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

vidence regarding DMAA and its safety."   Hi-Tech says it wants the "FDA's campaign of intimidation" stopped by the court, and that "if the agency has scientific evidence which brings the safety of DMAA into question, that it disclose same and engage in the formal rule making process to ban the ingredient."

The FDA has rested its very, very shaky case on a false premise, or misguided hope, that DMAA is not found in geranium since they first sent out the original warning letters in April 2012, and that synthetic analogues of naturally occurring consumables would never qualify as a dietary ingredient. This willful misinterpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) comes directly from the FDA's NDI Draft Guidance.

For the FDA to assert that no synthesized natural compound could ever be a dietary supplement is tantamount to saying that the vast majority of all dietary supplement products on the market today are adulterated. FDA has a long history of recognizing that synthetic ingredients identical to natural ingredients should be treated the same. FDA's nutritional labeling regulation states that a food is deemed misbranded if its labeling states or implies "That a natural vitamin in food is superior to an added or synthetic vitamin. 21C.F.R. § 101.9(k)(4). This prohibition dates back to the late 1960s, when the agency vigorously defended its position on this issue during two years of public hearings on special dietary food regulations. These hearings took place between 1968 and 1970. See 38 Fed. Reg. 2143,2147, 2150 (January 19,1973). At the end of the rulemaking process, FDA concluded that "There is no nutritional difference between a vitamin provided by a synthetic source and the same vitamin provided by a natural source…."

As recently as the late 1990s, FDA reaffirmed the validity of the prohibition on distinguishing between natural and synthetic ingredient
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SOURCE Hi-Tech Pharmaceuticals, Inc.
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