Traditional Chinese medicine (TCM) and Chinese food share a good deal in common. This includes not only ingredients, but also combinations of food used as therapies. For example, TCM espouses the consumption of certain specially prepared combinations of foods, considered to be cooling (yin)or heating (yang) foods, to balance forces within the body, maintain health, and treat illness.

TCM is backed by thousands of years of tradition and enjoys the trust of many in China. But it presents challenges for regulators that are seeking to strengthen a system that requires support for the safety and efficacy of drugs on the market and restricts the use of potentially harmful, untested additives in food. For example, Chinese authorities have recently banned poppy capsules because of their opium content, after a high profile story in which a chef was cooking with them in an effort to make his restaurants food addictive.

The latest draft of the Food Safety Law released for public comment in December of 2014 shows that China is increasingly concerned with the addition of drugs to food. Under that draft, those individuals who are directly responsible for a company impermissibly using pharmaceutical additives may be subject to 5-15 days of detention by the Ministry of Public Security.

It should be no surprise then that the National Health and Family Planning Commission (NHFPC), the primary agency for regulating food ingredients, recently issued proposed Administrative Measures on the Catalogue for Substances Traditionally Used in Both and Chinese Medicine (the Measures) to clarify the line between food and drugs. The Agency released the Measures in October 2014, with a deadline for comments ending shortly thereafter.

The Measures establish a catalogue of what substances may be used in both food and TCM. The Measures dictate the conditions for substances to be included in the Catalogue. For example, they must fulfill the requirements for food under the Food Safety Law, as well as be included in the national standards for TCM. They must also be recognized as edible in Chinas Drug Code, and normal use of the substance as a food must not have revealed short- or long-term harms to human health. The Measures also indicate what substances are not permitted to be included, e.g., those have a high rate of adverse events associated with them when used as a drug; those TCM substances that are, by law, protected wild animals or plants; and/or those for which the use might violate national law or not conform to food requirements.

The NHFPC will administer these criteria and amend the Catalogue, releasing proposed revisions for public comment. An amendment will take place when there is new information to consider, whether in the form of a new TCM standard, new adverse events reported, or other information that causes a reevaluation of a given substance or substances. As the NHFPC decides applications for new food ingredients (a separate process), it will consider adding those ingredients to the Catalogue.

While all of this sounds promising for resolving some of the stakeholder confusion that exists in this area, the proposed Catalogue itself (appended to the Measures) is fairly sparse on information. The user gets the Chinese and common English name of the substance, the name of the plant or animal from which it comes, its family or species, and some additional notes about it. But there is very little to indicate under what conditions it may be a food, a drug, or both. And there is little in the way of interpretations of the primary food and drug laws in China that would indicate if and when these categories can overlap. Whats more, while NHFPC primarily decides what can be added to food, the China Food and Drug Administration is in charge of drug ingredients. Yet, for some reason, the Measures do not appear to have been a joint effort between the two agencies.

It is important that Chinese regulators are thinking hard about these lines between overlapping product categories and their related safety issues. However, inclusion in this list, the way it is currently structured, will only answer so many questions, leaving many holes in the regulatory equation for these products.

Well-worded definitions of what constitutes a food and what constitutes a drug and guidance on hybrids would not only answer many of these questions, butthey would also make interpreting catalogues like the one that NHFPC is proposing much easier. Right now there does not seem to be guidance available to accomplish that task.

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China Works to Regulate the Difference between Food and Traditional Chinese Medicine