AHPA: FDA Wrong About Synthetic Botanicals

SILVER SPRING, M.D.In response to FDA sending 10 warning letters to DMAA marketers, the American Herbal Products Association (AHPA) said the agency is wrong in its belief that human-synthesized constituents of botanicals are not dietary ingredients.

"The agency's position on this ignores the fact that synthesized vitamins, minerals, amino acids and botanical constituents were already marketed at the time DSHEA was passed," said Michael McGuffin, president, AHPA. "In AHPA's view, if DMAA exists in geranium through the plant's own synthesis processes, human-synthesized DMAA is also a lawful dietary ingredient."

McGuffin noted the letters show FDA has restated its view that a synthetic constituent of botanical cannot is not a constituent of a botanical," one of the categories that makes a compound a legal dietary supplement as outlined in the Dietary Supplement Health and Education Act of 1994 (DSHEA). "But if the language of the warning letters is read carefully, it appears that the agency does leave room for a synthetic constituent of a botanical to be included as a 'dietary substance for use by man,' so long as that synthetic constituent is 'commonly used as a food or drink' (examples might be synthetic caffeine, or synthetic lycopene)."

In the April 24 warning letters, FDA also stated no information demonstrates DMAA is found naturally in the food supply. AHPA noted last September, Cantox Health Sciences International asserted two analytical laboratories have demonstrated the occurrence of DMAA in the geranium plant (Pelargonium graveolens), which would corroborate data originally published in 1996.   "AHPA looks forward to publication of this new analytical work," McGuffin said.

 The FDA warning letters also stated without citation that the ingredient "narrows the blood vessels and arteries, which increases cardiovascular resistance and frequently leads to elevated blood pressure. This rise in blood pressure may increase the work of the heart such that it could precipitate a cardiovascular event, which could range from shortness of breath to tightening of the chest and/or a possible myocardial infarction (heart attack)." However, AHPA said recently published studies on the effect of DMAA on healthy volunteers reported that the ingredient was generally well tolerated by participants.

FDA issued the warning letters on April 24 stating that DMAA products are adulterated due to allegations that the companies did not submit new dietary ingredient (NDI) notifications. Further, the agency said the products have not demonstrated that they are safe enough to market in the United States.

 "FDA has now signaled that it will act against companies that have not filed an NDI notification for an ingredient that the agency believes is an NDI," McGuffin said. "DSHEA has always included the NDI provision and its notification requirement. FDA has now demonstrated that it is willing to enforce the NDI provisions of the law, as it interprets them. We may not agree with the interpretation, but FDA is clearly willing to bring enforcement actions."

 While McGuffin said he couldn't speculate how FDA's future actions will affect specific ingredients, he said  the issuance of these letters may affect companies that sell innovative supplement products. "They may start to review their product lines to see if the ingredients have any similarities to DMAA. And they may also consider whether to file an NDI notification, based on a better understanding that the law created only a notification process, and not an FDA premarket approval authority."

Find out more about what supplements companies may expect from the U.S. government in the "Washington Update" education session at SupplySide MarketPlace on Wednesday, May 9, from 2 p.m. to 4 p.m., Javits Center, New York.