Daily Archives: September 27, 2021

Parrot wants pro pilots to test its new ANAFI Ai drone – DroneDJ

Posted: September 27, 2021 at 5:36 pm

If youre a professional drone pilot who routinely uses flying robots in complex environments, you would want to check out this Early Access Program being offered by Parrot. The drone maker is handing out the new ANAFI Ai drone for a loan period of two months to test users who can help the company to evaluate the machines 4G standards.

The European drone manufacturer is looking for professionals from inspection, construction, infrastructure, energy utilities, public safety, surveying, agriculture, and defense sectors to:

Inspect buildings with strong 4G connectivity during built-up urban missions. Map long distance electric power lines in 48 MP at 1fps. Quickly generate 3D models of a building just by clicking on its land register in the new FreeFlight 7 App. Create precise flight plans in complex environments thanks to a unique obstacle avoidance system. Benefit from the embedded Secure Element to protect sensitive data. Develop flight missions with AirSDK and contribute to Parrot open-source piloting App.

In return, youd be expected to stay in contact with the Parrot team throughout the loan period, sharing datasets, photogrammetry 3D models, flight logs, and usage feedback.

Readers may recall, the ANAFI Ai is the first commercial drone to use 4G LTE as the primary data link between the drone and the operator. The bird features a uniquely designed omnidirectional obstacle avoidance system, 48 MP imaging sensor, 4K 60fps videos, and up to 32 minutes of flight time in an airframe that weighs less than 2 pounds.

In the United States, Parrot is teaming exclusively with mobile network provider Verizon and its drone software subsidiary Skyward to help operators utilize 4G out of the box. However, despite the splash made by this first-of-its-kind connected drone, some industry experts have questioned whether a 4G connectivity premium would actually be worth its price. The results from this program would, no doubt, help to answer those questions as well.

Interested? You can apply for the ANAFI Ai 4G drone Early Access Program by filling in this form here.

Read more: Sony Airpeak S1 drone hits pre-order in Japan; US launch soon

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Parrot wants pro pilots to test its new ANAFI Ai drone - DroneDJ

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Could these AI robots replace farmers and make agriculture more sustainable? – Euronews

Posted: at 5:36 pm

Robots powered by artificial intelligence could farm more sustainably than traditional agriculture, claims one Silicon Valley company.

Agricultural technology start-up Iron Ox says that its mission is to make the global agriculture sector carbon negative. And they have just secured 47 million ($53 million) from investors including Bill Gates.

CEO Brandon Alexander can't be accused of lacking experience when it comes to food production. He spent every summer of his childhood on his grandparents farm, picking cotton, potatoes, or peanuts under the Texas sun.

Yet, with a degree in robotics "precisely to escape farm work", Alexander says he couldn't shake the feeling that he could have a bigger impact working in agriculture.

A feeling that only grew when he learnt that 40 per cent of food grown worldwide is thrown away before reaching our shopping baskets.

Alexander left his previous job in 2015 to take a six-month road trip through California. He wanted to discover first-hand what problems American farmers were facing and figure out how automation could help.

Along the way, he learnt about extreme water scarcity, difficulties of finding labour, and a whole host of other issues. Armed with this knowledge, Alexander launched a startup focusing on autonomous farming in 2018.

"To really eliminate waste, to really get to that next level of sustainability and impact, we have to rethink the entire grow process," Alexander explains.

Now, in the company's greenhouse in Gilroy, California, two robots named Grover and Ada grow basil, strawberries and other crops using a hydroponic system.

Iron Ox's system uses artificial intelligence to ensure each plant gets the optimal levels of sunshine, water, and nutrients. Grover is in charge of carrying the plants to the dosing station, where it hands off the produce to Ada, a robotic arm.

The stop is akin to a doctor's visit. Sensors help to check the water for nutrients levels and any other ingredients needed for healthy growth. After the examination, customised doses of nutrients can be automatically delivered to the plants through the hydroponics system.

This way, the farm produces less waste and uses only the amount of water it really needs. Data is continuously collected from the crops helping the AI learn what the plants need - improving their yield and reducing their environmental impact.

Watch the video to see these AI-powered robots in action.

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Could these AI robots replace farmers and make agriculture more sustainable? - Euronews

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Sell real estate better with AI and fully automated marketing – Inman

Posted: at 5:36 pm

Utilizing digital marketing when selling real estate is key to ensure that you optimize your sales operations. However, the digital landscape is changing rapidly and as AI solutions are becoming more and more powerful, the industry needs to be constantly alert to the commercial opportunities that come with them. Implementing AI and automation into your digital marketing strategy will provide competitive advantages and create more streamlined processes.

Recent statistics from Statista document that 97% of all home buyers in the United States in 2020 used the internet for home searching. This percentage alone is a reason to investigate if your business is reaching the full potential of its digital marketing strategy.

Because of low mortgage rates and remarkably high demand compared to supply, much due to the pandemic and work from home opportunities, the housing market in the US is booming right now. However, this is not the case for all areas and for all housing types. And like all cycles, this sentiment will change again, either slowly over time or due to an unforeseen disruption in the market.

Your real estate business will be much better equipped to perform well throughout any type of cycle or market condition with a proactive digital marketing strategy in place. By investing in an AI-driven and automated digital marketing solution, you will increase your chances of delivering superior results to your clients while streamlining the internal operations for your agents.

Marketers own scientific research from 54,000 property transactions carried out over a period of almost three years documents that the implementation of AI and automation in your marketing operations can result in an average return of 13.5 times the marketing investment for one of the most normal housing types. If the ambition is to do well for your clients, such results cannot be ignored by real estate Realtors.

For any successful property transaction, the goal should always be to identify, get in contact with, and present the given object to the one(s) that are most interested in the property. So, the million-dollar question is how to accomplish that, and how to do it in the most effective way. A defined strategy for targeting the most likely interested audience is key for converting perceived interest to real leads, and ultimately to achieve the best possible result for both the home seller and the realtor. A firm focus on quality rather than quantity in your approach to leads accumulation will increase the chance for utilising the potential of each individual property. To succeed with this, there is no alternative to advanced, automated solutions and efficient use of relevant data.

A proven digital marketing solution, with integrated automation and AI capabilities, will normally have all the tools and capabilities to run a streamlined marketing operation for both small and large real estate firms. The results will be immense for those that transition from more traditional and manual marketing operations and substantial for those moving from less advanced digital solutions. Accordingly, agents will also free up a lot of time, enabling them to focus more on what they normally are good at: connecting directly with potential buyers.

Marketing properties through an AI-powered, automated platform includes many key parts. The most important are (1) finding the right target audience, (2) tailor the communication thereafter, and (3) advertise in the right places at the right time. Your digital marketing solution will also conduct all necessary campaign management following the launch of a campaign, including optimisation and making sure that the overall budget is spent in the best possible way.

By combining historical data, AI-driven technology, and real-time analysis, Marketers intuitive products ensure you market your properties with the right content, to the right people, at the right time, and in the right channels. The benefits for both you and your clients can be immense. Curious to learn more? Click here to read more about the positive effect of using Marketers AI-powered platform for selling real estate

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Sell real estate better with AI and fully automated marketing - Inman

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Connecticut Retail Sports Betting Clear Final Hurdle, Could Open Before Online Sportsbooks – The Action Network

Posted: at 5:34 pm

Connecticuts first retail sportsbooks could open in the coming days.

Federal officials formally cleared the FanDuel sportsbook at the Mohegan Sun and DraftKings sportsbook at Foxwoods Resort Casino, allowing both to take retail bets. A memorandum of the understanding was published Monday in the Federal Registrar, the final step for both retail books to open.

Neither casino has formally announced an opening date, but officials told the Action Network last month they planned to open soon after they earned final approval.

Connecticuts online sportsbooks are set to launch Oct. 7, ahead of NFL Week 5. DraftKings, FanDuel and a Rush Street Interaction digital sportsbook (likely PlaySugarHouse) are set to open that day.

Connecticut Gov. Ned Lamont and the states two gaming tribes, the Mohegans and Mashantucket Pequots, announced a new gaming compact earlier this year that allows the tribes to open retail sportsbooks at their respective casinos, subject to federal approval.

Lawmakers passed and Lamont signed a companion 2021 bill that will allow the two tribes open online sportsbooks and casinos, which will be regulated by the state government independent of the two tribes respective retail books.

The two tribes, in conjunction with their digital partners, can offer online sports bets, table games, slots and poker statewide.

Additionally, the law allowed a third online sportsbook under the purview of the Connecticut Lottery, which partnered with Rush Street Interactive. The lottery can also open up to 15 retail sportsbooks throughout the state, many of which will be at off-track betting facilities.

Connecticut is the first New England state with multiple legal sports betting brands.

Rhode Island opened the regions first retail sportsbooks in 2018, several months after the Supreme Court struck down the federal wagering ban. The pair of William Hill sportsbooks (now owned by Caesars) at the states two commercial casinos were followed by a mobile app launch months later.

Boston-based DraftKings won a de facto online monopoly in New Hampshire after agreeing to pay more than half its revenues in taxes to the state government in exchange for the exclusive rights to take digital wagers in the state. New Hampshires 2019 sports betting law also permits a handful of retail sportsbooks.

Connecticuts retail and pending online launch could put more political pressure on Massachusetts to follow suit. The regions most populated state has considered online sports betting legislation for three but has not yet passed a bill.

DraftKings highlights a list of sportsbook operators interested in a possible Massachusetts sports betting market. MGM and Wynn have spent hundreds of millions of dollars in full-scale casino resorts in the commonwealth and will push their BetMGM and WynnBet apps, respectively, if permitted by law.

Penn National operates a gaming facility in the state and its Barstool Sports brand was founded in Massachusetts. Other national market leaders such as FanDuel, Caesars, PointsBet and others would likely pursue a potential online sports betting license along with Massachusetts-affiliated companies such as Barstool and DraftKings.

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Connecticut Retail Sports Betting Clear Final Hurdle, Could Open Before Online Sportsbooks - The Action Network

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MLB Best Bets: Baseball Picks, Predictions, Odds to Consider on DraftKings Sportsbook for September 27 – DraftKings Nation

Posted: at 5:34 pm

Not a whole lot of MLB action on Monday, and most of its in the early afternoon. But, there are a couple ways to attack the two later games via DraftKings Sportsbook; heres how.

If you want to sweat out these picks with me, follow me on Twitter: @Nick_Friar.

The Nationals only pulled off one win in their four-game set vs. the Reds, but they still managed to put some runs up on the board throughout their trip to Cincinnati. Washingtons two highest-scoring showings in their last series came against right-handed pitching, which shouldnt surprise anyone.

The Nats have been one of the toughest teams on right-handed pitching throughout September, even though they gave up on 2021 a while ago. And German Marquez already knows what this lineup is capable of, having faced them on Sept. 17 at Nationals Park which isnt a cakewalk for pitchers, but it still isnt Coors Field.

While Rockies pitchers tend to pitch well in Denver, relative to visiting pitchers, Marquez has a 5.18 FIP and 4.61 ERA at home in the second half. As for Colorados relievers, they havent been as bad as Washingtons bullpen this month, but they havent been all that great, either.

When it comes to Marquezs home runs allowed prop: its known hes a groundball pitcher, and hes only given up a homer at Coors in seven of his 17 home starts in 2021. But, five of the Coors outings in which hes surrendered a home run have come in the second half. Given his 2021 HR/9 (1.1) is right around his career mark (1.2), this regression was in order.

Juan Soto hasnt gone deep in three games, so why not do so in his first game at Coors since he dented more than a few baseballs in the Home Run Derby against a fellow 2021 NL All-Star whos looked like anything but that in the second half.

The Mariners havent posted good numbers against left-handed pitching throughout September, yet they tagged Cole Irvin for three runs over five innings when they ran into him on Sep. 22. Thats pretty much how its worked all season: Seattle cant hit lefties, and they hit Irvin hard.

The Oakland left-hander has faced Seattle four times in 2021, giving up three or more runs each time. Only once did he make it through five full innings his last start (Sept. 22), in which he gave up exactly three earned runs over five frames.

While the offense takes care of Irvin, Chris Flexen should be able to do what he typically does vs. Oakland. After the As hit him hard in their first meeting on June 2, the Seattle right-hander has put together three strong starts vs. Oakland. He even managed to punch out eight when he last saw the As a lineup that doesnt K much against righties.

Oakland hasnt been bad against right-handed pitching this month, but Flexen has pretty much been the definition of solid in 2021. Hes had a few hiccups, but he almost always gives Seattle a good chance at a win which probably has something to do with the Mariners winning 20 of his 29 starts this season.

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MLB Best Bets: Baseball Picks, Predictions, Odds to Consider on DraftKings Sportsbook for September 27 - DraftKings Nation

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Notable bets – Tucker’s kick saves one of the most popular weekend bets – ESPN

Posted: at 5:34 pm

It was one of the most popular bets on the board at multiple sportsbooks. Yes, we're talking about the Baltimore Ravens' money-line odds to beat the Detroit Lions, straight-up.

The Ravens' moneyline (they were around -400 favorites) was included in more parlays than any other NFL offering at PointsBet. For every money-line bet on the underdog Lions at BetRivers sportsbooks, there were 22 on Baltimore. By the time the game kicked off, 98% of the dollars bet on the money-line was on the Ravens.

All of those bets were on the line when the longest field goal in NFL history hit the crossbar and caromed through as time expired.

Justin Tucker's 66-yard field goal capped an odds-defying last-minute drive by the Ravens in a 19-17 victory that resurrected the hopes of bettors who had laid the hefty money-line price on Baltimore and thought their bets were cooked.

"Justin Tucker is the bettor's best friend," Jay Croucher, head of trading for PointsBet, told ESPN. "Tucker's kick was the afternoon's defining moment for the results, saving everyone's money-line parlays."

Overall, with the Ravens not covering the 7.5-point spread, most sportsbooks made out alright on the game, but some bookmakers did take a hit. Baltimore's two-point win -- instead of losing outright to the Lions -- caused a "mid-six-figure swing" against the house at BetRivers, according to sportsbook COO Mattias Stetz.

Tom Gable, sportsbook director at The Borgata in Atlantic City, New Jersey, said the Ravens were a popular selection on teasers, a form of parlay that allows bettors to adjust the spread, normally by six points.

"The Ravens were one of the most popular teaser selections of the week, and you could tell by the reaction in the book when that field goal was made," Gable said.

A daily sports betting news and information show (6-7 p.m. ET, ESPN2) that aims to better serve the millions of sports fans who participate in sports wagering and help educate general sports fans with in-depth analysis. Watch

None of it seemed possible with the Ravens down 17-16 and facing a fourth-and-19 from their own 16-yard line with 30 seconds to play. At that point, according to ESPN Stats & Information, Baltimore had a 0.1% chance of winning. But Lamar Jackson connected with Sammy Watkins for a 36-yard completion and a first down, and the Ravens appeared to catch a break when they were allowed to get a play off with three seconds remaining after the play clock originally appeared to have expired.

Tucker then took the field and kicked the longest field goal in NFL history to win the game and keep the Ravens on top in the AFC North.

"Had Tucker missed, the Ravens would have drifted to +200 for the division," Croucher said. "Instead, they're now +110 and remain a slight favorite over Cleveland."

The betting public got off to a hot start on Sunday by piling on the Cardinals, Bills and Browns in the early slate. Bettors were rewarded with stress-free winners.

The Cardinals, who rallied from behind to win and cover the 8-point spread in a 31-19 victory over the Jaguars, attracted the most lopsided action of any team in the early slate. Over 90% of the bets and the money wagered was on Arizona at multiple sportsbooks. "That was probably our worst game," DraftKings sportsbook director Johnny Avello said.

"The only game of consequence that went against the public [in the early games] was the Chargers," said BetRivers sportsbook manager Zach Schlouch.

"I was actually happy with a very small loss after the morning games, because we lost all three of our biggest decisions. We went 0-3," MGM race and sportsbook director Jeff Stoneback told ESPN on Sunday afternoon.

The Dolphins' rally to cover the 3.5-point spread in a 31-28 overtime loss to the Raiders was a big win for bookmakers, especially those in Las Vegas. "Miami covering saved us quite a bit," said John Murray, executive director of the SuperBook at Westgate Las Vegas.

The Raiders' opening win over the Ravens on Monday night in Las Vegas produced the biggest loss for MGM books in Nevada that Stoneback, a 20-plus-year veteran, can recall. Sunday's Raiders game against the visiting Dolphins was setting up to be a similar result. There were seven times more bets on the Raiders than Miami, and more than three times as much money.

"We're going to run into that every week now, as long as [the Raiders] are winning and at home," Stoneback said. "Last year, it didn't seem like they were the home team yet. Nobody could go to the games, but now everyone's jumping in, and it doesn't hurt that they're starting out 3-0."

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Deck Prism, a Las Vegas-based company that provides live updating odds during games to sportsbooks, shared what its predictive model thought of the underdog Chargers' late-game decisions in a 30-24 win over the Chiefs on Sunday. With the game tied 24-24 with 48 seconds left, the Chargers were facing a fourth-and-4 and elected to go for it -- instead of attempting a field goal with their struggling kicker in windy conditions.

Deck Prism's model suggested that this was the wrong decision, given an average kicker in typical weather conditions. Under normal circumstances, the Chargers were 24% to win by going for it, whereas they would've been 26.5% to win if they attempted the field goal. Yet the wind was howling at Arrowhead Stadium. Being unable to trust their kicker cost the Chargers in that situation. And then, they were called for a false start before their attempt on fourth down.

"After the false start, we made going for it 18.5% to win and kicking at 24.5%," Deck Prism co-founder Ed Miller told ESPN. "So that was a real rough spot not to have a kicker."

The Chargers picked up the first down, went on to score a touchdown and held off the Chiefs on the ensuing drive to preserve their 30-24 win. Also of note, the total on the Chargers-Chiefs game closed at 54.5. Chargers kicker Tristan Vizcaino missed the extra point after the go-ahead touchdown, his second missed extra point of the game, to keep the score a half point under the total. The Chiefs, who were 7-point favorites, are now 2-12 against the spread in their past 14 games dating back to last season.

Bowling Green upset Minnesota 14-10 as a 30.5-point underdog. It's the largest upset since Illinois beat Wisconsin as a 30.5-point underdog in 2019.

Alabama opened as a 20-point favorite over Ole Miss at 2 p.m. PT Sunday at Las Vegas sportsbook Circa Sports. There were more than 10 limit bets placed on the Rebels in the first hours since the game was on the board, and no limit bets on Alabama. By 6 p.m. PT, the number had dropped to Crimson Tide -14.5.

Other notable opening college football lines via Circa Sports:

Indiana at Penn State (-9, 54.5)

Ohio State (-17, 59.5) at Rutgers

Cincinnati (-2, 47.5) at Notre Dame

Oregon (-8, 57.5) at Stanford

Ole Miss at Alabama (-20, 77.5)

Baylor at Oklahoma State (-5, 51.5)

Arkansas at Georgia (-18, 50.5)

Oklahoma (-12, 54.5) at Kansas State

Auburn at LSU (-4, 55.5)

Michigan at Wisconsin (-1, 43.5)

50,000-1: The actual odds, according to ESPN's Football Power Index, of a $25, 16-leg parlay featuring every Week 2 NFL game that a bettor nearly hit last week in Michigan. According to BetMGM, the bettor correctly picked the winners of the first 15 games and needed the Lions to upset the heavily favored Packers in order to win $726,959. The bet was placed using a free promotion and initially wasn't eligible for any type of early cash-out option. However, a spokesperson for BetMGM said its traders communicated with the bettor ahead of the Monday night game and ultimately allowed the bettor to cash out for $133,000 pre-tax.

-5,000: Team USA's odds to win the Ryder Cup heading into Sunday at the SuperBook. The Americans cruised to a 19-9 win. The Ryder Cup attracted approximately 25% of the amount wagered on a major tournament at the SuperBook.

+325: The Philadelphia 76ers' odds to win the Atlantic Division, prior to the news that Ben Simmons is refusing to return to the team. The SuperBook lengthened the 76ers' division odds to +400 and moved the point spread on Philadelphia's season opener from -1.5 to pick 'em.

+210: Oleksandr Usyk's odds to upset Anthony Joshua and win the WBA/WBO/IBF heavyweight titles on Saturday.

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Notable bets - Tucker's kick saves one of the most popular weekend bets - ESPN

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2021 NFL Week 3 Best Bets – DraftKings Nation

Posted: at 5:34 pm

Pat Mayo, Rob Pizzola and Cam Stewart give their 2021 NFL Week 3 Best Bets with their Gold, Silver and Bronze Selections of the Week.

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Week 3 Best Bets | DraftKings Picks | Spreads Picks | Projections

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Mayo: SEA -1.5Pizzola: CHI +7.5Cam: LAR +1.5

Mayo: PHI +4Pizzola: PHI +4Cam: JAX +7.5

Mayo: TySon Williams over 56.5 Rush YardsPizzola: NO/NE over 42.5Cam: WAS +7.5

Gold: 3-0 (6-0)Silver: 1-2 (2-4)Bronze: 2-1 (4-2)

Mayo: Gold 2-0; Silver 0-2; Bronze 0-2Pizzola: Gold 2-0; Silver 0-2; Bronze 2-0Cam: Gold 2-0; Silver 2-0; Bronze 2-0

*All lines from DraftKings Sportsbook

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Pat Mayo is an award-winning video host and producer of long and short-form content, and the host of The Pat Mayo Experience daily talk show. (Subscribe for video or audio). Mayo (@ThePME) won the 2020 Fantasy Sports Writing Association Daily Fantasy Writer of the Year and Golf Writer of the Year awards, along with the Fantasy Sports Trade Association Best Sports Betting Analyst award, and was a finalist for four FSWA Awards in 2020 (Best Podcast, Best Video, Daily Fantasy Writer of the Year, Golf Writer of the Year). His 21 FSWA nominations lead all writers this decade and are third-most all-time. Mayo has been recognized across multiple sports (Football, Baseball & Golf), mediums (Video, Writing & Podcasting), genre (Humor), and game formats (Daily Fantasy and Traditions Season Long). Beyond sports, Mayo covers everything from entertainment to pop culture to politics. If you have a fantasy question, general inquiry or snarky comment, ship it to Mayo at ThePatMayoExperience@gmail.com and the best will be addressed on the show.

I am a promoter at DraftKings and am also an avid fan and user (my username is ThePME) and may sometimes play on my personal account in the games that I offer advice on. Although I have expressed my personal view on the games and strategies above, they do not necessarily reflect the view(s) of DraftKings and I may also deploy different players and strategies than what I recommend above. I am not an employee of DraftKings and do not have access to any non-public information.

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2021 NFL Week 3 Best Bets - DraftKings Nation

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Broken GRAS: Undermining the safety of dietary supplements and food – Environmental Defense Fund

Posted: at 5:33 pm

Tom Neltner, Chemicals Policy Director and Maricel Maffini, consultant

Over the years, we have seen a disturbing approach being taken by some dietary supplement companies to circumvent the Food and Drug Administrations (FDA) oversight. Their strategy undermines both dietary supplement safety and food safety. These companies are leveraging FDAs decision to allow manufacturers to secretly self-certify food chemicals as Generally Recognized as Safe (GRAS) in order to:

We have long-challenged FDAs interpretation of the GRAS exemption in the Food Additives Amendment of 1958 because it results in the agency being unable to fulfill its statutory duty to ensure food is safe.[1] When Congress passed the amendment, the GRAS exemption was expected to be for common substances like oils and vinegar. In this blog, we explain how the agencys flawed approach to GRAS also undermines the safety of dietary supplements.

We call on FDA to revise its GRAS rule to close the loophole it created in 1997 and codified in 2016. Eliminating secrecy by requiring manufacturers to submit safety information would enable the agency to ensure both dietary supplements and foods are safe. If it doesnt, Congress should clarify that FDAs GRAS rule violates the law. As a stopgap measure, FDA needs to improve transparency around its assessment of voluntary GRAS notices it receives and use its enforcement authority to stop the misuse of GRAS.

Apoaequorin as a prime example of GRAS undermining both dietary supplement and food safety

An excellent example of the problem is apoaequorin, a controversial chemical commonly marketed as the dietary supplement Prevagen. An October 2020 article in Wired tells the saga in detail. We are focused on the GRAS-aspects of the story but need to briefly mention that FDA twice objected to the companys NDI notices in 2008 and 2012 for a litany of reasons that include safety concerns. The agency also took a series of enforcement actions that the company claims have been resolved.

A year after FDA objected to the second NDI notice, Quincy Bioscience began selling NeuroShake a protein shake containing apoaequorin as conventional food, presumably based on a self-certification that the chemicals use in dairy products was GRAS. In doing so, it no longer needed an NDI notice if the dose of the chemical in food is similar to what it will offer as a dietary supplement. The company effectively leveraged the GRAS loophole to avoid FDA review of the chemical as a new dietary supplement ingredient.

In late 2014, the company submitted to FDA a voluntary GRAS notice for conventional food use, relying on an expert panel it hired to review the safety information.[2] The notice stated that there had been more than 2,200 instances of user-reported adverse health effects from the chemicals use as a dietary supplement. The reports, primarily consumer complaints, describe memory impairment, anxiety, hypertension, headaches, dizziness, insomnia, nausea, and diarrhea. The company identified 26 reports as serious adverse events, mainly neurological and cardiovascular problems. Despite these reports, two physicians hired by the law firm that filed the notice for the company concluded that apoaequorin was likely not the cause of the serious adverse events. One of the physicians found that there is no alarming pattern of [serious adverse events] which would indicate a safety concern. The other said he found no pattern of events that led me to think there was a particular safety problem with the product.

The company withdrew the notice in 2015. However, this withdrawal did not preclude the company from selling its product. And, as it does for all withdrawals, FDA did not make public any safety concerns with the product. According to the Wired article, FDA had concerns and sent Quincy Biosciences a letter questioning the safety of its NeuroShake stating, we are concerned about the safety of your apoaequorin products because of, among other things, the large numbers of adverse events reported for them. The company continues to offer Neuroshake for sale.

We await FDAs response to our Freedom of Information Act (FOIA) request for its assessment of the GRAS notice and communications with the company[3] about apoaequorin.

Not an isolated incident

While the apoaequorin story is unusually egregious, it is not an isolated incident. In 2014, the Natural Resources Defense Councils (NRDC) Generally Recognized as Secret report[4] identified 275 chemicals from 56 companies that appeared to be marketed for use in food based on undisclosed GRAS safety determinations. The report found that almost all of the chemicals NRDC reviewed were also ingredients in dietary supplements and served no essential purpose in food other than to attract consumers attention. It noted that several dietary supplement manufacturers appear to be making a GRAS determination to avoid having to notify the FDA under both [the Dietary Supplement Health and Education Act of 1994] and the Food Additives Amendment of 1958.

The situation did not change after NRDCs 2014 report. We reviewed 78 voluntary GRAS notices that companies submitted to FDA for review between May 2014 and August 2021 but then withdrew the request. After removing duplicates there were a total of 46 GRAS substances of which 13 were marketed as dietary supplement ingredients. See a few examples in the table below.

GRAS substances have higher safety standard, but NDI has mandatory notice to FDA

In theory, a chemical must meet a more protective safety standard for its use in food to be considered GRAS as compared to its use as a new dietary supplement ingredient. A substance can only be considered GRAS if there is a reasonable certainty in the minds of competent scientists that the substance is not harmful considering three factors including cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in such diet. In contrast, a new dietary ingredient can only be use if it is reasonably expected to be safe. In other words, to be GRAS, there must be a reasonable certainty of no harm as compared to for NDIs where there need only be a reasonable expectation of safety.

Despite the differences in safety standards, in reality, many GRAS substances do not go through a rigorous safety review. FDA allows companies to self-certify the GRAS substances uses as safe in secret using staff, consultants, or an expert panel it has hired with no consideration to conflicts of interest or bias.

Even when the GRAS safety determination is voluntarily submitted to the agency and published, if FDA raises concerns, as with apoaequorin, the company can simply withdraw the notice and continue using the chemical in food. The agencys concerns are only made public if someone chooses to request this information under FOIA. In addition, FDA is sensitive to demanding too much information because it does not want to discourage future notifications; as an agency reviewer said [w]e cannot require anything, as this is a voluntary program and we dont want to frighten anyone away

Daniel Fabricant, a former director of FDAs Dietary Supplement Program and current president of the trade group Natural Products Association, said in the context of apoaequorin that GRAS is pretty compelling, especially if its published. My guess is that somebody higher up in the [Center for Food Safety and Applied Nutrition] looked at that and said we cant make a case The Wired article also quoted Robert Durkin, Fabricants successor at the agency, as saying once this happens [apoaequorin entering the food supply via NeuroShake], the agencys original position back in 07, that the ingredient in question isnt a dietary ingredient, that argument goes away. Through Durkins statement, FDA acknowledges that Quincy Bioscience successfully leveraged the GRAS loophole and circumvented agency oversight of its NDI notice requirement. In their quotes, neither Durkin nor Fabricant acknowledged that the company had withdrawn the GRAS notice.

In contrast to GRAS, the NDI notice is mandatory. It must be submitted at least 75-days before the product goes to market, and the agency makes a formal assessment that is public. There is no option for withdrawal.

Not surprisingly, the rates at which FDA accepts GRAS notices and NDI notices are starkly different, supporting the idea that mandatory agency review with a formal assessment makes a difference. FDA effectively objects to or allows to be withdrawn to avoid an objection for less than 20% of GRAS notices.. In contrast, FDA objects to more than 60% of NDI notices. According to an industry lawyer who said at a 2020 conference that you were uncertain of what the standards for evaluation were going to be, it felt like the bar was being set impossibly high, and so people started looking for an alternative. And thats when we see the rise of interest in the GRAS self-determination process.

Is there a solution to the broken GRAS system?

After FDA adopted the 1997 proposed GRAS rule, we saw a tremendous increase in reliance on the GRAS notice. Formal petitions dropped dramatically in favor of voluntary GRAS notices. Now we see the GRAS rule undermining dietary supplement safety.

The agency needs to revise its rules to fix the GRAS system. If not on its own accord, then in response to a potential court decision or a legislative mandate that makes clear than FDAs GRAS rule violates the law.

In the meantime, as a stopgap measure to improve transparency and help reduce misuse of the GRAS exemption, FDA needs to publicly post online its assessment of a chemicals safety even if a notifier asks the agency to cease evaluating it This will help food manufacturers recognize potential problems with the substance and avoid using it without a more careful investigation. There is nothing in the rules that limit release of the agencys assessment.

Conclusion

When Congress passed the Food Additive Amendment of 1958, the GRAS exemption was expected to be for common substances like oils and vinegar. In 2011, we showed that most new food chemicals were not reviewed by FDA for safety as food additives but were allowed to be used in our food supply by means of industry certifications that the chemicals they produced are GRAS; indeed, we estimated that there were at least 1000 chemicals determined to be GRAS without notice or review to FDA.

FDAs expansive interpretation of the GRAS exemption provided the dietary supplement industry with a path that allows chemicals of unknown safety to enter the food supply without accountability, leaving consumers in the dark and undermining both dietary supplement safety and food safety.

___

[1] When the agency finally formalized its approach in a 2016 rule, EDF, represented by Earthjustice and Center for Food Safety, challenged the rule and are awaiting a court decision.

[2] FDAs 2016 rule does not protect against this type of conflicts of interest or even require an expert panel. In 2017, FDA issued a draft guidance on best practices to convene a best panel that would, if followed, limit this practice. But the agency has not finalized the guidance after four years.

[3] As well as 45 other withdrawn GRAS notices.

[4] The authors of the blog were also the authors of the NRDC study.

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Broken GRAS: Undermining the safety of dietary supplements and food - Environmental Defense Fund

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I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues – Business Divorces in the Food and Supplements Space – JD Supra

Posted: at 5:33 pm

In this episode, Michael E. Burke, partner and co-chair of the Pharmaceutical & Biotechnology industry team is joined by Robert Durkin, an attorney in our Dietary Supplements team, as they discuss issues around business divorces or disputes between companies in the food and supplements space. They will discuss, among other things, post-divorce product regulatory status and related business challenges, as well as strategies that can be employed at the beginning of the business relationship to help mitigate risk if the relationship Seemore+

In this episode, Michael E. Burke, partner and co-chair of the Pharmaceutical & Biotechnology industry team is joined by Robert Durkin, an attorney in our Dietary Supplements team, as they discuss issues around business divorces or disputes between companies in the food and supplements space. They will discuss, among other things, post-divorce product regulatory status and related business challenges, as well as strategies that can be employed at the beginning of the business relationship to help mitigate risk if the relationship goes bad. Seeless-

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I Wish I Knew What I Know Now: Conversations with AGG on FDA Issues - Business Divorces in the Food and Supplements Space - JD Supra

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One Major Effect Vitamin C Has On Your Gut, Says Science | Eat This Not That – Eat This, Not That

Posted: at 5:33 pm

Most of us know vitamin C as a popular cold remedy. However, boosting your immune system isn't the only way your body can benefit from vitamin C. It actually helps you in ways you may not yet realize. The antioxidant power of vitamin C helps to reduce your risk of cancer and other serious diseases, as well as boost collagen levels and help prevent vision loss. And in the last few years, more key studies have found that vitamin c is also linked to gut health.

One of the major effects vitamin C has on your gut is helping to maintain a balance between good and bad bacteria in your gut microbiome. Here's why, and for more healthy eating tips, make sure to check out The 7 Healthiest Foods to Eat Right Now.

According to the Mayo Clinic, you need vitamin C for healing and forming vital parts of your body like muscles, cartilage, collagen, and blood vessels. This essential vitamin has also been proven to help reduce the negative effects of free radicals in your bodywhich are known to lead to heart disease and cancer.

Because your body can't naturally make vitamin C on its own, it needs to get it from food or supplements. Some common vitamin C-rich foods are oranges, kiwis, strawberries, kale, Brussels sprouts, and bell peppers.

It is recommended that adult women get around 75 milligrams of vitamin C per day, and adult men about 90 milligrams. If you're pregnant or breastfeeding, this number increases to between 85 to 120 milligrams a day.

A 2019 study published in Redox Biology found that vitamin C can be used to improve your gut barrier function, which helps your body absorb nutrients and protect you from certain toxins.

Along with improving your gut barrier, vitamin C has been known to help balance out the good and bad bacteria inside your gut. According to Gut Microbes, vitamin C had the most significant impact on gut health compared to vitamins B and D and was proven to help increase microbial diversity, which is necessary for maintaining a healthy gut.

Although vitamin C has positive effects on your gut health, you may experience some uncomfortable digestive issues if you take too much.

RELATED: One Major Effect Vitamin D Has on Your Gut, Study Says

According to the National Institute of Health, excessive amounts of vitamin C can cause gut-related issues like diarrhea, cramps, and nausea, which occur because of the way your gastrointestinal tract reacts to the unabsorbed (or excess) vitamin C.

Although these side effects are uncomfortable, it takes quite a bit of vitamin C to reach this point. The NIH says the tolerable upper limit for adults is 2,000 milligrams a day, which is almost impossible to reach with just foods containing vitamin C.

Although you most likely won't reach 2,000 milligrams with your daily food, you may accidentally take too many vitamin C supplements. For example, there are 1,000 milligrams in a Nature Made Vitamin C tablet, so taking more than one per day could potentially lead to some of these unwanted digestive issues.

For even more tips, read these next:

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One Major Effect Vitamin C Has On Your Gut, Says Science | Eat This Not That - Eat This, Not That

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