WASHINGTON, D.C.-- As reported in the last edition of HSR's Supplement Industry Insider, FDA has published an Advance Notice of Proposed Rulemaking ("ANPR") which seeks public comment on whether the agency should promulgate specific regulations governing current good manufacturing practices ("cGMP") for the dietary supplement industry. This is the most significant and important issue currently facing the industry. The outcome of this rulemaking may change not only the nature and scope of FDA's regulation of dietary supplements, but may also substantially alter the competitive balance within the industry itself.
The ANPR was issued at the request of several industry-affiliated groups, which presented FDA with a detailed draft of proposed regulations. As reprinted in the Federal Register, that draft of what supplement firms would have to comply with if the proposal were adopted by the FDA totaled over 19 columns of single spaced, 8-point type. Even more troubling, FDA announced that because the proposal did not go far enough, it is considering adding even more requirements to any possible cGMP regulations, to address at least nine additional areas which the agency believes it should regulate.
Both on its face, and in the historical context of FDA hostility to the dietary supplement industry, the current ANPR is particularly disturbing for several reasons.
First, the overwhelming majority of our industry takes special care to ensure that the supplements they manufacture and market are safe, pure, contain appropriate types and amounts of ingredients, and are manufactured in a clean and sanitary manner. However, when it comes to formal FDA regulation, the industry has only to look back on the long sad history of FDA efforts to stifle dietary supplements to realize that, notwithstanding passage of DSHEA, more government involvement is not in the public interest.
In that regard, it must be noted that there has been no convincing public case made for creating additional cGMP regulations applicable only to dietary supplements. Indeed, the FDA already has cGMP regulations for food, which are already applicable to dietary supplements. Those regulations specifically require that "all operations" in the manufacturing of any food must be "conducted in accordance with adequate sanitation principles," and that "appropriate quality control operations shall be employed to ensure that food is suitable for human consumption."
Existing regulations also require that "raw materials and other ingredients shall be inspected and segregated or otherwise handled as necessary to ascertain that they are clean and suitable for processing into food." Thus, any potential GMP issues for supplements are easily covered under those broad regulatory principles, and it seems quite unnecessary to re-invent the wheel in the excruciating detail set forth in the current proposal.
Nevertheless, under the approach proposed in the ANPR, rather than adopting reasonable, individualized procedures to assure cleanliness and product purity, small and medium size companies may be burdened with complying with every item on a detailed multi-page, government-mandated checklist, and if any item is out of compliance at the moment an FDA inspector arrives, the entire plant would technically be subject to enforcement action, and every product produced there could be deemed adulterated even if the product is in fact perfectly pure, clean, and safe. In other words, the more minor, technical, requirements there are, the more easily FDA can shut down a firm for a "violation" that has no real impact on product quality.
Second, the FDA has gone far beyond the "industry proposal," and has suggested that it will seek to regulate the labeling claims made for dietary supplements, as well as several other significant issues including mandatory pre-market safety research, adverse event reporting, and various additional recordkeeping requirements through the backdoor mechanism of cGMP regulations.
FDA acknowledges that even though under DSHEA, any supplement GMP regulations must be "modeled" upon existing food GMP regulations, the agency argues that the additional areas it seeks to regulate are fair game because the law "does not preclude FDA from adopting CGMP regulations for dietary supplements that have no counterpart" in the food CGMP regulations. In other words, FDA believes that as long as some of the supplement GMPs resemble food GMPs, it is OK if other parts are exactly like the more onerous drug GMP requirements.
FDA's continuing anti-supplement strategy is reflected in the statement in the ANPR that FDA believes that "CGMP is intended to ensure that. . .a food is safe for its intended use." This statement is a distortion, because food cGMP regulations are not meant to be a way to restrict the intended use for products, but rather are designed to ensure that food is manufactured and processed in such a way that it is suitable for human consumption i.e. it is not "unfit for food."
Unfortunately, the agency may seek to tie that mis-application of the food GMP concept to the DSHEA provision that a supplement is adulterated if it "presents a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in labeling." Thus, FDA may argue, a dietary supplement containing, for example, Melatonin, DHEA, Co-Q10, or even megadoses of vitamin C, is adulterated under the cGMP regulations, because without absolute proof that they are necessary as supplements, they cannot be deemed reasonably safe for the structure/function intended use reflected in the labeling.
And, of course, it would be the FDA that determines what a product's "intended use" is. When FDA interprets a supplement's labeling, it seems to always be able to "find" a drug or other unapproved claim as the intended use, even when such a use is nowhere discussed in any product labeling. Thus, with the proposed cGMP regulations, it may become a simple matter for FDA to force a product off the market on the theory that even if a claim complies with DSHEA's structure/function safe harbor, that structure/function use is not "safe" within the meaning of the GMP requirements.
Finally, when it comes to FDA and dietary supplements, everything boils down to politics in one form or another. In this case, FDA has pinned the dietary supplement industry into a very tight political and public relations corner. By proposing cGMP regulations that potentially include provisions that go beyond FDA's authority as delineated in DSHEA, FDA is daring the industry to say "no."
If the ANPR encounters strong opposition and there are many elements which deserve such strong opposition there are certain to be media reports claiming that dietary supplements are completely unregulated, and that the industry has opposed FDA's efforts to ensure that they are safe. This would be an utter distortion, but in the world of soundbites, that is the message the American public will get.
The challenge facing our industry now is to find a credible and effective way out of the potentially serious predicament created by the FDA's cGMP proposals. Comments in response to the ANPR are due at FDA no later than May 7, 1997.