Dietary supplement promotion regulations

Disease prevention and treatment functions must not be claimed. All function promotions cannot exceed the scope of suitable groups and health care functions approved during product filing/registration. Any claimed effect must be supported by authoritative and solid evidence such as scientific literature and national standards. Enterprises that violate the rules can be fined up to 20 times the value of the goods. In serious cases, the business and even production qualifications will be revoked.

A while ago, I was reviewing a press release for an imported fish oil brand. The operations girl pointed at several SCI papers on her computer and argued with me: "Look, these are all published studies. They clearly state that high-purity EPA can lower blood lipids. Why can't I mention even a word of it on the details page? ”This is actually the most common misunderstanding made by many practitioners who are new to the industry: they think they can just say whatever they want if there is research support, and they completely fail to understand the underlying logic of the current regulations.

Most of the old people who are responsible for compliance in the industry believe in the "strict" logic: as long as it is not printed in the "health function" column of your product's blue hat approval document, even if the entire universe recognizes that this ingredient is useful, you cannot mention it. This is really not an alarmist statement. Last year, there was a brand in Shanghai that made imported coenzyme Q10. It added the sentence "Improve myocardial energy metabolism and relieve fatigue" on the details page. However, the only approved function of its product on the approval document was "enhancing immunity." The city supervisor directly fined it 120,000. When I appealed, it was useless to submit seven or eight domestic and foreign studies - regulations are regulations, and if your product does not have approved functions, it is wrong.

However, in the past two years, many practitioners have also called for more flexible judgment standards, which is the so-called "reasonable claim school": If I am promoting the recognized physiological functions of the nutrients themselves, and neither say they can cure diseases, but are also supported by authoritative evidence, can I be moderately liberalized? For example, vitamin C has an antioxidant effect and calcium helps maintain bone density. These are all public contents written into the "Reference Intake of Dietary Nutrients for Chinese Residents". We can't help but mention it, right? In the past two years, supervision has actually been loosening up. I have seen a vitamin C effervescent tablet brand write on the details page that "supplementing vitamin C can help maintain the health of skin and mucous membranes." As long as it is not exaggerated and not related to diseases, it will basically not be judged as violating the regulations. ； But if you dare to write "Vitamin C can prevent colds", I'm sorry, you will get a fine if you turn around - after all, preventing diseases is the publicity authority of medicines.

There is another minefield that is most easily ignored by everyone: whether it is the merchant's own promotional page, or the oral broadcast of the anchor's product, or even the user's positive comments that you proactively release in the buyer's show, there must be no disease-related expressions, and personal experience of use cannot be used to imply the effect. Last year, there was a head anchor who wore glucosamine chondroitin and said casually, "If your parents have joint pain, this will help." He directly fined the brand more than 800,000 yuan, even if the anchor was telling the truth about his family - you are implying that the product can cure joint pain, and you have stepped on the most untouchable red line.

There is actually a lot of controversy over this set of regulations in the industry. Many export companies complain that many functional claims that have been allowed to be labeled by the EU and FDA, such as DHA helping infants and young children’s neurodevelopment, and EPA helping reducing the risk of cardiovascular disease, cannot be mentioned at all in China because they are not included in the health function catalog, which is equivalent to wasting the core advantages of the product. To be honest, I sometimes feel a little pity. I have come across a brand that makes algae oil DHA before. The raw materials are top-notch in the industry and the clinical data is complete. However, when promoting it, they don’t even dare to mention “helping brain development” and can only label it as “supplementing DHA”. Many consumers have no idea what the advantages of buying this product are, which is really a bit frustrating. However, some friends from the regulatory side have talked privately. There is actually no way to control the situation now. In the past few years, too many businesses promoted dietary supplements as "miraculous medicines." Many elderly people stopped taking antihypertensive drugs and took deep-sea fish oil. In the end, there were many cases of strokes and hospitalizations. Strict supervision is essentially to protect consumers.

I have been working in the field of health compliance for almost 6 years, and my advice to my colleagues is actually not that complicated: Don’t always try to take advantage of the loopholes, and make sure it is clear before promoting it: first check the approval documents of your own products, and be assured of the approved functions.； Then check the list of allowed claims in the "Regulations on the Management of Claims of Nutrient Supplements". As long as the recognized functions of the ingredients themselves are not related to diseases, there is no problem if they are mentioned in moderation. ； Finally, for everything you dare to write, you must prepare authoritative evidence in advance. Don’t use small experiments with dozens of people or even self-media articles as evidence. After all, supervision is becoming more and more detailed, and consumers are becoming more and more rational. If you follow the rules honestly, you will go further than any wild approach.