The Publisher’s Desk: FDA Draft Guidance Still Threatens Health Freedom

As we’ve reported in past issues of this newsletter, health freedom is threatened by the FDA’s New Dietary Ingredient (NDI) draft guidance, which allows FDA to arbitrarily deny the sale of any supplement created (or modified) in the past seventeen years. The FDA’s comment period for responding to the draft guidance ended on December 2, 2011.

To recap, the NDI draft guidance threatens health freedom because it would cause many supplements to be taken off the market. It would allow the drug industry to adapt and patent them, and sell them back to consumers—by doctor’s prescription only—for 10 or 100 (or even more) times what people are paying now. Between 22,240 and 41,700 nutritional supplements would likely be removed from the market.

Acclaimed attorney Jonathan Emord filed comments on behalf of the Alliance for Natural Health—USA (ANH—USA), showing that the FDA violated the federal Administrative Procedure Act (APA), which states that if an agency’s action is legislative in nature, it’s rulemaking. Consequently, Emord argues that the FDA is acting illegally by circumventing the regulatory process by issuing a guidance instead of going through the rulemaking process, which is required when creating a new law. As a result, FDA’s actions leave interested parties little recourse within the regulatory system. It’s possible to challenge a rule in court, but not a guidance—which is very likely why FDA conveniently issued a guidance, instead of going through the rulemaking process, to avoid this very outcome.

A guidance is supposed to simply present the FDA’s interpretation of the rule. However, the NDI guidance goes well beyond an interpretation—it’s a legislative rule with legal implications such as altering and broadening the meaning of what qualifies as an NDI, and creates new—and very expensive—requirements to comply with the NDI notification process, counter to what is outlined in the Dietary Supplement Health and Education Act (DSHEA). Additionally, not fulfilling the NDI notification requirements outlined in the guidance ensures that the supplement will be considered adulterated and therefore illegal. This indicates there’s a clear, legally binding impact to the NDI guidance.

FDA has arbitrarily determined that supplement companies need to show at least “25 years of widespread use” in order it to meet the “history of safety” standard in NDI notification. In other words, only supplements on the market before October 1986 could be considered “safe.” Yet, the cutoff date for grandfathered ingredients assumed to be safe, according to DSHEA, is October 1994. Additionally, many of the provisions in the guidance are totally unrelated to safety and serve only to limit consumers’ access to nutritional supplements.

Due to the FDA’s violations, Emord and the ANH—USA have asked FDA in formal comments to withdraw the draft guidance at the earliest possible moment.

Now that the FDA’s comment period is closed, the agency is supposed to review the comments and prepare a final version of the guidance document—although they are under no legal obligation to do so. In fact, because it’s a guidance, they’re under no legal obligation even to consider public comments. And since this is presented as guidance and not formal rulemaking, the FDA is very likely to enforce the provisions in the draft guidance as though they were final, leaving affected parties limited legal recourse.

Emord is taking the FDA to task for not following the Administrative Procedure Act, which calls for a formal rulemaking procedure, and believes that by law they are required to do so. We will continue to update you on this important issue as it unfolds.