Call on Congress to give stronger oversight role to FDA
New York Attorney General Eric Schneiderman and Indiana Attorney General Greg Zoeller on Thursday said the bipartisan group of state attorneys general has sent a letter to Congress asking lawmakers to examine the possibility of the Food and Drug Administration taking a stronger role in oversight of herbal supplements.
In early February, the New York attorney general’s office sent cease-and-desist letters to Walgreens, Walmart, Target and GNC to stop selling certain store-brand herbal supplements because DNA barcode testing couldn’t verify that the products contained the labeled substance, or the supplements were found to contain ingredients not listed on the labels. Later that month, Schneiderman’s office expanded its probe by sending letters to four manufacturers of dietary supplements — Pharmavite LLC, Nature’s Way Products Inc., NBTY Inc. and Nutraceutical Corp. — to request information on the ingredients and quality control measures used for their products sold in New York.
Then in March, Schneiderman announced the formation of a coalition of state attorneys general from Connecticut, Indiana and Puerto Rico to further investigate herbal supplement industry business practices. And earlier this week, GNC Holdings Inc. said it reached an agreement with the New York attorney general that restores the full assortment of its Herbal Plus products to all stores in the state and expands the retailer’s testing processes deeper into its supply chain.
“When consumers take an herbal supplement, they should be able to do so with full knowledge of what is in that product and confidence that every precaution was taken to ensure its authenticity and purity,” Schneiderman said in a statement Thursday. “I am proud to stand with a bipartisan group of attorneys general calling for a Congressional inquiry into whether stronger FDA oversight of the herbal supplements industry is needed. My office’s investigation reaffirmed long-standing concerns about the herbal supplements industry. The millions of consumers who take herbal supplements deserve to know whether they are getting what they pay for and that these products are properly labeled and safe.”
Besides Schneiderman and Zoeller, the letter to Congress wassigned by state attorneys general George Jepsen of Connecticut, Karl Racine of the District of Columbia, David Louie of Hawaii, Lawrence Wasden of Idaho, Tom Miller of Iowa, Jack Conway of Kentucky, Maura Healey of Massachusetts, Jim Hood of Mississippi, Joseph Foster of New Hampshire, Edward Manibusan of the Northern Marianas Islands, Kathleen Kane of Pennsylvania and Peter Kilmartin of Rhode Island.
“My focus is on ensuring the best consumer protections for dietary and herbal supplements and eliminating potential false or deceptive labeling that could be harmful to consumers,” Zoeller stated. “My fellow attorneys general and I are urging Congress to consider stronger federal oversight of the herbal supplements industry so that members of the public have full information about a product they are ingesting.”
Supplement industry stakeholders have blasted the New York investigation, in particular its reliance on DNA barcode testing, which they called an unreliable and limited method for testing the identity of herbal dietary supplements. Schneiderman also has been criticized for not releasing the detailed findings of the state investigation.
“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. 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,” Steve Mister, president and chief executive officer of the Council for Responsible Nutrition (CRN), said in a statement released Thursday.
“The basis of the report — a testing methodology known as DNA barcoding — is simply an inappropriate methodology for testing herbal supplements made from herbal extracts, thereby making the NY AG’s report misleading,” he noted.
Herbal supplements are regulated by the FDA as a category of food, and substantial regulations are in place for pre-market notification of new ingredients, good manufacturing practices (including identity testing of raw materials and finished products), product labeling and post-market surveillance (such as mandatory reporting of any serious adverse events related to these products), Mister added.