New York Attorney General Eric Schneiderman took aim at the nutritional supplement industry on Feb. 2 by sending cease-and-desist letters to the retailers GNC, Walgreens, Target and Walmart. He claimed testing of dietary supplements purchased from these retailers revealed the products either didn’t contain the botanical material listed on the label or contained extensive amounts of non-listed ingredients, such as rice, asparagus and common houseplants. At least one of the retailers promptly removed the supplements from its shelves in response, and a spate of class action litigation seemed sure to follow. The testing methodology used by Schneiderman’s office, however, subsequently came into question, and may blunt the effect of the Attorney General’s actions.
Nutritional supplementswhich include vitamins, minerals, herbs and other botanicalsmake up a multi-billion dollar industry in the United States. Unlike prescription drugs, supplements are not subject to FDA’s approval process. Over the years, supplements have been widely criticized as being ineffective or, in some cases, harmful. Yet sales of these products continue to rise at an impressive clip.
In launching his attack on the nutritional supplement industry, Schneiderman’s office chose not to attack either the efficacy or the safety of the supplements. This would have required a complex, costly and time-consuming scientific study. Instead, the Attorney General took aim at the labeling of the products, using an emerging technology to determine, according to Schneiderman’s press release, that the supplements tested “either could not be verified to contain the labeled substance, or which were found to contain ingredients not listed on the labels." The press release claimed the tested products contained such “contaminants and fillers" as “rice, beans, pine, citrus, asparagus, primrose, wheat, houseplant, wild carrot and others." According to the press release, the testing carried out on behalf of the Attorney General’s office substantiated “what appears to be the practice of substituting contaminants and fillers in the place of authentic product."
To reach its conclusions, the Attorney General relied on a process known as DNA barcoding, which uses small segments of mitochondrial DNA to identify an organism. DNA barcoding has the advantage of being both fast and inexpensive; some laboratories can obtain the required genomic sequences in a matter of hours for less than $10. These sequences are then compared against a database to identify the species of the specimen being tested.
Schneiderman’s approach raised the specter of similar actions by other attorneys general, as well as a flood of class action litigation. After all, a plaintiff’s lawyer must invest relatively little in laboratory testing to claim that consumers were duped into buying mislabeled products. With sales in the tens of billions of dollars, the nutritional supplement industry would seem to be an inviting target.
There are serious questions, however, concerning the efficacy and appropriateness of DNA barcode testing for nutritional supplements. Most nutritional supplements do not contain “whole plant" products; rather, they contain plant extracts that are prepared using some type of solvent. These solvents, along with the extracting process itself, can destroy DNA. Therefore, a DNA barcode test of processed extract of Ginkgo biloba may not identify any Ginkgo biloba. In addition, it is unclear whether the testing carried out for Schneiderman’s office determined the amounts of rice, asparagus and other non-listed ingredients in the supplements tested. Such inert ingredients, provided that they exist in only trace amounts, do not have to be listed on a product label unless they are allergens. If the DNA barcode testing carried out for the Attorney General did not differentiate among ingredients by the amounts contained in a supplement, the presence of carrots and houseplants may make for effective publicity, but is otherwise meaningless.(If, on the other hand, those ingredients were present in more substantial qualities, the supplements could be considered mislabeled.)
The Attorney General’s testing also did not follow the standard testing methods of the United States Pharmacopeial Convention (USP), a nonprofit scientific organization that sets standards for the identity and purity of medicines, food ingredients and dietary supplements. USP’s validated identification methods include, for example, microscopic examination of botanic characteristics and chemical tests such as chromatography to determine the presence of various ingredients, even if the DNA has been destroyed.
Despite the questions concerning the testing methods upon which Schneiderman relied, litigation is likely to follow. Particularly because nutritional supplements are not always viewed favorably by the public (and, therefore, potential jurors), because rice and asparagus strike many as misplaced in a nutritional supplement, and because DNA barcode testing is so inexpensive and fast, some plaintiffs’ lawyers will find the allure of a misbranding claim impossible to resist.
To limit the likelihood of a lawsuit, and to prepare for the possibility of legal claims, manufacturers and distributors should verify their products are manufactured using cGMPs (current good manufacturing practices). Second, manufactures and distributors should ensure their products contain the ingredients listed on the label by having the products independently tested using USP protocols. Third, the focus of any litigation will likely involve USP test results and DNA barcoding results. Consequently, manufacturers and distributors should be familiar with the testing methods used by their own outside laboratories, understand the weaknesses of DNA bar code testing and, preferably, conduct both DNA barcode testing and testing using USP methodologies on identical product samples to highlight differences in the test results. Finally, manufacturers should ensure that all test data, cGMP documentation and supply chain information is on hand and readily available. Advance preparation will help immeasurably in responding to media and attorney general inquiries, as well as in defending or precluding lawsuits.
Read more on the NY AG’s dietary supplement probe by visiting INSIDER’s Supplement Law blog.
Creighton Magid is a partner, head of the Dorsey and Whitney Washington office, a member of the electronic discovery practice group, and co-chair of the firm-wide products liability practice. He practices in the areas of fiduciary, technology, commercial and products liability litigation.