dietary supplement regulations

The core logic of current global dietary supplement regulations lies in the differences in the attributes of such products by regulatory authorities - whether they are regulated as ordinary foods or as special foods close to drugs, which directly determines the huge differences in entry thresholds, publicity boundaries, and penalties. The current domestic rules such as the "Health Food Registration and Filing Management Measures" follow a middle path between the two extreme models in Europe and the United States. They not only leave sufficient market space for compliant companies, but also clearly draw the penalty red lines for false propaganda and illegal additions, two stubborn diseases in the industry.

Speaking of which, last year I met a customer who was selling cross-border fish oil, and I was particularly aware of the differences in regulations in different regions. His products have been sold in the United States for nearly ten years. According to the Dietary Supplement Health and Education Act (DSHEA) promulgated in 1994 in the United States, as long as the raw materials are recognized as safe, the efficacy can be declared by the company. Even if it is labeled as "reduce the risk of cardiovascular disease", no one will care. The FDA will only intervene in traceability after a safety incident occurs in the product, which is a typical "loose beforehand and strict afterward."

Supporters of this model are mostly small and medium-sized dietary supplement companies and free-market scholars. They believe that dietary supplements are essentially supplements to daily diet and are not used to treat diseases. There is no need to undergo several years of pre-approval like drugs. This not only raises the threshold for entrepreneurship, but also limits consumers’ options for accessing new ingredients. But the voice of opposition has always been loud, especially among experts in the field of public health. In the past few years, there have been several fatal cases of weight loss supplements containing banned stimulant ingredients in the U.S. market. This is a loophole under such loose supervision-many unknown small manufacturers dare to put them on the shelves by adding ingredients at will, and by the time the problem occurs, hundreds of thousands of bottles have been sold.

In stark contrast to the looseness of the United States, the EU is strict. The ingredients of all dietary supplements in the EU must first undergo a safety assessment by the European Food Safety Authority (EFSA), and efficacy claims must be officially certified by EFSA before they can be labeled. Even for a common ingredient like vitamin C, if you say it "can improve immunity," you must provide complete clinical data, otherwise it will be regarded as false advertising. Those who support this set of rules believe that consumer safety is the first priority, and strict access can completely keep messy products out of the market. However, the complaints from practitioners are also very real: it takes three to five years for a new ingredient to be approved, and by the time it is approved, the same products in the United States have been sold out and cannot keep up with the market.

Oh, by the way, there is another pitfall that many newcomers to the industry fall into. Many people think that imported dietary supplements sold by cross-border e-commerce companies only need to comply with the regulations of the country of origin. In fact, this is not the case at all - as long as they are sold to Chinese consumers, even if it is direct mail from overseas, the promotional caliber must comply with domestic regulatory requirements. Don't think that just hanging a cross-border brand can boast of "curing diseases". If consumers really complain, they will be punished according to the advertising law.

Turning our attention back to China, our regulatory logic actually has its own characteristics. It does not copy the model of any party, but follows the middle path of a dual-track system. Products using mature raw materials such as vitamins, minerals, and commonly used animal and plant extracts that have been included in the raw material catalog. If you go through the registration channel, you can get the qualification in a few weeks quickly. The threshold is very low. ； If new raw materials are used, or the claimed effects are not in the current list of 27 health-care functions, you have to go through the registration channel and undergo complete toxicological and functional experiments, which is equivalent to semi-pharmaceutical grade approval. The bottom line of safety is very tight. Last year, there was an Internet celebrity brand that made melatonin. It was fined 200,000 yuan because it added the words "treating insomnia" on its details page. It just stepped on the red line of "cannot claim therapeutic effects" - after all, the registered effect of melatonin is only "improving sleep", and it can't be missed by even one word.

This set of domestic rules is not without controversy. Most practitioners in the industry feel that the current raw material catalog and efficacy catalog are still too slow to update. Many probiotic strains and plant extracts that have been used in foreign countries for five or six years and whose safety has been fully verified have not been included in the permitted catalog, and innovative products are limited. ； People in the field of consumer protection feel that the current supervision is still too lax, especially because of repeated false propaganda in live broadcast rooms. Many anchors hold blue hat products and claim that they can lower blood sugar and cure arthritis. Ordinary consumers cannot tell the truth from the false, and the penalties must be increased.

In fact, to use an inappropriate analogy, dietary supplement regulations in various countries are like traffic regulations in different places: In the United States, if you say you can drive, you can get on the road, but if you really hit someone, you will be fined heavily.； In the European Union, you must first take a difficult driving license test, and you can only go on the road after passing the test. The accident rate is indeed low, but the cost of taking the driving license test is also terrifyingly high. ； Domestic rules are that ordinary scooters (conventional products with mature raw materials) can be driven with a simple registration certificate, while special vehicles (new raw materials, products with special effects) need a difficult registration certificate, and the entire road is monitored, and there are fines for crossing the line and speeding. This can be regarded as a balance between safety and efficiency.

Anyway, there is currently no perfect regulatory model in the world. The essence is to find a balance between consumer rights and industrial innovation. I recently read the draft for comments on the new regulations, and the update frequency of the raw material catalog has obviously become faster. Maybe in two or three years, many of the problems that everyone is complaining about will gradually be solved. Having been in this business for so long, my biggest feeling is that no matter how the regulations change, companies that make products honestly and do not touch the red lines of publicity will always go the furthest.