New York’s Attorney General initiated the investigation against major retailers of herbal supplements, based on DNA testing of plant materials suggesting contaminants, and mislabeling; was the investigation premature? The AG’s cease and desist letter went out to 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 letters, sent Monday, call for the retailers to immediately stop the sale of certain popular products, including Echinacea, Ginseng, St. John’s Wort, and others. Attorney General Schneiderman requested the companies provide detailed information relating to the production, processing and testing of herbal supplements sold at their stores, as well as set forth a thorough explanation of quality control measures in place.
The letters come as DNA testing, performed as part of an ongoing investigation by the Attorney General’s Office, allegedly shows that, overall, just 21% of the test results from store brand herbal supplements verified DNA from the plants listed on the products’ labels — with 79% coming up empty for DNA related to the labeled content or verifying contamination with other plant material.
The AG asserted: “Mislabeling, contamination, and false advertising are illegal.”
The press release noted that FDA requires dietary supplement companies to “verify that their products are safe and properly labeled for their contents, but unlike drugs, supplements do not undergo the agency’s rigorous evaluation process, which scrutinizes everything about the drug—from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured.”
Curiously, the investigation came from the New York AG and not from FDA itself. And, attorneys general from additional states have announced they wish to join the investigation.
But industry experts are questioning the DNA barcoding upon which the investigation relies. A Forbes article states: “This testing method, which provides a genetic fingerprint and has been used to root out fraud in fish and milk scandals, is not definitive for testing herbal extracts because DNA material is necessarily eliminated or denatured during the extraction and purification process.”
Regardless of the outcome of the controversy over the testing method, the reality is that dietary supplement companies now face regulatory hurdles additional to the “usual suspects.” New York’s AG has demanded that the target companies produce information including:
- The name, concentration, country of origin, and any extraction method used for each component of the supplement;
- A description of analytic testing used to confirm the content and quality of any ingredient as well as the finished product;
- A detailed description of measures taken to ensure quality across the supply chain from farm to factory;
- Testing done to substantiate label claims such as “gluten free” or “hypoallergenic;”
- Copies of all documents related to adverse health consequences, including allergic reactions.
Herbal supplement sales are estimated at $6 billion a year. The latest state-level enforcement action adds to dietary supplement companies’ legal and regulatory burdens – appropriately so, from the perspective of the regulators. However, many dietary supplement companies, like medical device and cosmetics / cosmeceutical companies, tend to underestimate their legal and enforcement hazards.
Some of the legal and regulatory risks that dietary supplement companies must mitigate include the risk of:
- FDA enforcement action for misbranding
- FDA enforcement action for adulteration
- FTC action for false and deceptive advertising
- Private plaintiff consumer remedies litigation based on FDA, FTC, and state food and drug law violations
- AG action for healthcare fraud, and/or investigation for mislabeling such as in the current New York investigation
Whenever dietary supplement companies seek legal and regulatory advice, our FDA attorneys remind them that there are several components of legal review, each of which is critical:
- Reviewing and analyzing the claims (i.e., to be sure the company is making proper structure/function claims and not therapeutic, drug, or disease claims)
- Reviewing or drafting the product label (which must comply with relevant FDA guidance and regulations)
- Reviewing or advising on substantiation (to ensure the claims are back by competent and reliable scientific evidence)
- If private labeling is involved, reviewing or drafting a private labeling manufacturing agreement.
Attorneys cannot ensure that the product contains the ingredients the label says it contains; that is up to the company. But, the company has an obligation to avoid misbranding and adulterating the product, and must abide by the specifications in FDA’s labeling rules.
Many companies forget to substantiate their dietary supplements. This is all right as long as FTC doesn’t notice; however, a plaintiff’s law firm may be delighted to find these gaps in compliance, and the nascent dietary supplement company could find its product crushed by litigation before much market penetration. The best move is to contact an experienced FDA and FTC lawyer for legal advice before bringing consumer products to market in the health and wellness industry.