Understanding the Impact of FDAAA 912

Everyone working in the health care industry has heard the phrase “small changes, big results.” Normally, this phrase refers to small lifestyle changes that result in substantial improvements to an individual’s overall health and wellness. But what happens when a small change doesn’t have a positive impact but, rather, has the potential to yield negative results?

For the dietary supplement industry, this could be the case with the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 912. This relatively short provision, hardly noticed when the legislation was enacted, has the potential to have a huge impact on the future of ingredient innovation for functional foods and dietary supplements. According to Section 912, FDA is instructed to prohibit a food from entering the market if it “contains an approved drug or biological product for which substantial clinical investigations have been instituted and the existence of those clinical investigations have been made public, unless the food was marketed first.”

If this provision sounds familiar, you’re right—this provision regarding “food” is similar to Section 201(ff) of the Dietary Supplement Health & Education Act (DSHEA) that applies only to dietary supplements, and was the basis for the decision to prevent Pharmanex from marketing Cholestin®, containing red yeast rice to lower cholesterol, because lovastatin was already on the market as a drug. But this new provision has a few important distinctions. First, the FDAAA provision applies to all “food”—meaning both conventional foods and dietary supplements. In reading the provision, it seems the intended result was to assure that ingredients prohibited from use in dietary supplements would also be prohibited from use in functional foods. Second, the supplement provision of DSHEA stipulates that the article must already be “authorized for investigation as a drug, antibiotic or biologic” to remove it from use in supplements, but that requirement is missing from FDAAA, Section 912, with respect to food.

So what does this mean? At this point, it’s unclear; the only thing that is clear is that the provision raises a lot more questions than it answers. Why was the “authorized for investigation” language that appears in Section 201 for supplements omitted from the FDAAA provision for food? What constitutes a “substantial clinical investigation”—a single published clinical trial, several clinical trials—that could effectively remove an ingredient from the food marketplace? What if a pharmaceutical company were to do a single, small animal trial on a newly discovered natural ingredient and then charge higher prices for the synthetic version of the ingredient by marketing it as a drug—would that close the market to food ingredient suppliers because the ingredient would fall under an article approved as a new drug? Since supplements are a category of “food,” does this new provision override the language of DSHEA?

Under the FDAAA provision, the previously flexible, shaded line that distinguished foods and drugs could become much more strict, further segregating the regulatory categories, but also providing some amount of “first-to-market” protection for companies that invest heavily in research and development of new products. Given the recent increased interest of manufacturers of food and pharmaceuticals to cross-market, develop combination products and play in one another’s sandbox, not to mention consumers’ interest in functional foods that contain added substances for additional health benefit, this tiny, vague provision could have significant consequences for both industries.

The dietary supplement industry specifically must wonder whether the newer FDAAA provision “trumps” or replaces the DSHEA provision. One generally recognized rule of statutory interpretation suggests the most recent act by Congress always supersedes the older provision. Given that FDAAA is the later enactment, and dietary supplements are a category of “food,” one might easily assume Section 912 governs, even for supplements, and it essentially removed the “authorized for investigation” requirement from the law. Yet, one could also argue that, because DSHEA’s Section 201 is specific to dietary supplements and Congress chose not to expressly repeal it, that it would overrule the more general provision of FDAAA, at least for dietary supplements. FDA is asking the industry what it thinks the new provision means, but the courts are likely to be the final arbiter.

For now, these are questions that the food and pharmaceutical industries, as well as FDA, need to grapple with. The food and supplement industries will need to aggressively protect their “turf” or lose it to pharmaceutical ingredients. Only time will tell whether this small change will yield big results and whether it will favor dietary supplements or stifle innovation in the industry.

Steve Mister is the president and CEO of the Council for Responsible Nutrition (CRNusa.org), a Washington, DC-based trade association representing dietary supplement industry ingredient suppliers and manufacturers.