Q: Why is the Dietary Supplement Health and Education Act of 1994 so important?
A: DSHEA created a specific legal category and a framework for regulating dietary supplements. Until that time, there was neither. The industry was tiny in comparison to what it is today, and moribund. DSHEA defined the parameters for both the industry and the Food and Drug Administrationâthe FDA was no longer free to make up rules as it went along. Very importantly, it opened up the number of [product] offerings to consumers and created for the first time the opportunity to present to the public a previously forbidden topic: nutritional biochemistry.
Q: What was your role and your companyâs role in helping get DSHEA passed?
A: I was relentless. I put together the first-ever meeting between the industry and the FDA, and I walked both houses of Congress three times in support of what became DSHEA. It was exhausting. Jarrow Formulas also sent out a continuous stream of messages to retailersâespecially concerning my idea about forming a review panelâasking them to get petition signatures, and then I forwarded copies of the signatures to numerous offices. The review panel gave the original outline to the FDA for what it was to do. I think it was instrumental to the billâs passage. Not the âmake or break,â but fairly important.
Q: Is DSHEA currently under threat?
A: Absolutely. There are two current threats. The first is the General Accounting Officeâs Report on Supplement Regulation [which recommends the FDA take more action to improve supplements oversight and consumer understanding]. Jarrow Formulas intends to take that report apart and make our findings public.
The other threat is Senate Bill 510 [the FDA Food Safety Modernization Act]. It has a frightening provision: recommendations to harmonize requirements under the Codex Alimentarius. This means that supplements, which are considered food in Europe, would become subject to overregulation. This will affect farmers, food processors, definitions of foods, supplements, what can be sold as supplements, the allowed dosages and claims. This must be stopped. At a minimum, supplements must be specifically exempted from this provision, but I donât trust that to be sufficient. The provision should be dropped from the bill. Period. Sen. Tom Harkin, D-Iowa, chairman of the Committee on Health, Education, Labor and Pensions, needs to be lobbied, and so does everyoneâs Congress member and senator. The usual. Here we go again. Frankly, Iâm sick of it, but the alternative will be disastrous. Iâve never cried wolf. This is a real threat.
There are two other areas where the FDA is enforcing DSHEA in bad faith. The first has to do with the failure to approve the overwhelming majority of new dietary ingredient applications. The FDA is applying drug standards even when companies have applied for NDIs for formulations using well-established ingredients.
The second area has to do with the FDA applying a somewhat arcane provision of DSHEAâthat an ingredient that has been previously the subject of a new drug application, and subjected to a substantial amount of research to that end, cannot be permitted as a dietary supplement. The FDA is taking a strict view, and I was told this by one of the guys in charge of the issue for the agency that any NDA whatsoever, no matter how old or how little work was actually done, is deemed to be a bar to the ingredient ever being a supplement. The agencyâs bad faith is costing our industry many millions, and the consumer is being denied the health benefits of these ingredients. So far, no one is willing to take this on.
Q: What would our industry look like without DSHEA?
A: We would be finished. Congress would end up passing legislation to require us to have premarketing licensure from the FDA for every single productâformula or label changes. It would be the end of most companies and many stores and other businesses.
Q: What can retailers do to protect DSHEA?
A: In the present, they need to start educating their customers about the pending Codex harmonization and get them to contact their legislators to oppose it. And to contact the offices of Senators Harkin and [Orrin Hatch, R-Utah], who have been our champions. In the long term, they have to be careful about the products they carryâthat they are well made and safe.