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Court Finds Against Hi-Tech Pharmaceuticals in DMAA Lawsuit: “[P]roducts . . . containing DMAA are adulterated”

Enforcement Report

By Rick Collins and David Torreblanca

On April 3, the United States District Court for the Northern District of Georgia granted the Food and Drug Administration’s (“FDA”) summary judgment motion and denied Hi-Tech Pharmaceuticals, Inc.’s (“Hi-Tech”) motion. This decision (temporarily) concludes the parties’ long-fought battle over the legal status of products containing 1,3 Dimethylamylamine, better known as DMAA.

Dietary Ingredient?

The parties’ opposing motions for summary judgment hinged on whether DMAA could be found in geraniums. If it is in geraniums, Hi-Tech argued, it is a “botanical” (or a constituent of a botanical) and a legal “dietary ingredient.” The government contended that geraniums do not make DMAA; DMAA is synthetic, not a “botanical,” and not a “dietary ingredient.” And since it is not generally recognized as safe, it is an unsafe food additive.

The first pages of the decision set the table for a Hi-Tech win. The court discards many of the government’s arguments, concluding that DMAA is very likely in geraniums—or, at least, that the government could not show DMAA is not in the plants. Contradicting FDA’s New Dietary Ingredient (“NDI”) draft guidance, the court even “credits Hi-Tech’s argument that a botanical can be synthesized in a laboratory without losing its status as a botanical,” thus qualifying as a “dietary ingredient.”

The court then turns the tables on Hi-Tech, explaining why it does not view DMAA as a “botanical” or “dietary ingredient.” The substance is found only in trace amounts in geraniums. The court says that while “botanicals” can be synthesized in a laboratory without losing their status as “dietary ingredients,”

it is inconceivable that in passing the DSHEA Congress intended for supplement manufacturers to take a chemical that heretofore had only been manufactured in a laboratory and to scour the globe in search of minuscule amounts of that chemical in obscure plants so that they could declare the substance a dietary ingredient under the statute. To hold otherwise would be to open the door to bogus claims that, for example, a given chemical had been detected in a fungus found only in a remote Tibetan river valley, and the FDA would be left to refute that claim—to prove a negative—which the instant case demonstrates is not easily done.

This Court thus concludes that in using the term botanical, Congress intended that there must be at least some history of the substance in question having been extracted in usable quantities from a plant or a plant-like organism, leading this Court to find that DMAA is not a botanical and thus not a dietary ingredient.

Since the court finds that DMAA is not a “botanical” and thus not a “dietary ingredient,” it then assesses whether it is generally recognized as safe. The court cites a Texas DMAA product liability case that discussed DMAA safety studies. The Texas court ruled “that the scientific literature on DMAA presents insufficient data to conclude that DMAA is safe or that DMAA causes harm.” Because there is no consensus among experts regarding DMAA’s safety, the court finds that DMAA is not generally recognized as safe. “Accordingly, products for human consumption containing DMAA are adulterated foods under the FDCA and subject to seizure . . . .”

Implications for Similar Substances?

What does this mean for other ingredients that are found in trace amounts in nature? In FDA’s NDI draft guidance, it writes that synthetic copies of botanicals are not “botanicals” (or “constituents” or “extracts” of “botanicals”) and not “dietary ingredients.” Therefore, a chemical’s existence in nature does not make a lab-created copy of that chemical into a “dietary ingredient.” However, this guidance is not law; it simply represents FDA’s current thinking on the topic.

The Hi-Tech court’s decision disagrees with FDA’s NDI draft guidance, writing “a botanical can be synthesized in a laboratory without losing its status” as a dietary ingredient. That is big news for industry. But not everything theoretically in a botanical is a “dietary ingredient.” The court seems to have introduced a test for synthetic, would-be botanical “dietary ingredients” that can be found in plants: Is a company synthesizing a constituent of a plant found in usable quantities in a food people eat, like resveratrol in grapes? If so, it is possibly a “dietary ingredient.” Or is it synthesizing a chemical, then “scour[ing] the globe” to find a plant that contains miniscule amounts of that chemical? These ingredients would not be “dietary ingredients.” Under this test, an ingredient like Beta-Methylphenethylamine (BMPEA) would probably not be a “dietary ingredient” even if it were found in Acacia rigidula, as some argue. While not controlling in other cases, this test may influence other courts, or even FDA.

What’s Next for DMAA?

PricePlow reports that Hi-Tech’s CEO plans to file a motion for reconsideration arguing the court should change its decision. Hi-Tech contends DMAA can be extracted from geraniums in usable quantities and that the parties did not have the opportunity to brief the definition of “botanicals.” If that motion is unsuccessful, Hi-Tech plans to appeal the decision to the United States Court of Appeals for the Eleventh Circuit. This case may not truly end for several more years.

In the meantime, FDA can still pursue other companies that sell DMAA products. Aside from FDA, you can bet that class action attorneys are already drafting complaints to file (or threaten to file) against those selling DMAA. These complaints will quote the Hi-Tech decision and allege that DMAA-sellers misled consumers by misrepresenting DMAA as a legal dietary ingredient.

Stay tuned for updates!

In today’s regulatory climate, where FDA, FTC, state attorneys general, industry self-regulatory organizations, class action lawyers, and even individual U.S. Senators are leading a patchwork of crusades against dietary supplement and cosmetics companies, it is vital to keep up to date with the latest enforcement efforts and trends. We regularly send out emails summarizing the latest enforcement actions (opt in; we never share our subscription list, and you can opt out at any time at the bottom of each email). Please share them! Learning from others’ mistakes is cheaper than learning firsthand what kinds of practices and violations lead to enforcement.

If you have a dietary supplement or cosmetics company and have any questions about your responsibilities under the law, including ingredient legality, label claims, labeling requirements, advertising review, CGMPs, or anything else, give us a call anytime at 516-294-0300.

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