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Hi-Tech Pharmaceuticals Sues The FDA For "Bullying Tactics"
Date:11/18/2013

s, stating that it is "aware of nothing that establishes that a claim between the difference between the natural and synthetic version of the same form of a nutrient is not misleading." 62 Fed. Reg. 49826, 49841 (September 23, 1997). Denying the validity of synthetic botanical extracts would suggest FDA now views a material distinction between synthetic and natural versions of the identical ingredients. This approach towards DMAA is arbitrary and intellectually dishonest in light of the agency's consistent historical policy.

Several concrete examples illustrate that FDA recognizes the equivalence of naturally extracted sources and synthetic counterparts of dietary ingredients. FDA has affirmed as GRAS both natural and synthetic riboflavin, 21C.F.R. § 184.1695(a). vitamin A,  21C.F.R. § 184.1930(a).and vitamin D  21C.F.R. § 184.1950(a).  FDA approved the food additive Vitamin D3 in both natural and synthetic forms. 21C.F.R. § 172.380(a).  FDA has previously acknowledged the breadth of Section 201(ff)(1)(E) in the preamble to its regulation on requirements for nutrient content claims, health claims, and statements of nutritional support for dietary supplements. 62 Fed. Reg. 49859, 49860 (September 23, 1997).  There, the agency stated in a Federal Register preamble-which constitutes a formal agency advisory opinion- 21C.F.R. § 10.85(d)(1). That a substance such as CoQ10-which occurs naturally in tobacco, soybean oil, olive oil, and parsley is also commonly synthesized- falls within the broad range of dietary ingredients that Congress contemplated. Id.(quoting from the legislative history of "other nutritional substances"—a precursor to "dietary ingredients"—statements that numerous ingredients not traditionally or historically viewed as food substances would be included, such as primerose oil, black currant seed oil, etc.

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