FDA Guidelines a Perversion of Congressional Intent
July 12, 2011
The FDA is trying to turn a simple notification system for new supplements into a totally arbitrary approval system. Let’s tell the FDA that supplements are not drugs and ask Congress for help!
Last week we told you about FDA’s draft guidance on New Dietary Ingredients, which allows FDA to arbitrarily deny the sale of any supplement created (or said to be created) in the past seventeen years! Already this has become an explosive issue, with media attention from numerous quarters. The FDA will no doubt call everything that is being said “an overreaction.” We expect them to say, “It’s only draft guidance! It’s not legally binding!” But don’t be fooled. Just because the agency is calling it “draft guidance” doesn’t mean this thing doesn’t have teeth.
If you’re a supplement manufacturer or distributor or possibly even a health food store, and you don’t file a NDI “notification” (actually a request for approval) for each ingredient in each product developed since 1994 in just the way prescribed by the FDA, and the court later decides the FDA is right, then you are guilty of product “adulteration,” which is punishable by jail.
The FDA will also say that they have no intention of destroying the supplement market. This is true for now. The FDA knows they can’t just disapprove all supplements developed or modified since 1994, at least not all at once. But they can double or triple the price of supplements and they can gradually disapprove more and more of them over time until there is little left but drugs. Those of us opposing this new FDA guidance are not using scare tactics. The threat to supplements is real and urgent. This has to be stopped now, or over a long period of time supplements as we know them may disappear.
The Dietary Supplement Health and Education Act of 1994 (DSHEA) was landmark legislation. The NDI notification system that DSHEA outlined was supposed to be about notification, plain and simple, with only occasional response from the FDA. In fact, before this draft guidance was published, Sens. Tom Harkin and Orrin Hatch—the two principal authors of DSHEA seventeen years earlier—wrote to FDA Commissioner Margaret Hamburg, MD, to underscore their expectation that the guidance be consistent with the intentions of DSHEA. “In DSHEA,” they wrote, “Congress made clear that consumers should continue to have access to dietary supplements that meet the law’s definition [and] should also refrain from erecting barriers that will inhibit or needlessly delay consumer access to safe products.”
To quote DSHEA itself: “Congress finds that:
- the Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers;
- dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare;
- and legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness.”
In nearly every provision of the draft guidance, the FDA simply disregards clear and compelling evidence of the law’s intent.
FDA: We Will Decide What Supplements Can Be Sold
By turning what was meant to be a pre-market notification system into a pre-approval system, the FDA becomes the ultimate arbiter of what dietary supplements will and will not be available.
The FDA does this by simply not “filing” (which means accepting) any NDI notifications they don’t like. It may be because the notification does not meet rigid FDA specifications. Or it may be for any reason, however arbitrary.
ANH-USA has gone through the NDI notifications publically available, and we can confirm that a large number of NDI notifications, we think a majority, have been rejected—and this was before the new guidance spelled everything out, complete with handy flowcharts. Now it will be even harder for an NDI to be accepted, greatly diminishing consumer access to dietary supplements. The FDA even wants human trials, even if a supplement already exists and has just been slightly modified.
If the FDA does not “file” (approve) the NDI notification, and a supplement manufacturer, distributor, or possibly health food store still markets the supplement, the FDA considers the supplement an adulterated product. This makes the manufacturer or distributor vulnerable to FDA enforcement—including seizure of their products, injunctions, fines, and jail.
DSHEA: Supplements Are Not Drugs or Food Additives
Built into the Federal Food, Drug, and Cosmetic Act (FD&C) are pre-approval food additive provisions. But under DSHEA, dietary ingredients were intentionally exempt from those food additive provisions, to ensure that the FDA would not ban new supplement dietary ingredients as illegal unapproved food additives.
Moreover, in the Congressional Record of August 13, 1994, the DSHEA authors explain the purpose of DSHEA is to “clarify that dietary supplements are not drugs or food additives” and that “regulations relating to food additives are not applicable to dietary supplements and their ingredients used for food additive purposes.” Since dietary supplements are also specifically not drugs, it is counter to congressional intent to push the approval standard in the NDI notification closer to the pharmaceutical standard.
According to DSHEA, all dietary ingredients on the market before 1994 are grandfathered in—that is, they are not considered new supplements (NDIs), and are therefore not subject to the NDI notification. But FDA interprets “chemical alteration” very broadly, and so the agency is demanding an NDI notification for every reformulation and every new combination of any dietary ingredient, even those marketed before 1994. This FDA interpretation essentially ensures that many—and eventually, most—dietary ingredients currently on the market will be considered an NDI, subject to notification, and therefore to disapproval.
This, too, is clearly counter to congressional intent. It sets up supplement manufacturers to fail, and will turn most of them into alleged criminals if they persist in selling supplements not specifically approved by the FDA. At the very least it will cause supplement costs to soar. Supplement costs are high enough already—too high for many Americans to buy them, no matter how much they benefit health and thus reduce costs over the long run.
The 75-Day Waiting Period
DSHEA says that a manufacturer or distributor has to submit a notification 75 days before it is introduced on the market. It makes no mention of any requirement for FDA to respond, because notification was assumed to be a routine event. FDA then takes that requirement and twists it to say that a supplement manufacturer must wait 75 days after FDA files (accepts) the notification before the product can be marketed. And depending on how much additional information the FDA requires, it can be a while before the FDA files or, as noted above, FDA may choose not to file the notification at all—ever. The product is then in limbo and can only be sold at great legal risk.
And who must submit the NDI notification? “Either the manufacturer or distributor of a dietary supplement that contains a NDI, or the manufacturer or distributor of the NDI.” But what, in FDA-speak, does “distributor” mean? Could it include health food stores? If so, this puts an absurd burden on mom and pop stores trying to offer healthy alternatives to the public—especially if no one else filed a NDI in the supply chain. It would certainly seem to apply to larger companies, like Whole Foods, who distribute supplements under their own label.
The FDA should limit the NDI notification requirement to ingredient or supplement manufacturers, not sellers. Putting that burden on sellers—making them file a notification if they learn that their supplier hasn’t done so—essentially turns them into FDA enforcers. We think that smacks of police state tactics. Make everybody turn everybody else in or be arrested yourself.
The Question of Synthetics
Synthetic vitamins and supplements still have to comply with the NDI notification process if they were not a dietary supplement ingredient before 1994. The FD&C Act repeatedly includes synthetic vitamins and minerals with natural ones in its definition, and NDI notifications for synthetic vitamins and minerals have been filed in the past.
However, the draft guidance makes clear that the FDA does not consider synthetic botanicals to be NDIs at all: “A synthetic copy of a constituent of a botanical was never part of the botanical and thus cannot be a ‘constituent’ of a botanical that qualifies as a dietary ingredient. Similarly, a synthetic version of a botanical extract is not an ‘extract’ of a botanical…because it was not actually extracted from the botanical.”
What does all this gobbledygook mean? Bear with us, because it is important. It means that while new formulations of both natural and synthetic minerals are required to make NDI “notifications,” synthetic molecules derived from plants are not included. Why? Because these molecules might easily be made into a new drug by a pharmaceutical company.
The FDA is saying that synthetic botanicals can never be sold as a supplement and must always be treated as drugs. No surprise, of course. The FDA, if it had the power, would treat everything as a drug and require the full drug approval process, no matter what it does for cost or availability.
Both the FDA proposed NDI guidance and the dangerous Durbin bill (see our new article on Durbin in this issue) seek to give the FDA broad new authority to disapprove supplements or supplement ingredients on totally arbitrary grounds, with no rules or standards. If allowed to stand, over time this will drastically reduce the number of supplements and supplement potencies, raise prices substantially, injure our ability to take care of our health, raise healthcare costs, stifle supplement innovation, and cost millions of jobs in the supplement industry.