When evaluating whether an ingredient can be used in a dietary supplement, one must assess not only whether the ingredient is a new dietary ingredient (“NDI”), i.e., “a dietary ingredient that was not marketed in the United States before October 15, 1994,” 21 U.S.C. § 350b(d), but also whether prior to its sale as a dietary supplement it had first been approved or licensed as a drug or been the subject of publicized investigations as a drug.
Under the Dietary Supplement Health and Education Act, even if an ingredient is not a NDI and is thus “grandfathered,” it is unlawful to market as a supplement if, prior to being a supplement or food, it was: (1) approved as a new drug, certified as an antibiotic, or licensed as a biologic; or (2) authorized for investigation as a new drug, antibiotic, or biologic, and substantial investigations were instituted, and the existence of the investigations were made public. Id. at § 321(ff)(3)(A)-(B) (stating that the term “dietary supplement” does not include such articles).
The fate of pyridoxamine dihydrochloride (a form of Vitamin B6) is illustrative. In 2005, Biostratum, Inc., the manufacturer of the drug Pyridorin (pyridoxamine dihydrochloride), submitted a petition to FDA, asking the agency to prohibit the sale of dietary supplements containing the substance, which is a naturally-occurring form of vitamin B6 present in fish, milk and other foods. Biostratum argued that supplements containing pyridoxamine were unlawful because it filed an investigational new drug (“IND”) application with FDA in 1999 for use of the vitamin to slow or prevent the progression of kidney disease in diabetics, and there was no evidence that it was marketed as a dietary supplement or food prior to the investigations.
FDA agreed with Biostratum. In 2009, FDA took the extraordinary step of declaring that all products containing pyridoxamine are not dietary supplements. In reaching its decision, FDA rejected comments from industry that it was marketed as a dietary supplement prior to October 15, 1994. For example, FDA ignored comments stating that the ingredient was included on dietary supplement industry lists of grandfathered ingredients because the comments did not include documentation of marketing, such as catalogs, from the relevant time period.
In sum, dietary supplement companies must be able to substantiate that an ingredient was not only marketed as a dietary supplement prior to October 15, 1994, but that it also was not investigated or approved as a drug, antibiotic, or biologic prior to being marketed as a dietary supplement or food. If the ingredient was investigated or approved as a drug, antibiotic, or biologic prior to such marketing, a company’s only recourse is to file a citizen petition asking FDA to issue a regulation finding that the ingredient, when used as or in a dietary supplement, would be lawful. Id. That is an onerous and costly process to go through, especially since there is no issue as to the safety of this vitamin.