DNA testing has put criminals behind bars and exonerated the wrongly incarcerated, but can it tell you what’s in an herbal supplement?

Last week, New York’s Attorney General Eric Schneiderman with great fanfare sent cease-and-desist letters to four major retailers -- GNC, Target, Walmart and Walgreens --demanding that the companies stop selling six popular herbal supplements that he alleges don’t contain the ingredients listed on the label. And like night follows day, multiple class actions were filed by plaintiff’s lawyers in California.

But the supplement industry is fighting back -- bigtime.  In unusually sharp criticism of the top law enforcement officer of a major state, the Council for Responsible Nutrition calls the NYAG’s action a “self-serving publicity stunt,” and the American Herbal Products Association accuses the NYAG of using an “inadequate and unproven analytical method.” Both trade associations have called on the NYAG to release its entire test report.

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In his letters, the NYAG alleges that labels on certain store brand herbal supplements sold by these retailers, including Ginseng, Echinacia, St. John’s Wart, Saw Palmetto, and Gingko Biloba, are mislabeled because (1) they do not contain any of the herbs that they were labeled as containing; and (2) they contain plants that were not listed on the labels (such as rice, beans, pine, citrus, asparagus, primrose, wheat and carrot). 

The NYAG bases its claims on DNA barcode tests that it performed on the products at issue. DNA barcodes are short genetic markers in an organism’s DNA that, under some circumstances, can be used to determine an exact plant species. But, in part, because the manufacturing process of herbal supplements can often remove or damage DNA, critics argue it does not work for some herbal supplements, particularly extracts, where the plants’ DNA may be broken up and denatured.

The FDA does not require DNA testing but does require that companies adhere to Good Manufacturing Processes (GMPs), which include identity testing for all botanical materials used at different stages of the processing of those ingredients.  Supplement companies often use chromatography, microscopy, and organolepsis (sensory review) to identify plant ingredients.

The NYAG’s press release shows he holds the supplement industry in low regard, quoting an activist as saying “The evidence for these herbs’ effectiveness is sketchy to begin with” -- a point his study does not attempt to substantiate.  While there have been publicized instances of some less well-known companies misrepresenting ingredients, the industry claims these are outliers.  In fact, some in the industry have accused their competitors of such misbranding. 

The NYAG action highlights the increasing role that states play in product regulation. State AG’s have access to the media and a broad grant of jurisdiction, but they usually have less expertise and industry knowledge than federal regulatory agencies. As this battle plays out, it is unlikely to take DNA testing to determine whether the NYAG has egg on his face.