FDA Responds to New York, Indiana AGs on Dietary Supplement Regulations

FDA last week responded to concerns raised by the Indiana and New York attorneys general over regulations governing the dietary supplement industry.

The attorneys general in June urged the food-safety agency to reform oversight of the supplement industry, step up enforcement and act swiftly on a citizen petition that requested FDA subject ingredient suppliers to manufacturing regulations that were adopted eight years ago.

“In your letter, you share your concerns about the Dietary Supplement cGMP regulation and FDA’s enforcement," FDA Deputy Commissioner of Policy, Planning, Legislation & Analysis, Jeremy Sharp, wrote in an Aug. 7 letter to Indiana Attorney General Greg Zoeller. “With respect to enforcement, please be assured that we have pursued inspections and actions based on the Dietary Supplement cGMPs and will continue to do so taking into account our resources and priorities based on risk."

FDA also sent a letter to New York Attorney General Eric Schneiderman. Schneiderman’s office, which launched a probe earlier this year into four national retailers that sell botanical supplements, declined to comment on the letter.

Molly Gillaspie, a spokeswoman for the Indiana Attorney General’s office, said the agency is reviewing the letter “to determine what further action may be required to protect the health and safety of consumers who are ingesting these products."

“The Indiana Attorney General, as the state’s top consumer protection advocate, remains concerned that current federal regulations do not go far enough to protect consumers from deceptive labeling and ensure quality control in the industry," Gillaspie said Tuesday in an emailed statement.

As Natural Products INSIDER reported in July, FDA has successfully shut down at least 11 dietary supplement companies that haven’t followed cGMPs (current good manufacturing practices) since the fall of 2010. And earlier this month, the U.S. Justice Department announced that three Wisconsin-based supplement firms had agreed to cease operations under a consent decree of permanent injunction that was awaiting court approval.

The dietary supplement industry has come under increasing fire after Schneiderman divulged in February that DNA testing concluded a number of herbal supplements sold in New York failed to contain the labeled herbs and were tainted with substances that were not listed on the products’ labels.

Although botanical experts have questioned the reliability of DNA barcoding in testing the finished products, federal lawmakers, attorneys general and other critics have increasingly questioned whether the supplement sector is subject to appropriate oversight and enforcement.

"It is important to remember that the attorneys general's concerns and allegations are based on a misunderstanding of the results of DNA barcode testing that was not validated or fit for the purpose for which it was applied," said Michael McGuffin, president of the American Herbal Products Association (AHPA), in an emailed statement. "FDA's letter effectively explains how comprehensive federal regulations help ensure the quality and safety of herbal dietary supplements and should help correct the misinformation sparked by the faulty testing of certain herbal supplement products."

In May, the Organic & Natural Health Association requested that FDA subject ingredient suppliers to cGMPs governing the supplement industry. Schneiderman and Zoeller later urged FDA to act swiftly on the petition.

“Excluding suppliers from existing regulations is all the more concerning given that manufacturers typically receive ingredients as unrecognizable vats of powder, analytical testing at this stage cannot adequately detect frauds, and the ingredient suppliers are often overseas and beyond the reach of effective enforcement actions," Schneiderman and Zoeller wrote in a May 26 letter to FDA Acting Commissioner Stephen Ostroff, M.D.

The burden falls on supplement manufacturers to ensure the ingredients in their finished products meet certain standards, Sharp advised Zoeller. He didn’t indicate whether FDA planned to act on the citizen petition. Eight years ago, FDA weighed the pros and cons of subjecting dietary ingredient suppliers to cGMPs, but the agency concluded the final regulations include “adequate controls" governing “the use of dietary ingredients used by the manufacturer of a dietary supplement." Supplement executives also have said ingredient suppliers will face a number of new obligations under the 2011 Food Safety Modernization Act (FSMA).

“The [cGMP] regulation requires a manufacturer of a dietary supplement to conduct at least one appropriate test or examination to verify the identity of each incoming ingredient before being used in a finished dietary supplement," Sharp advised Zoeller in the letter. “Manufacturers must also conduct appropriate tests or examinations to ensure the identity of other components, and determine if other specifications for the dietary ingredient and other components are met, or alternatively, rely on a certificate of analysis from the supplier of the ingredient with detailed documentation regarding the qualification and periodic re-qualification of the supplier."

Sharp further noted that FDA has authority to handle inaccurate claims on product labels. He also addressed concerns raised by the attorneys general that the cGMPs don’t require testing to ensure products are free of common allergens. Under the Food Allergen Labeling and Consumer Protection Act, Sharp explained, regulated foods including “dietary supplements are misbranded unless they declare the presence of each major food allergen on the product label using the common or usual name of that major food allergen."

Daniel Fabricant, Ph.D., executive director and CEO of the Natural Products Association (NPA), wasn't surprised by the agency's response.

“I think the tone is fine and helps to clarify issues around allergen labeling, etc.," he said in a phone interview.

Fabricant said NPA is continuing to meet with attorneys general to discuss various topics, including what the industry is doing to bolster consumer confidence.

“Everybody from the FDA to the attorney general’s office to the industry wants consumers to have confidence in the products they are taking," added Fabricant, who previously led FDA's Division of Dietary Supplement Programs. “We are going to keep working in that vein to ensure that."