity. Many wellness influencers have racked up millions of followers by promoting bizarre, non-evidence-based food restrictions and other out-there treatments. Celery juice is being hawked as a cure-all, people with perfectly normal blood sugar are being encouraged to wear continuous glucose monitors, and everyone is being made to fear gluten, even though celiac disease only affects one percent or less of the population.

Social media isnt to blame for everything, but it does have a lot to do with the spread of these and other weird ideas about wellness. Even casually viewing or liking wellness influencers pages can cause sophisticated algorithms to serve up increasingly extreme diets and harmful practices. The algorithms are designed to maximize engagementto keep us on the platforms for as long as possible so that we can be served more ads. Unfortunately, what does that best is novel and controversial information. Thats why extreme and unsubstantiated diet claims get amplified more than benign and commonplace posts about nutrition, leading users down rabbit holes of misinformation and disinformation. Recent reports have shown that teen girls who sign up for platforms like Instagram and TikTok that are seeking healthy-eating or weight-loss advice end up getting pushed to pro-eating-disorder content pretty quickly.

But its not just young girls who sufferits all of us. Beyond even the algorithms, social media flattens sources of information, so that doctors and scientists are presented in very much the same way as an influencer speaking solely from their own experience. The influencer who has more followers lends them the appearance of trustworthiness. Sometimes its not even an influencer per se, but just a regular person whose testimonial about a certain wellness practice goes viral. Theres certainly nothing wrong with sharing personal experiences; its powerful and important in many instances. It can help others find connections and support that they arent getting from the healthcare system. In matters of wellness, however, it can be dangerous to model your own behavior on a social media personality whose only real evidence is this worked for me.

This flattening of information sources also creates a relativism that can easily be exploited by purveyors of mis- and disinformation. Not only does social media often give greater reach to influencers who may not know what theyre talking about, but it also places well-conducted scientific research on the same footing as anecdotes and non-peer-reviewed preprint studies. This then blurs them all together in one endless scroll. In the process, it can create the illusion that all of these sources are equally valid, which may allow false information to gain traction.

Lest this all sound too bleak, know that there are some helpful strategies for navigating wellness culture. Individual behavior alone is not enough to free us from the wellness trap. We need change at the cultural, institutional, and policy levels to help undo the harms of wellness culture and create a society that truly supports wellbeing for everyone. As an individual though, there are a number of actionable things you can start doing right now to help keep from getting ensnared in the wellness trap.

One is to try to approach alternative and integrative medicine, and the wellness industry in general, with as much critical thinking and skepticism as you would conventional medicine. Dont assume that alternative medicine or supplements are any less problematic and profit-driven than their conventional counterparts. This goes even if theyre framed as being natural or holistic. In many cases, wellness recommendations are based on claims that are highly speculative or downright false. Its completely understandable to want relief from symptoms, and to feel unheard or underserved by the conventional healthcare systembut remember that the wellness industry capitalizes on those feelings.

To help get back in touch with your natural skepticism, consider taking a step back or even a full-on break from social media, and recognize how it pushes us toward increasingly extreme content that isnt necessarily backed by good evidence. You might reflect on how social media pulled you down rabbit holes you hadnt planned on visiting. You can also spend some time getting back in touch with your own deeply held beliefs and values, without the influence of algorithms.

In addition to setting limits on technology, it can be helpful to set boundaries with the people in your life. This may include, perhaps, conveying to any wellnessculture adherents in your life that you love and support them, but that youre on a different path. If friends and family members cant stop talking about their latest wellness plan, candida cleanse, or autoimmune protocol, you might share with them that those types of things have been harmful to you. You can also express that you would rather not discuss the topics of health and wellness.

Finally, when you do come across wellness information online, you can use a method called SIFT, developed by a researcher at the University of Washington named Mike Caulfield, who studies digital media literacy. SIFT stands for its four steps:

SIFT is meant to help people think twice before reflexively sharing or acting upon unverified information. The process involves quickly moving away from the actual content of the misinformation and focusing on the context so that youre not wasting precious time trying to dissect dubious sources. The goal of disinformation is to capture attention, and critical thinking is deep attention, Caulfield wrote in 2018. Whenever you give your attention to a bad actor, you allow them to steal your attention from better treatments of an issue, and give them the opportunity to warp your perspective. So instead of doing a deep dive into misinformation to try to understand it from the insidewhich is what we might traditionally view as critical thinkingyoure better off seeking out other, more credible sources to put the information into context.

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The Wellness Trap: Break Free from Diet Culture, Disinformation, and Dubious Diagnoses, and Find Your True Well-Being - Next Big Idea Club Magazine

Editors Note: In Hey, Health Coach, Sarah Hays Coomer answers reader questions about the intersection of health and overall well-being. Have a question? Send her a message (and dont forget to use a sleuthy pseudonym!).

Hey, Health Coach,

My teenage boys (ages 14 and 17) dont like eating vegetables. They only eat raw carrots, gem squash and cucumbers. Can I give them veggie pills for extra nutrients?

L

Watching kids turn down healthy fruits and vegetables can be so frustrating. It can be worrying, too, especially for a parent who loves their kids.

Research shows that picky eating can stem from many sources, including an ancient evolutionary tendency to avoid consuming unknown (and possibly toxic) substances in the wild, childrens unique personality styles and parental feeding practices.

Whatever the cause of your teens preferences, your instinct to look for alternative sources of nutritionrather than trying to force them to eat things they actively dont likeseems well-advised. Picky eating habits tend to develop when parents either punish, bribe or reward their children regarding their eating behaviors.

This dynamic can feel like a catch-22, though. Do you push or give up? What about your responsibility to keep them healthy? Food is one of few ways kids can exert their autonomy in a world where they have limited control over their surroundings. Every parent has to approach this dilemma based on the dynamics of their own family, but, in my experience as a coach, if you force kids to eat, their resistance is likely to become even more entrenched.

Your sons have specific boundaries around which vegetables theyll eat, but they are willingly choosing to eat carrots, gem squash and cucumbers. As they say here in Nashvillethat aint nothing. It gives you a place to start, and, since they do like some vegetables, odds are theyll learn to enjoy more of them eventually.

Fruit and vegetable pills are one option for bridging a nutritional gap until a persons tastes expand, and there are lots of things you can do to support their health in the meantime.

Read this article:

Fruit And Vegetable Supplements: A 2023 Guide Forbes Health - Forbes

Targeting teenagers and young adults, videos on social media platforms tout SARMs as a quick or easy way to improve physical appearance, gain muscle mass, or increase athletic performance, the FDA warning reads. The reality isSARMs are potentially dangerous.

The concocted chemical substances, which mimic the effects of testosterone and anabolic steroids, are not FDA approved and are often marketed as dietary supplements or sold for research purposes only without warnings on the labels.

SARMs cannot be legally marketed as dietary supplements or drugs for human use, the FDA emphasized in a video accompanying the warning. These products are not worth risking your health for a few extra likes.

Among the potential side effects listed are increased risk of heart attack or stroke, psychosis and hallucinations, sleep disturbances, sexual dysfunction, liver injury and acute liver failure, infertility, pregnancy miscarriage, and not least testicular shrinkage.

SARMS are not legitimate dietary supplements; they are unapproved drugs,Steve Mister, president and CEO at the Council for Responsible Nutrition (CRN) told NutraIngredients-USA.While some SARM-containing products masquerade as being supplements, these products are patently illegal.

He added that in 2018, as the industry was seeing an increase in these products, CRN developedvoluntary guidelineswith its members against the distribution or marketing of dietary supplement products containing SARMs. This was accompanied by the launch of a#SARMsCanHarm campaignto raise awareness of the potential dangers among consumers.

Despite its clear stance, FDA said that it continues to receive adverse event reports associated with SARMs use and acknowledged that the real number of adverse events is likely higher due to underreporting by reluctant or uninformed consumers.

In the past, the FDA has issued warning letters to companies selling unapproved products marketed as SARMs, in addition to pursuing select criminal actions against distributors of these products.

Just this month,an Idaho man pled guiltyto a federal felony for selling over $4.4 million in product through his SARMTECH company website and faces a maximum penalty of three years in federal prison. Asearch of FDA recordsreturns over a dozen additional convictions tied to the smuggling, misbranding and distribution of SARMs. In one of the biggest cases, a federal court sentenced the founder of Blackstone Labs to 4.5 years in prison and ordered him to forfeit $2.9 million for conspiring to sell SARMs and other products as dietary supplements. He wasreleased just before Christmas last year after serving 11 months.

The latest consumer advisory follows a similarFDA letter issued in 2017against SARMs use in body building products, raising questions as to whether much has changed in the last six year.It was accompanied by three warning letters to companies that represented the best snapshot of the issue,an FDA spokesperson said at the time.

Surely, consumer warnings and advisories have their place but if the FDA is serious about eliminating the illicit SARMs market, it will need to be more consistent in its enforcement operations against the marketers, Rick Collins, founding partner at Collins Gann McCloskey & Barr, told NutraIngredients-USA. Perhaps enforcement administrators and field agents have bigger fish to fry.

Although he noted that there must be more dangerous drug product markets out there and that government resources are limited, he added that spotty and inconsistent enforcement actions tend to suggest to some in this market that the Government doesnt really care so much, despite the advisories every few years.

Companies who continue to market these ingredients as dietary supplements should face swift and strong enforcement actions by the FDA, CRNs Mister said.

In 2018, US Senators Orrin Hatch (R-UT) and Sheldon Whitehouse(D-RI) introduced a legislative solution called the SARMs Control Act. Although never passed, the bill would have added SARMs to the federal list of controlled substances and passed enforcement jurisdiction from FDA to the U.S. Drug Enforcement Agency (DEA).

Im poorly inclined toward any proposed law that expands the war on drugs into the fitness market and criminalizes not just marketers but otherwise law-abiding end users, Collins commented. For example, someone who walked into an independent health food store and bought a SARMs product for personal use could be arrested and prosecuted as a federal drug criminal for its possession immediately upon the law taking effect.

When the act was presented, the American Herbal Products Association, Consumer Healthcare Products Association, Council for Responsible Nutrition, United Natural Products Alliance and the US Anti-Doping Agency expressed their joint support for the initiative.

I think there are better ways to crack down on the market, one of which is simply to enforce the existing laws in a more consistent and expansive way, Collins added.

Read the original post:

FDA: SARMs not worth the health risk 'for a few extra likes' - NutraIngredients-usa.com

As blissful as the idea of drifting off to sleep is, sometimes it can be really hard, especially for someone who deals with chronic insomnia, restless leg syndrome, or any number of other sleep-disrupting conditions. For many people, the go-to fix has been to pop a melatonin pill or chew on a melatonin gummy. A 2022 survey by the National Sleep Foundation found that 27.4 percent of adults take melatonin as a sleep aid and that more than five times as many US adults used melatonin in 2018 as in 2000.

However, if you're part of that 27 percent, you may want to take note of the most recent research on the popular supplement: a new research letter published in JAMA Network found that you can't exactly trust what's on the label of a melatonin supplement.

Specifically, 22 out of the 25 melatonin gummies examined contained different amounts of melatonin than what was listed on their labels, reports The New York Times. One gummy contained 74 percent of the amount of melatonin on the package label, another had 347 percent of the labeled amount, and finally, one product contained no melatonin at all, but did contain cannabidiol, or CBD. (It's "currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement," per the Food and Drug Administration, but there are plenty of products on the market that currently do so.)

This isn't the first bit of research to suggest melatonin supplements can be wildly mislabeled. In a 2017 study published in the Journal of Clinical Sleep Medicine, researchers found that, of the 31 supplements they analyzed, the actual melatonin content ranged from -83 percent to +478 percent of the label amount. It also noted that a particular product varied by as much as 465 percent from bottle to bottle meaning you could buy the same exact supplement and get a different dose. Even more worryingly, this study found that eight of the supplements tested contained serotonin a naturally produced hormone, yes, but also a controlled substance used in the treatment of several neurological disorders.

This doesn't bode well for those who take and trust that melatonin gummies are a safe way to help get to sleep. But it's also a glaring reminder that supplements, overall, are kind of sketch. ICYDK, supplements are largely unregulated, meaning you can never be sure exactly what you're getting (but more on that below).

Here's what you need to know about the safety of melatonin gummies and any other supplements you might be taking or see come across your TikTok feed.

"In general, and for adults, I think the answer is yes, most of the time," says family physician Mark T. Loafman, MD. Melatonin is a naturally occurring hormone in the body and is therefore considered safe. Experts also don't believe that melatonin can be addictive or habit-forming.

As a supplement, "there's fairly good evidence that a 'small' supplement dose of oral melatonin shortens the time it takes to fall asleep by anywhere between 10 and 50 minutes," Dr. Loafman says. Specifically, it may be helpful if the time it takes to fall asleep after lights out is uncomfortably long and when other attempts to sleep are not working.

That said, the dosage recommendation for adults is small. Specifically, Cleveland Clinic recommends starting at one milligram and increasing that dose by one milligram (never exceeding 10 milligrams) if needed. But if your melatonin pill doesn't contain the dose it says it does (as the new research suggests may be the case), are you in danger of unintentionally taking too much? And what might happen if you do?

One of the biggest concerns presented by this new research (and the older research, for that matter) is the idea of getting too much melatonin. After all, if one of the tested gummies had 347 percent of the labeled amount, that's got to be one heck of a dose. But can you overdose on melatonin? And what side effects are there if you take too much?

TBH, we don't have all the answers. "Taking too much, or overdosing on melatonin, is also an area in need of formal research," Dr. Loafman says. But there's good news: "The limited studies available have not shown significant adverse effects, which is some reassurance," he says.

That said, there are a couple potential risks, in theory, he says. Higher doses of melatonin are thought to suppress the hormone secretion and regulation in your hypothalamus, pituitary gland, and gonadal glands, for example. So, "higher doses of melatonin over time may increase immune system reactivity," Dr. Loafman says, which could exacerbate immune-mediated conditions (those caused by abnormal activity of the immune system, such as multiple sclerosis or psoriasis. "Again, these are theoretical but are also based on good science," he notes.

In the short-term, taking a megadose of melatonin can cause nightmares or headaches, neurologist Alcibiades Rodriguez, MD, told POPSUGAR in September 2020. You could also experience nausea, dizziness, or daytime drowsiness, which Mayo Clinic describes as a "hangover effect." In one example cited by Poison Control, a 66-year-old man took too much melatonin and it resulted in lethargy and disorientation. He woke up feeling "drugged" and couldn't recall the events of the night before.

If you think you've taken too much melatonin, seek guidance from Poison Control via its online tool or by calling 1-800-222-1222. And if you find yourself experiencing any of those side effects frequently after taking a melatonin supplement, it could be to blame. In this instance, Dr. Rodriguez recommended scaling back on the dosage and speaking with your doctor. And since recent research is showing some brands contain much more melatonin than what's listed on the label, if taking less of one brand isn't alleviating symptoms, you may want to switch to a new one entirely.

Another area of concern around melatonin gummies, specifically, is kids' safety, as children can confuse the gummies for candy and consume too many. "There have been an increasing number of calls to Poison Control centers regarding children accessing and ingesting higher dose quantities of melatonin, for which short-term surveillance is provided, but no long-term studies that we can learn from," Dr. Loafman says.

Over time, it's possible that the effects high doses of melatonin have on hormones could "alter and accelerate the onset of puberty," Dr. Loafman warns, adding that no long-term studies have proven that's a risk.

Regardless, he advises against giving melatonin to any children under 5 and suggests speaking with your child's doctor before giving older kids the supplements.

The Food and Drug Administration regulates supplements as foods, not drugs. That means the organization does not need to test or approve dietary supplements for safety and effectiveness, nor do they need to approve the marketing or labeling. It's "the responsibility of dietary supplement companies to ensure their products meet the safety standards for dietary supplements and are not otherwise in violation of the law," per the FDA, which means it's a bit of an honor system.

"Supplements are largely unregulated, which leaves each manufacturer a wide range of flexibility on what their products contain and what health benefits they claim, so it's really a matter of buyer beware," Dr. Loafman explains. "Similarly, doing your own research on vitamins and supplements is limited to the research that is available, which is often based on small studies and subject to marketing goals."

It's important to keep that in mind when considering studies like the new one presented here. With so much money and marketing behind supplements but little actual oversight, it's difficult for consumers to know exactly what they're getting. (Add on celebrity backing of supplement brands and misinformation and hype spread by social media, and the whole industry seems a bit sus.)

One of the best things you can do is look for products that have been independently verified for quality and purity by the US Pharmacopeial Convention (USP), a nonprofit organization recognized by the FDA, Dr. Loafman says. Poison Control agrees. Look for its gold USP seal on supplement labels. "USP performs testing on vitamins and supplements to verify both the contents and the dosages the product contains. USP and other certifying bodies do not evaluate the purported health benefits or the overall safety, but they do provide peace of mind on contents," Dr. Loafman says.

It's also worth noting that supplements of any kind including melatonin can interfere with certain health conditions and some types of medicine, per Mayo Clinic. For that reason, Mayo Clinic recommends talking to your doctor before taking anything new or if you start to experience any side effects.

Link:

Are Melatonin Gummies Safe? Here's What (Kinda Scary) New Research Says - POPSUGAR