ATLANTA, Nov. 18, 2013 /PRNewswire/ -- Hi-Tech Pharmaceuticals sued the FDA
November 5th, 2013 in Federal Court- Case 1:13-cv-01747, claiming the agency
bypassed standard rule-making procedures in favor of a bullying campaign to try
to force companies to destroy their products containing 1,3 dimethylamylamine,
or DMAA. "DMAA has existed in the food supply for many years," the complaint
states. "Hi-Tech has sold over a million bottles of dietary supplement products
containing this ingredient without any adverse event reports."
Hi-Tech calls DMAA a natural constituent of the geranium plant. It claims that
geraniums are used in salads and its oil as a flavoring. "No less than four
published, peer-reviewed scientific studies have confirmed the presence of DMAA
in the geranium plant. Large, established reputable laboratories such as Cantox
Health Sciences International have confirmed the presence of DMAA in the
geranium plant," the complaint states.
Hi-Tech claims the FDA's efforts to eradicate DMAA from the market exceeds its
authority and violates the Administrative Procedures Act. "Under the pretext
that DMAA-containing products pose a danger to consumers, the FDA has engaged in
a campaign of intimidation against dietary supplement companies like Hi-Tech who
include this ingredient in their products," Hi-Tech says in its lawsuit. "For
some companies this has taken the form of warning letters and pressure by the
FDA to remove and destroy DMAA containing products. In the case of Hi-Tech, the
FDA has issued an administrative detention order against numerous proprietary
dietary supplement products without notice, essentially removing millions of
dollars in goods from the marketplace."
Hi-Tech adds: "By its own admission, the FDA has declined to engage in the rule
making process necessary to formally ban DMAA. Thus there has been no public
discussion or comment regarding the scientific evidence 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 ingredients, 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.
Hi-Tech is determined to force FDA to follow the law and stop its "Bullying
Tactics". If FDA is allowed to run amok and continue to "Bully" ingredients that
they do not like off the market, then the dietary supplement industry will cease
to be able to give consumers ingredients they desire, such as DMAA, that has
been proven safe and effective.
CONTACT: Jared Wheat, 888-855-7919 x301
SOURCE Hi-Tech Pharmaceuticals, Inc.