FDA prevails over Hi-Tech on DMAA, but ruling could open door on synthetic botanicals
The Food and Drug Administration has vigorously moved to remove all of the products containing DMAA, a stimulant-like chemical that Hi-Tech claimed can be found in geranium, from the market following safety concerns. In 2013 two soldiers died after exercising and having ingested products containing DMAA. In addition to the safety concerns, FDA had raised questions about the provenance of DMAA, whether it was actually found in geranium or whether that connection was a smokescreen to provide cover for a wholly synthetic ingredient. The agency also opined that DMAA would in any case be a New Dietary Ingredient (NDI) for which no notification was on file. FDA has issued warning letters to companies over the use of the ingredient and has seized products, including a high profile instance in which products were seized from GNC warehouses.
FDA had already seized products from Hi-Tech that contained DMAA, and the company sued to have that action dismissed. In the meantime, as the case wound its way through the courts for the past several years, Hi-Tech has been free to operate and was offering DMAA products for sale as late as this morning.
Lack of due process alleged
Hi-Tech’s case, which has gone of for several years, pits FDA’s mandate to protect public health against the concept of due process before the government takes action against an individual or firm. Hi-Tech has argued that FDA’s use of its power of administrative detention to get DMAA off the market without conducting studies to provide scientific proof on the ingredient’s dangers violates this concept. Hi-Tech CEO Jared Wheat says the military’s own assessment of the soldier’s death exonerates DMAA, though the ingredient remains illegal to sell at base commissaries.
Hi-Tech had never disputed the fact that it uses synthetic DMAA in its products. What was in dispute was whether that ingredient could be found in the geranium plant as had been claimed. In the decision the judge found that FDA had not conclusively debunked the various studies that Hi-Tech put forward claiming to make this connection.
Judge: DMAA is in geranium
In his decision Judge Willis B. Hunt, Jr. found that Hi-Tech had provided “fairly substantial evidence that trace amounts of DMAA have been found in a species of a geranium plant.” The court gave particular weight to a 2013 review in Analytical Chemical Insights in which the author concluded that DMAA could be found in some geranium plants but not in others and that the negative results of some studies could be attributed to inappropriate extraction methods.
But Hunt stopped short of endorsing Hi-Tech’s course of action, in which it has claimed that DMAA is an Old Dietary Ingredient because of this connection. While the decision supports the notion that chemical synthesis could help protect rare or endangered plant species that might otherwise be ravaged for the sake of a minor constituent, Hunt said the intention of Congress in passing DSHEA was clearly to connect botanical ingredients with a significant source in nature.
“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 statue,” he wrote
Door opened a crack on synthetics
However, Hunt ’s ruling appears to open the door for the legality of synthesized versions of botanical ingredients in cases where there has been a history of extraction from a source found in nature. FDAs stance at the moment via the updated NDI draft guidance is that synthesized versions of botanical constituents, in that they were never part of a plant, are not legal dietary ingredients. That is a blanket statement, and makes no reference to the concentration of those ingredients in the plant sources.
“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 plant-like organism,” Hunt wrote.
Hunt also concluded that while FDA has not made a conclusive case about the dangers of DMAA, there is no general agreement in the scientific community that the ingredient is in fact safe, so DMAA can’t be a GRAS ingredient.
Legal experts told NutraIngredients-USA that while the ruling might further embolden FDA in its attempts to scour the last bits of DMAA from the market, it drives a stake into the agency’s position on so-called synthetic botanicals.
“It was a very interesting decision, though I don’t want to overstate its precedential value which is only for the Norther District of Georgia. Nevertheless, it throws into question FDA’s position on synthetic botanical ingredients. Industry has questioned FDA’s position and this shows there may be a vulnerability in FDA’s attempt to keep these ingredients off the market,” said Marc Ullman, an attorney at counsel with the New York firm Rivkin Radler.
“From the DMAA standpoint this ruling is not a surprise,” said Justin Prochnow, a Denver-based shareholder in the firm Greenberg Traurig. “You can’t take a synthetic ingredient for which there is no history of extraction and make it a dietary ingredient. But if it’s a standard constituent [of a botanical] then that type of synthetically created extract could be a dietary ingredient. The trade organizations have not been looking to make things like DMAA into dietary ingredients,” he said.
Ullman noted that as Hunt’s ruling is a summary judgement, by the nature of that type of decision some points of law are passed over. And he said it’s unlikely this is the end of the FDA vs Hi-Tech story, as an appeal might be possible. As of publication time, Hi-Tech had not responded for a request for comment on whether it plans to appeal the decision.
perpetuating a lie
Posted by nathan beveridge,