New York Attorney General Eric Schneiderman and 13 other attorneys general sent a letter to Congress asking it to launch a comprehensive inquiry into the herbal supplement industry and give FDA more authority to regulate botanical supplements.
The letter is the latest development in a months-long investigation by Schneiderman that the industry fears could lead to states regulating dietary supplements and Congress enacting more federal regulations.
Specifically, the attorneys general asked Congress to work with FDA to review (my take in parentheses):
- Quality assurance (QA) measures for verifying the source, identity, purity, potency and quality of ingredients and fillers (However, this is already covered in the required supplement GMPs [good manufacturing practices]);
- Processes for verifying the identity, composition, purity, potency and quality of the finished products (Also outlined in GMPs);
- Product labels and marketing that may mislead consumers about the contents of herbal and dietary supplements and determine if FDA should develop standards and restrictions governing their use (numerous FDA warning letters show FDA’s current authority with regard to claims, and FTC also heavily regulates claims natural products make);
- The extent to which Congress should mandate, or direct FDA to develop, enhanced, uniform, industry-wide QA and verification procedures to guarantee the source, identity, purity and potency of materials incorporated into herbal and dietary supplements; (Also outlined in GMPs, and more development is happening here with the new Food Safety Modernization Act [FSMA], such as the newly required Food Supplier Verification Program [FSVP]) and,
- The extent to which Congress should mandate, or direct, FDA to develop enhanced manufacturing and supply chain management requirements for the industry to guarantee the safety and efficacy of the finished herbal and dietary supplements (Again, outlined in GMPs, and mandatory serious adverse event reports [AERs] must be submitted to FDA after such events are reported to supplement companies).
The letter comes on the heels of an investigation led by Schneiderman, which used DNA barcoding to test store-brand botanical products at GNC, Target, Walgreens and Walmart. Despite outcry that DNA testing is not fit for purpose for botanical extract products, the New York Attorney General has stood by the results, which reported the products didn’t contain much of the active ingredients noted on the label and were contaminated with allergens, off-label plant species and other substances.
However, as Loren Israelsen, president, United Natural Products Alliance (UNPA), noted, “We have yet to learn the details of what these ‘allergens, other plants or dangerous substances’ are. The New York AG continues to refuse to release this critical data, which does not allow a proper response from industry."
“It is unfortunate that the New York State Attorney General has spearheaded a request for Congress to spend taxpayers’ money to ‘launch a comprehensive congressional inquiry into the herbal supplements industry’ when the industry is already amply regulated on a federal level by FDA and FTC," said Steve Mister, president and CEO, Council for Responsible Nutrition (CRN). “In fact, concerns raised in that letter about alleged widespread safety issues are not true, based on government’s post-market surveillance system, which demonstrates relatively few safety issues for these products, particularly in comparison to other industries regulated by FDA."
Mister said that during the past month, CRN has met with a number of state attorneys general to explain how supplements are regulated and the limitations of DNA barcode testing for botanical extracts. “We are gratified that the concerns go away once we’re given the opportunity to fully explain the issue," Mister said. “Herbal supplements are regulated by FDA as a category of food, and substantial regulations are in place for pre-market notification of new ingredients, GMPs (including identity testing of both raw materials and finished products), product labeling and post-market surveillance (i.e., mandatory reporting of any serious adverse events associated with these products)."
Natural Products Association (NPA) CEO and executive director Daniel Fabricant, Ph.D., former director of the FDA’s Division of Dietary Supplement Programs, said this most recent action by Attorney General Schneiderman is “harassment based on science fiction. For the past two months, the attorney general has continued to escalate his attack on the supplement industry without any legitimate data to back up his arguments."
Fabricant said as the head of FDA’s Division of Dietary Supplement Programs, he has seen the agency take swift and forceful action when dietary supplement companies violate federal regulations. “The FDA is properly equipped to identify and go after firms that pose a threat to public health. Attorney General Schneiderman’s claims that the FDA doesn’t have ample authority in this area show a complete misunderstanding of the regulatory structure in place to protect consumers and remove products from the market."
Mister said the solution is not to give FDA more regulatory power, but to give it funds to enforce the laws that are currently on the books. “CRN is a strong and vocal advocate for more resources to FDA for stronger and swifter enforcement of these existing regulations. We acknowledge there are some problems facing our industry, and we wish that the state attorney generals had focused their efforts on helping solve the serious problem of criminals who spike products with illegal drugs and market them illegally as dietary supplements."
Fabricant added, “NPA encourages Attorney General Schneiderman to direct his time and resources toward issues that truly do present a danger to consumers, and end his efforts to take away products that contribute daily to the overall health and wellness of hundreds of millions of Americans."
However, the letter to the Congressional leaders said the attorneys general “will continue to vigorously pursue supplement manufacturers and retailers who break public health and consumer protections laws, and endanger the health and well-being of the residents of our states. Congress and the FDA, however, are ideally positioned to hasten a broad-based solution that guarantees the safety, efficacy, and reliability of the herbal supplements sold nationwide."
An FDA spokeswoman did not immediately respond late Thursday to a request for comment concerning the attorneys general letter.
Earlier this week, GNC reached a deal with Schneiderman, ending the Attorney General’s investigation of GNC’s products. GNC, which faces a barrage of lawsuits in connection with Schneiderman’s findings, said it will use DNA barcoding to authenticate raw materials that it will use to create its botanical products. In the agreement with GNC, the supplement company admitted no fault and Schneiderman acknowledged that GNC followed the GMP regulations set in place by FDA.
Mister noted the agreement between the New York Attorney General and GNC “explicitly stated that there were no issues with the herbal supplements being investigated, and because of this, the products were returned to the store shelves."
That no-fault provision was “the lynchpin of the agreement for GNC, and it demonstrates beyond any doubt the purity, safety and quality of the products," a source familiar with the settlement negotiations told Natural Products INSIDER. “DNA barcode testing may someday play a role in the testing of some source material. GNC agreed to devote resources to advance this technology," the source said in a phone interview.
The source added the testing will confirm the authenticity of active botanical ingredients prior to extraction. The DNA testing will not replace current testing but will be in addition to such tests, the person said.
Fabricant added, “Attorney General Schneiderman has admitted that the federal GMPs currently in place for dietary supplements are sufficient, and companies such as GNC are in compliance with those, but yet he moves forward in his request to spend federal taxpayer dollars on an investigation into an industry that is fully regulated by the FDA."
A high-level and veteran executive in the dietary supplement industry who agreed to speak on condition of anonymity due to the sensitivity of the issues predicted the expanding attorneys general probe will become the biggest battle in the supplement industry since the debate over the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Israelsen said UNPA anticipates the possibility of Congressional hearings in the fallout of this letter. These “would generate substantial negative media with the usual critics being provided a big megaphone and with little opportunity for response."
Israelsen concluded, “This news is troubling and indicates the storm is growing rather than abating fueled by test results discredited by virtually all informed parties and without the disclosure of facts that should precede any public discussion of the sort being requested."
Along with Schneiderman, the letter to Congressional leaders was co-signed by Attorneys General Greg Zoeller (R- Indiana), George Jepsen (D-Connecticut), Karl Racine (D-Washington DC), David M. Louie (D-Hawaii), Lawrence Wasden (R-Idaho), Tom Miller (D-Iowa), Jack Conway (D-Kentucky), Maura Healey (D-Massachusetts), Jim Hood (D-Mississippi), Joseph Foster (D-New Hampsire), Joey P. San Nicolas (D-Northern Mariana Islands), Kathleen Kane (D-Pennsylvania) and Peter Kilmartin (D-Rhode Island).
Additional reporting for this blog was contributed by Josh Long, INSIDER chief legal correspondent.