Section 912 of the FDAAA could produce headaches for health and supplement claims

There has been considerable speculation about the potential fallout from Section 912 of the newly passed FDA Additives Amendment as it pertains to human food.  At first glance, §912 appears to be no more than a formalization of a “rule of thumb” enforced in food approvals for many years; that is, the use of a drug in a food (or a cosmetic, for that matter) was considered a trivial use and prohibited. For example, while addition of antibiotics to meat or underarm deodorants may provide for longer shelf life in the former and greater efficacy in the latter, the addition of the antibiotic was considered a trivial use and may contribute to antibiotic resistance.  In addition to antibiotics, other drugs are forbidden as well, because the intention of food is to nourish, not medicate, the consumer.  There are always exceptions to the rule, and an exception here is a drug called Cytellin®, the primary constituent of which was b-sitosterol, which blocks cholesterol absorption[1] and was marketed from 1954 to 1982.  b-Sitosterol, along with other phytosterols, are now added to margarine and marketed for essentially the same purpose.

A second look at the exact language of §912, reveals some wiggle room for interpretation by FDA.  That is, while there is a reference to approved drugs and biological products (D&BP), there is also an “or” which indicates the law is also referring to D&BP which have not been approved (i.e., approved by FDA).  Therefore, D&BP have been reduced to a generic term akin to the term “article” (used in DSHEA), to indicate any substance for which substantial clinical investigations have been undertaken.  The key paragraph is as follows:

Section 912(a) prohibits the sale] of any food to which has been added a[n approved] drug …, a biological product…, or a drug or a biological product for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, unless–

Therefore, if “drug or biological product” is interpreted in a generic sense, this has the effect of not only codifying the old rubric, but casts a wider net to capture any substance for which a clinical investigation has been undertaken.  This would have a chilling effect on conduct of any studies in pursuit of a claim.  For example, FDA mandates that any substance submitted for a health claim must have substantive (e.g., double-blind, placebo controlled) interventional studies demonstrating efficacy.  Further, these studies are made public during the FDA vetting process. Therefore, in order to meet FDA’s requirement for a health claim, the law is violated.  Additionally, there is no room for exemption in the law; there is an exception where the Secretary can grant a waiver through regulation, but this is only if the substance enhances the safety of the food, not for a health claim.

Strict implementation of the law could have even more insidious effects; for example, FDA may demand clinical studies be conducted for fiber (for tolerance). Other examples include clinical studies conducted for polydextrose, Olestra® and aspartame and, under §912, these substances would not be permitted for addition to food.  Lastly, FDA regards dietary supplements as “foods”, therefore any clinical work for claim substantiation for a structure function claim, would designate that ingredient as ineligible for addition to the food (i.e., the supplement).  With apologies to the late Joseph Heller, §912 may have the distinction of being the mother of all Catch-22’s and manufacturers would be the victims of unintended consequences.

Reference

[1] http://www.fda.gov/ohrms/DOCKETS/DOCKETS/95s0316/95s-0316-rpt000343-039-appx-E-Ref-27-GRAS-vol268.pdf (site accessed 20Aug08)