Attorneys general of 14 states are calling on Congress to take a closer look at the herbal supplements industry, including whether stronger federal oversight is needed, the attorneys general of Indiana and New York announced Thursday.
Industry representatives immediately criticized the request, saying the concerns are unfounded.
“It is unfortunate that the New York State Attorney General has spearheaded a request for Congress to spend taxpayers' money … when the industry is already amply regulated on a federal level by FDA and FTC,” according to a statement by Steve Mister, president and CEO of industry group the Council for Responsible Nutrition.
“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,” the statement continued.
But New York Attorney General Eric Scheiderman's office said the request follows a New York investigation that raised concerns about the marketing and safety of herbal supplements.
“The multibillion dollar herbal supplements industry is built on the promise that its products will improve the health and well-being of those who use them,” according to a letter the 14 AGs sent Thursday to leaders of two congressional committees. “Yet, a current state investigation has raised serious concerns about the marketing and safety of the herbal supplements regularly consumed by millions of Americans.”
The AGs urged Congress in the letter to launch a “comprehensive congressional inquiry” into the industry and “to weigh a more robust oversight role for the Food and Drug Administration.”
Specifically, they asked Congress to explore a number of questions, including the adequacy and effectiveness of existing quality assurance measures for verifying the source, identity, purity, potency and quality of supplements' ingredients.
They also want Congress to look into the adequacy and effectiveness of processes for verifying the identity, composition, purity, potency and quality of the supplements as finished products; the degree to which product labels might be misleading and whether the FDA should develop standards; and the extent to which Congress should direct the FDA to develop uniform, industrywide processes for quality assurance and verification.
They also want Congress to examine the extent to which it should direct the FDA to develop enhanced manufacturing and supply-chain management requirements.
The attorneys general of Indiana, Connecticut, Washington, Hawaii, Idaho, Iowa, Kentucky, Massachusetts, Mississippi, New Hampshire, Pennsylvania, Rhode Island and the Northern Mariana Islands also signed the letter.
The letter follows a recent analysis commissioned by the New York attorney general's office that found contaminants, unlabeled plant species and other substances in some store-brand supplements. It also found that, in some supplements, the genetic material of the original plant source was either undetectable or not present at all.
Following that investigation, Schneiderman's office in February sent cease-and-desist notices to GNC, Target Corp., the Walgreens' holding company Walgreens Boots Alliance and Wal-Mart Stores, regarding sales of their store-brand supplements.
An agreement was announced Monday between Schneiderman and GNC Holdings that will require the company to implement new testing standards for its herbal supplements that go beyond federal requirements. The retailer will perform testing on all “active” plant ingredients listed on supplement labels and test for contamination with allergens before and after production.
Industry groups, however, have widely criticized the tests the AG performed as part of its initial analysis as flawed. The Council for Responsible Nutrition said 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.”
Industry groups also point out that they are already subject to FDA scrutiny.
The FDA requires herbal supplement companies to verify that their products are safe and properly labeled, but supplements do not face the same type of FDA oversight as prescription drugs.
The FDA may take action against adulterated or misbranded supplements after they reach the market, under the Dietary Supplement Health and Education Act, a 1994 law sponsored by Sen. Orrin Hatch (R- Utah), a lawmaker known for his support of the nutritional supplement industry.
