The impact of the U.S. Dietary Supplement Health Education Act

The U.S. Congress passed the "Dietary Supplements" Health and Education Act in 1994, which immediately set off a global craze for herbal medicine and "back to nature." Sales in the U.S. "dietary supplement" industry have grown by 3-7% annually since 2000.

The industry takes charge of planning and promotes legislation

What is little known is that DSHEA legislation was not promoted by the U.S. Federal Food and Drug Administration (FDA). On the contrary, the entire bill was handled by the US health food industry from drafting to congressional lobbying and ultimately to the swift and successful legislation.

The U.S. health food and herbal industry is originally a fragmented and weak industry. Since American drug development embarked on the path of chemical drugs at the end of the 19th century and formalized this approach, natural drugs have gradually been marginalized and faced elimination. It seemed at that time that it was only a matter of time before the entire industry declined. But I never expected that a reversal of history would actually enable this industry to "survive from desperate situations" and flourish.

In the 1990s, some "adverse reactions" of chemical drugs in the United States gradually attracted attention, and people turned to milder "health foods". At that time, there were almost no regulations on the so-called "health food", and the definition was not clear. The exaggerated efficacy of the products was close to the efficacy claimed by drugs. As a result, the market has become chaotic and consumers are at a loss as to what to do. Therefore, society (especially the American pharmaceutical industry) has requested the FDA to vigorously rectify and regulate the industry.

At that time, the FDA intended to include "health food" in the category of "additives" for regulation. However, this undisclosed intention was leaked, and the US health food industry was in an uproar and opposed it. The industry generally believes that once "health food" is included in "additives", it will declare the death of the industry, because the application threshold for "additives" is high, far exceedingGenerally, health food companies cannot afford it, making it difficult to develop and freely purchase products that are originally considered relatively safe. This is inconsistent with the concept of the American free market.

In order to "defend" the survival of the health food industry, the entire industry, centered in Utah, commissioned capable lawyers to draft a bill to include "health food," herbal products, and various types of "oral products" into a broad definition. of “dietary supplements”* in an effort to reduce government regulation by positioning the entire category as a “food”. On the other hand, the industry launched a grand publicity campaign with the theme of "protecting consumers' freedom of choice" and used TV advertisements to accuse the government of improperly suppressing safe "health foods".

It just so happened that at that time, many important members of Congress were facing a new round of elections in which the outcome was unpredictable. As a result, the Republican and Democratic parties reached an agreement and passed DSHEA overnight without going through the normal procedures of committee review. The FDA was caught off guard, got a slap in the face, and is still very upset. Therefore, to this day, the FDA has been criticized for its poor enforcement of DSHEA.

Win the “right to choose” but lose the “right to know”

The experience of DSHEA being passed “accidentally” and its subsequent far-reaching impact on the world are worth pondering. The FDA was complacent at the time, looked down upon its stakeholders, and coupled with its black-box operations, caused a strong backlash from the industry and consumers. It happened to coincide with the political ecology of the general election, and the entire army was wiped out. Looking at it today, assuming that the FDA successfully positioned "health food" as "additive" on that day, I believe that the global "health food" industry may have shrunk, and herbal products have also suffered, let alone the "internationalization of traditional Chinese medicine" that the Chinese people hope for. ". On the contrary, if the FDA is willing to be flexible and work with the "health food" industry to discuss a reasonable regulatory system, the situation where both parties are in a dilemma today may not occur.

On the other hand, the industry expeditiously positioned the generalized "dietary supplements" as "food". Although it achieved the purpose of weakening government regulations, "dietary supplements" basically did not need to undergo strict approval before entering the market. The market has promoted the development of the market, but lax regulation has also caused a lot of abuses, which can easily be taken advantage of by unscrupulous people.

In addition, since "dietary supplements" are "foods", they can only provide nutritional information, but the correct information on their health care functions cannot be directly, openly and completely conveyed to consumers. Because of this, the latter often have no choice but to rely on "hearsay" and oral explanations from pyramid schemes to understand products, causing the "health food" industry to fall into a self-imposed trap in publicity and introduction, stifling the space for the development of excellent products. , and at the same time lead to the proliferation of fake products.

In general, although the industry and the public have won the "right to choose", they have lost the "right to know", which is contrary to the original intention of the legislation. It also makes the development of "dietary supplements" reach a certain point and enters an alley, making it difficult to Move forward. Since the authorities are lax in regulating "in accordance with the law", people are naturally wary of "dietary supplements", which is always inconsistent with smart business practices.

It can be seen from the experience of DSHEA legislation that although loose legislation has brought about 20 years of industry prosperity, the gap between government and business has not been eliminated yet. In the long run, incomprehensible government and disharmony between people are an unsustainable model, and the entire industry is showing signs of deterioration. Coupled with the fact that the approval systems adopted by Canada and the European Union have achieved certain successes as a comparison, DSHEA's lax regulations will inevitably be questioned.

"Dietary supplements" are narrowly defined as some nutrients, such as vitamins, that are lacking in daily food.

Conclusion

The journal cited at the beginning of this article has “Considerations in a Post-DSHEA World” as its headline issue in the same issue.Consulting industry elites, this can be said to be a warning for the "dietary supplement" industry. As long as there is a slight serious accident, opponents of DSHEA will definitely seize the opportunity to use all their strength to revise this bill. If such a day comes, I hope that all stakeholders will rationally absorb the opinions of all parties, balance the interests of all parties, and make reforms with reference to facts, science, historical traditions, and the experience of other countries, so that products can truly provide consumers with The clear benefits have opened a constructive new page for the "health food" industry.