Q: When is a food not a food? A: When the FDA twists an old law to its own ends. Action Alert!
According to the Food Drug and Cosmetics Act (FD&C), originally passed in 1938 and amended many times since, any “article (other than food) intended to affect the structure or any function of the body” is considered a drug.
In the FDA’s recent guidance on new drugs (INDs) that we’ve been telling you about, the agency has come to the rather bizarre conclusion that conventional foods (including medical foods) may only make structure/function claims under limited circumstances. Specifically, the structure/function claim must be related to the product’s “taste, aroma, or nutritive value.”
This tortured definition is presumably supposed to rein in food or medical food producers from talking about weight loss, for example, since such a claim would not be about taste, aroma, or nutritive value. The agency cites a thirty-year-old court case to defend itself from the valid charge that it is trying to legislate on its own without congressional approval.
We have discussed the importance of structure-function claims many times. They are one of the few and very important avenues by which the public can learn about the health benefits of foods.
That the FDA is particularly targeting weight loss, may be inferred from this passage in the guidance:
If an edible product that might otherwise be a conventional food is intended for a use other than providing taste, aroma, or nutritive value, such as blocking the absorption of carbohydrates in the gut, the product becomes a drug because the primary purpose of consuming it has changed. In other words, the product is no longer being consumed as a food—primarily for taste, aroma, or nutritive value—but used as a drug for some other physiological effect.
By way of further example, the FDA explains that a study of the effect of soy on bone metabolism would require the manufacturer to file an Independent New Drug (IND) application. This means that products such as coffee or prune juice may be studied for their impact on digestion, but in order to do so, an IND would now be required. In this way, soy, coffee beans, and prunes would magically be transformed into drugs.
As FDA Law Blog points out, the FDA’s reliance on the very narrow interpretation of the phrase “other than food” is in direct conflict with other case law—and the opinion of the Seventh Circuit Court:
Case law establishes that, in the view of the courts, a “food” may properly make any claim in labeling that is truthful and nonmisleading about a “physiological effect” of the food, including a physiological effect of a component of the food, on the structure or function of the human body, provided that the claim does not represent that the product is intended to cure, treat, mitigate, or prevent disease (which would create “drug” status for the product), and does not “characterize the relationship” between a “substance” and “disease,” “damage,” or “dysfunction” of the body (which would meet the definition of a “health claim” and create separate requirements).
In addition, Congress explicitly legislated a “food” exemption for structure/function claims for a reason. The law’s clear intention is that foods can legitimately make structure/function claims.
This strange interpretation in the IND guidance, combined with the provision in the guidance that we discussed previously—the one that requires companies to start the drug approval process if a nutrient is to be studied for its potential disease prevention or treatment, even if the food or supplement won’t make any related health claims or be marketed as a drug—will ensure an increase in INDs for food, dietary supplement, and medical food research.
INDs are wildly inappropriate for food and supplement research. They are costly (as we have mentioned before, the cost of an IND application is currently about $2.3 million, which then leads to billions more for approval). They’re also incredibly burdensome, requiring:
- A general investigational plan;
- Information and completed forms about the investigators;
- Study protocols;
- Chemistry, manufacturing, and controls (CMC) information about the drug substance and the drug product; and
- Animal pharmacological and toxicological studies and any prior human experience.
Much food and supplement research has been done by university labs. That would no longer be feasible if the FDA has its way.
Furthermore, as we have pointed out repeatedly, foods and supplements (unlike drugs) do not expose the public to the kind of risk that would justify such tight control and monitoring under an IND (e.g., submission of animal and toxicological studies to FDA). Foods and supplements are complex mixtures of many compounds which are impossible to characterize in the way FDA expects for an IND, unlike drug products that consist of a single active compound (and a few other well-characterized compounds).
Even more importantly, no one has ever alleged that food and nutrition research was posing any danger to patients or consumers—and yet this very research is now endangered by the FDA’s guidance. Remember, once an IND for a nutrient has been filed, it may preclude that ingredient from being used as a food or dietary supplement at a later stage.
We spoke with Matthew Vukovich, PhD, who chairs the Department of Health and Nutritional Sciences at South Dakota State University. He believes that INDs should not be required at all for food research. He says his department is delaying research while they try to seek clarification on the FDA’s requirements.
A number of researchers are trying to convince the FDA that the guidance needs to be changed. They too say it has severely hindered their ability to conduct food research.
It is bad enough that food and supplements, the cutting edge of health science, cannot make any medicinal claims. But for the FDA to try to stamp out research on food and supplements is an outrage.
Action Alert! If you have not done so already, please contact the FDA and tell them to stop trying to halt food and supplement research! Tell them—and your legislators—that food nutrition research has no part in the drug approval regime. Their guidance is stopping scientific research in its tracks, at a time when we desperately need more research, not less. Send your message today!