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FDA’s Evisceration of the Labeling Exemption in 21 USC 343-2

The FDA has rendered the labeling exemption in 21 USC 343-2 a dead letter through construction.  That provision of the Dietary Supplement Health and Education Act was inartfully written but nevertheless designed by Congress to liberate dietary supplement companies from the prohibition on nutrient-disease claims in 21 USC 343 when they supplied independent scientific literature along with products for sale.  FDA has rendered the section useless to the industry and has thereby robbed consumers of the helpful information they would otherwise have, disabling their exercise of informed choice.

In particular, Congress intended 21 USC 343-2 to permit a publication, reprinted in its entirety, to be exempt from the definition of labeling when given to customers in connection with the sale of dietary supplements on certain conditions.  Those conditions were that the content not be false or misleading; that the content not promote a particular manufacturer or brand of dietary supplement; that the content was displayed or presented with other subject matter to present a balanced view of the available scientific information; that the content, if displayed in an establishment, be physically separate from dietary supplements; and that dietary supplement in question not have appended to it any information.  There are definite First Amendment problems with restrictions contained within those conditions, but nevertheless this was to be an out for supplement companies to reach consumers with independent science on the therapeutic benefits of those dietary ingredients.

In the case of Wallach v. Crawford, the United States District Court for the Southern District of California issued a decision addressing the meaning of this section.  The case involved an effort by our client, American Longevity, to supply its customers with a complete copy of the PDR section on magnesium.  That section included reference to scientific findings on the therapeutic benefits of that ingredient.  We argued for American Longevity that dissemination of the PDR was protected by the First Amendment despite the fact that it did not satisfy the criteria in Section 343-2 and even if it met FDA’s view that it evinced evidence of an intent to sell magnesium as a drug.  The Department of Justice argued, on behalf of FDA, that in its view the content was not exempt from labeling but even if it were the FDA could prohibit dissemination of it nevertheless based on an inherent power of the FDA, derived from the statutory definition of a drug in 21 USC 321, to assay the intent to sell a drug based on external evidence associating a nutrient with a therapeutic function.  The Court did not reach the ultimate question of whether FDA’s use of the intended use doctrine violated the First Amendment and, thus, left it in place.  Wallach did not appeal that decision.

In short, FDA’s position then as now, is that even if all requirements of 21 USC 343-2 are met, and even if a publication is exempt from the definition of labeling, it can still examine that publication when disseminated by a dietary supplement company and determine if it evinces an intent on the part of the supplement company to sell its product as a drug.  Under this theory, whenever a dietary supplement company sends to customers a publication containing discussion of a dietary ingredient’s therapeutic effects or utility, FDA views that as evidence that the company intends to sell the dietary ingredient in question as a drug and declares the ingredient an unapproved new drug.  Consequently, by the artifice of construction, FDA has defeated the intent of Congress and rendered 21 USC 343-2 a dead letter.  The next time someone in the know tells you that it’s okay to send out a scientific article to customers of the dietary ingredient or supplement mentioned in the article, think again.  It may well be that FDA will deem your product a drug based on its intended use doctrine.

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