On Feb. 3, 2015, New York State Attorney General Eric Schneiderman unleashed a maelstrom of (incredibly) bad publicity for the entire dietary supplement industry with the publication of a press release announcing that GNC, Target, Walmart and Walgreens had been selling herbal supplements without the herbs. Following the Attorney General’s press release, newspaper editorial pages including The New York Times (“Herbal Supplements Without Herbs"), The Washington Post (“A Recipe for Trouble") and Long Island Newsday (“Uncle Sam Should Stand Guard Against Fake and Dangerous Supplements") immediately condemned both an “irresponsible" industry and an alleged lack of adequate federal regulation for creating a situation where consumers are regularly defrauded and perhaps even injured by products that are supposed to be promoting good health. While industry has pushed back against the Attorney General’s claims of rampant adulteration, Schneiderman pressed ahead with his onslaught against the supplement trade.
The Attorney General’s Tests
In his Feb. 3 press release, Attorney General Schneiderman boldly announced his office “sent letters to four major retailers, GNC, Target, Walmart and Walgreens, for allegedly selling store brand herbal supplement products in New York that either could not be verified to contain the labeled substance, or which were found to contain ingredients not listed on the labels." The release also stated DNA testing revealed 79 percent of the products tested failed to contain any amount of the declared herbal ingredients, verifying that the same products were contaminated with a variety of undeclared material.
One day after the Attorney General made his “investigation" public, U.S. Sens. Richard Durbin (D-IL) and Richard Blumenthal (D-CT) issued a joint press release calling for FDA to launch a nationwide investigation into the four companies cited by the Attorney General. Relying on the DNA test results cited by the Attorney General, Sen. Blumenthal announced, "The apparent widespread sale of fraudulently labeled dietary supplements by four major national retailers should be a major wake-up call that the industry is in desperate need of additional oversight."
In response to this barrage of media and official criticism, the industry quickly pointed out that the Attorney General apparently used the wrong test to check on the quality of the supplements. Expert organizations including the US Pharmacopeia suggested the DNA tests were inappropriate for herbal extracts—the exact products tested by the Attorney General—because the extraction process could leave behind active constituents, but no DNA. Herbalist Stephen Foster pointed out that there’s likely no DNA to be found in the most popular herbal extract of all—a cup of coffee. Trade associations including the Natural Products Association (NPA), the Council for Responsible Nutrition (CRN) and the American Herbal Products Association (AHPA) also attacked the Attorney General for picking the wrong test method and for refusing to release details concerning the precise methods used and the results reported.
Rather than respond with disclosure of his test methods and results, the Attorney General shifted his “investigation" to question whether the four retailers he targeted could substantiate the structure/function claims made for the products allegedly containing none of the ingredients listed on their labels. The Attorney General’s new focus was revealed in a Feb. 12 blog post on The New York Times website (“Chains Pull Dietary Aids Off Shelves After Inquiry"), attributing the disclosure of the shift in the investigation to “a law enforcement official with knowledge of the investigation, who was not authorized to discuss the case." The unnamed source stated that subpoenas issued to the retailers “demanded that the four retailers provide evidence of how they would prove the authenticity of their product claims."
The problem for the Attorney General with this shift in focus was that the subpoenas sought information on some of the most studied herbal ingredients in the market, including St. John’s wort, Ginkgo Biloba, ginseng and Echinacea. While this move garnered the Attorney General a fresh round of publicity, suggesting that he was protecting consumers from products “not currently subjected to the FDA’s testing standards," serious questions remained as to the reasons for the sudden shift in his focus. Meanwhile, the Attorney General continued his refusal to release any substantive information connected to the DNA test results, even though at least one of the accused companies forcefully responded that its products were manufactured with exactly the ingredients claimed on its labels.
On Feb. 23, Attorney General Schneiderman further expanded his investigation, issuing subpoenas to Nature’s Way, NBTY, Nutraceutical Corp. and Pharmavite, seeking virtually all manufacturing records for a number of products produced by these companies and sold in New York. According to the Attorney Genearl’s’s spokesman, the action was taken to ensure consumers were “protected against deceptive claims on packaging and against potentially dangerous reactions to undisclosed ingredients." All of the documents sought in the Attorney General’s latest salvo are required by federal regulations and are regularly reviewed by FDA during routine inspections to verify compliance with GMPs (good manufacturing practices) for dietary supplements.
Other than to generate another round of publicity for himself, the Attorney General’s rational for seeking routine manufacturing records remains unclear. A profile of AG Schneiderman published in the New York Observer painted a picture of an ambitious politician, ready to take on questionable cases and trample anyone in his way if he believes that it will advance his career. With this in mind, it is quite possible that the issuance of subpoenas, which will yield thousands of pages of master manufacturing records (MMRs) and batch production records (BPRs), was triggered by a simple desire for good PR, regardless of the damage that might be inflicted on the companies or industry targeted, in this case, the dietary supplement industry.
Responding to the Attorney General
Despite a concerted campaign pressing the Attorney General to release the data behind his initial attack on the supplement industry, it appears the matter will drag on for some time with no relief. Efforts to rationally address the questions surrounding problems with the initial testing conducted in New York have gone unanswered. A careful reading of the New York Observer profile, however, indicated this should not have been unexpected. Instead, the industry should be prepared to respond by asking tough questions about his judgment, including whether he is making wise choices spending taxpayer money on fishing expeditions designed to distract from his first misguided examination of the supplement industry.
New York residents (like me) need to remind the Attorney General that we expect answers, that we vote, and that we will hold him accountable the next time his name is on the ballot. Unless stakeholders become sufficiently involved to the point Attorney General Schneiderman understands that stakeholders in the industry have the will and the ability to inflict damage on his political ambitions, his targeting of dietary supplements is not likely to end anytime soon.
Marc Ullman is a partner at the New York-based law firm Ullman, Shapiro & Ullman LLP.