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Cheerios®: breakfast cereal or drug?

Cheerios® – venerable breakfast cereal or…drug? Last month the FDA issued a warning letter to General Mills CEO Ken Powell, informing him that the cholesterol-lowering claims on the Cheerios label transformed it from food product to unapproved drug.  The Food and Drug Administration Modernization Act of 1997 allows for certain authoritative health claims to be made on food products (see FDA Guidance). The exact wording of the claim and a description of the scientific evidence upon which the claim is based must be approved by the FDA before the claim appears on a marketed product, and such claims may not attribute any degree of risk reduction. The Cheerios label does contain an authorized health claim about soluble fiber/coronary heart disease (21 CFR 101.81). However, the Cheerios label also contains the statement, “You can lower your cholesterol 4% in 6 weeks.” This claim of a degree of risk reduction was a major factor in the FDA’s decision to classify Cheerios with the cholesterol-lowering claim in its label as a drug.

This incident brought to mind the situation of dietary supplements. In contrast to foods, the Dietary Supplement Health and Education Act of 1994 (DSHEA) allows certain types of claims to be made about the uses of dietary supplements without prior review of the statement (65 FR 999, 6 January 1999). These statements are generally referred to as “structure/function claims” and include, among other things, statements that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function [21 CFR 101).  DSHEA also amended the Federal Food, Drug, and Cosmetics Act to reflect the fact that dietary supplements that contain such statements are not to be considered as drugs. But cross the line and make a disease-related claim about a dietary supplement and the supplement is then considered to be a drug.

So what happens when a company wants to combine a dietary supplement with an over-the-counter (OTC) or Rx drug? In October 2001, warning letters were issued to 2 pharmaceutical companies who tried to market products that combined acetaminophen (an OTC drug) with dietary supplements. It has been legal to market acetaminophen without an NDA since the publication of a 1977 report that recommended acetaminophen be considered GRASE (42 FR 35346). As dietary supplements, melatonin and glucosamine could also be legally marketed without prior approval under DHSEA. However, under section 403 dietary supplement claims “may not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of disease” except for certain classical nutrient deficiency diseases. In addition, dietary supplement products may not contain any ingredients that are drugs, unless the drug was marketed as a dietary supplement before it was approved as a drug. The presence of an approved drug (acetaminophen) in the finished product and the disease claims for the supplement portions of these products caused them to be ruled unapproved drugs.

On May 30, 2000, the FDA issued letters about the regulatory status of products that combine an over-the-counter drug with a dietary supplement. In these letters, the FDA stated, “The agency must determine under what conditions these combination products can be marketed in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by DSHEA. More specifically, the agency must determine what regulatory standards are appropriate, including, but not limited to, what safety and effectiveness standards will apply and how such products will be labeled.” The FDA also asked firms to refrain from marketing products that combine both drug and dietary supplement ingredients, except for products marketed under an approved NDA, “until the agency has carefully considered these issues”, and stated that “The number of inquiries we have received on this subject has made resolution of these issues a priority at the agency [emphasis added]. We will be providing additional information as we develop our policy in this area.” However, nearly a decade later, regulatory standards have still not been determined. The issue continues to be a problem, as evidenced by a similar warning letter that was recently issued to the manufacturer of BAYER WOMEN’S Low Dose Aspirin + CALCIUM (27 October 2008).