Attorney General Eric T. Schneiderman and Indiana Attorney General Greg Zoeller sent a letter to Dr. Stephen Ostroff, acting commissioner of the Food and Drug Administration (FDA), urging the agency to immediately enhance its oversight of the dietary supplement industry by reforming its Dietary Supplement Current Good Manufacturing Practices (CGMP) regulations. The letter also calls on the FDA to revisit and strengthen its enforcement more broadly.
“There’s no need to wait for Congressional action to drastically improve federal oversight of the dietary supplement industry,” said Attorney General Schneiderman. “The FDA has the authority to rewrite the rules that govern the multibillion-dollar dietary supplement industry today. The health and safety of the tens of millions of Americans who take supplements every single day will continue to be jeopardized until these lax regulations are improved. I urge the FDA to use every tool at its disposal to protect consumers in New York and across the country from the unnecessary risk of tainted supplements.”
“The FDA can and should take action now to ensure common-sense protections are in place to protect people from ingesting products with potentially unknown or unsafe ingredients,” said Indiana Attorney General Zoeller. “As herbal and dietary supplements rise in popularity, our aim is to eliminate any misleading and deceptive labeling in this global industry before more people are harmed.”
The letter outlines four major flaws in the FDA’s CGMPs:
- Ingredient Suppliers: The CGMPs do not cover ingredient suppliers, which are often located overseas and beyond the reach of effective enforcement actions. Since manufacturers typically receive ingredients from suppliers as unrecognizable vats of powder, analytic testing at this stage cannot adequately detect frauds.
- Testing of Label Claims: The CGMPS allow manufacturers to set their own label specifications and then choose their own tests for confirming label claims. The tests used by most manufacturers often cannot distinguish genuine products from chemically similar natural and synthetic compounds. Manufacturers largely judge for themselves whether to test for known substitutes and contaminants. The FDA acknowledges that a combination of testing methods is preferable, but the CGMPs expressly mandate the use of only one test—leaving the use of additional tests to the discretion of manufacturers.
- Testing for Allergens: The CGMPs do not require manufacturers to engage in any confirmatory testing to ensure that supplements are free of common allergens, even where products are marketed as containing no allergens (e.g. “Gluten-Free”).
- Labeling Ambiguity: The CGMPs fail to define key terms commonly used by manufacturers on labeling of dietary supplements. These terms are poorly understood and manufacturers use them in ambiguous and conflicting ways. For example, with herbal supplements, the industry applies the term “extract” to a spectrum of products—from minimally processed plants to highly purified chemicals. When consumers buy a “natural” product—which typically features a root, a leaf, a flower, or a piece of bark on the label—they do not reasonably expect to receive a heavily processed chemical. Yet, more often than not, this is what they get.
You can view the full letter here.
This letter follows Attorney General Schneiderman’s historic agreement in March 2015 with GNC, one of the nation’s largest supplement retailers, to reform its manufacturing process for herbal supplements. Under the agreement, GNC will go beyond the FDA’s CGMPs by using DNA barcoding to authenticate plants used in supplements and adopt new testing standards to prevent contamination.
A month earlier, Attorney General Schneiderman sent cease-and-desist letters to GNC, Target, Walgreens, and Walmart after a scientific study commissioned by his office failed to detect identifiable genetic material for the plants depicted on the labels in most of the herbal supplements sold by the four major retailers. The study further detected DNA associated with plants not listed on the labels, as well as the presence of potential allergens.
Contamination in herbal supplements could pose a significant danger to those who have food allergies or take medication – and there have been a number of examples of supplements endangering consumer safety. A 2013 outbreak of hepatitis that struck at least 72 people in 16 states was traced to a tainted supplement. Last October, an infant at a Connecticut hospital died when doctors gave the child a popular probiotic supplement that was later found to be contaminated with yeast. A recent study by Columbia University found that more than half of probiotic supplements contain gluten—despite claims on their labels to the contrary.
Attorney General Schneiderman’s inquiry has benefited greatly from technical guidance from the FDA. Throughout this investigation, the Office of the Attorney General of New York has conferred with a range of experts, including from the FDA, the supplement industry, consumer advocates, and the scientific and medical communities. The section of the letter sent today that calls for the regulation of supplement ingredient suppliers is based, in part, on a citizen petition that was submitted to the FDA by the Organic & Natural Health Association on May 14, 2015.