Latest dietary supplement regulations

The revised version of the "Administrative Measures for the Catalog of Health Food Raw Materials and Health Function Catalog" was officially launched on October 1, 2023, the "Announcement on Standardizing the Labeling of Dietary Supplements and Health Foods" issued by the State Administration of Market Supervision in February 2024, and the "Details for the Supervision of Cross-border E-commerce Retail Imported Dietary Supplements (Trial)" which has just ended its public solicitation for opinions in August 2024 and is expected to be officially implemented before the end of 2024. The actions of all relevant production, import, and sales entities need to be based on the requirements of these three documents as the core criteria.

I have been working in the nutritional compliance industry for 6 years. I just completed the registration process for an Australian fish oil brand last month, and all the pitfalls I encountered were stuck in the detailed requirements of the new regulations. The overseas version of the label that the brand brought over at the beginning was directly printed with "reduce blood lipids and prevent cardiovascular diseases", but was directly rejected in China - according to the requirements of the 2023 version of the raw material and function catalog, ordinary registration-level fish oil can only be labeled "assisted in lowering blood lipids", and all functional claims beyond the scope of the catalog are not allowed, even vague statements such as "protecting cardiovascular disease" are not acceptable. Immediately afterwards, the label warning must be changed: According to the 2024 label announcement requirements, the sentence "This product is not a drug and cannot replace drugs to treat diseases" must be printed in the most conspicuous position on the front of the package. The font size cannot be smaller than other adjacent words, and it must be black and bold. Don’t underestimate this requirement. I have been in contact with a small domestic brand of vitamin C before. Because the font size of the warning was 1mm smaller than the product name, it was fined 200,000 by the city supervisor during a random inspection. It was very unfair, but there was no way to deal with it. The rules were clearly stated.

Regarding these new regulations, the voices in the industry are actually quite divided. Bosses of small and medium-sized brands generally feel that they are too tight: just changing the packaging and going through the registration process again will cost at least hundreds of thousands more. All the old packaging goods that have been accumulated before will be thrown away. This alone can wipe out the profits of the small brand in half a year. But the logic on the regulatory side is also very practical: In 2023, the National Consumers Association received 120,000 complaints about dietary supplements, half of which were false propaganda. I used to accompany the city supervisor to the community to do science popularization. Many aunts and uncles took out the "anti-cancer propolis" and "sugar-lowering magic medicine" they had bought before, and spent tens of thousands. In the end, they found out that it was just ordinary vitamins and honey. After listening to the policy explanation, they patted their thighs. The attitudes of ordinary consumers are also divided: those who often fall into traps feel that the labels are clear now, at least they will not be fooled by the words of Internet celebrity anchors. ； Some people also think that the warning on the label takes up half of the package, and it takes a long time to look through the ingredient list.

In addition to the tightening of supervision on domestic supplements, the cross-border rules that have just been solicited for opinions are the most discussed variables in the entire industry recently. Previously, cross-border imported supplements had always been in a gray area. As long as they were sold legally in the country of origin and entered the cross-border positive list, they did not need to comply with the domestic raw material catalog requirements. However, the new draft for comments clearly stipulates that dietary supplements sold cross-border in the future must either have their raw materials included in the domestic health food ingredient catalog, or must submit proof of legal sales in the country of origin for more than five years and a complete human safety risk assessment report before they can enter the country. The most affected are the NMN supplements that have exploded in the past two years. In the past, many cross-border sellers relied on this category to support 30% of their sales. Now the draft for comments directly places NMN in the scope of "not yet included in the catalog, and cross-border retail imports are not allowed for the time being." Many sellers are now clearing their inventory and are worried. However, many experts in the nutrition field support this regulation: The long-term human clinical data of NMN is still very limited. Ordinary people often take several pills a day. In fact, no one can clearly understand the potential safety risks. It is better to let go slowly than to backtrack when something goes wrong.

The most noisy thing in the industry now is actually the update speed of the raw material catalog: many people engaged in import trade feel that the catalog update is too slow. Many raw materials that have been used safely overseas for more than ten years have not been included in the domestic catalog, resulting in many high-quality products being unable to enter.； Some people in charge of the port said privately that there is a reason to be slow. After all, it is what you eat, and it is not a bad thing to do a few more rounds of safety verification.

To be honest, here’s a little reminder for ordinary consumers: When buying supplements now, whether they are domestic or cross-border, first look to see if there is a blue hat logo, and if they are cross-border, look for an official traceability QR code. Don’t believe the anchors in the live broadcast room who say “take it for three months to lower blood pressure” or “improve insomnia and cure hair loss” - the new regulations have long made it clear that anchors who promote dietary supplements in live broadcasts must hold a public nutritionist or licensed physician qualification certificate. To put it bluntly, the regulatory adjustments in the past few years are squeezing the bubble in the industry. The past era of making quick money by relying on marketing and deception has passed. Whether it is brands or consumers, it is better to slowly adapt to such more transparent rules than to find reinforcements after suffering a loss.