New York, Indiana Attorneys General to FDA: Overhaul Supplement Regulations

Citing “grave public concern," attorneys general in New York and Indiana recently urged FDA to reform federal oversight of the dietary supplement industry and step up enforcement.

In a May 26 letter to FDA Acting Commissioner Stephen Ostroff that was made public today, New York and Indiana law-enforcement officials called for improvements in cGMPs (current good manufacturing practices) that govern the U.S. supplement industry.

The cGMPs neither cover ingredients suppliers nor require that supplement companies verify through testing that products are free of common allergens, according to the letter. New York Attorney General Eric Schneiderman and Indiana Attorney General Greg Zoeller also raised concerns that supplement manufacturers are granted discretion in using their own tests to confirm claims on labels, according to the letter. Finally, the state law-enforcement officials argued some terms on supplement labels such as “extract" and “natural" are ambiguous.

“There’s no need to wait for Congressional action to drastically improve federal oversight of the dietary supplement industry," Schneiderman said in a statement. “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."

Asked for a comment on the letter Tuesday, FDA spokeswoman Marianna Naum said the agency “will respond directly to the attorney generals." Ostroff, M.D., has been acting commissioner since March, and he oversees an agency that has been rotating supplement directors for more than a year.

The supplement industry has come under increasing scrutiny since Schneiderman revealed in early February that DNA tests found a number of herbal supplements failed to contain the listed herbs and were tainted with fillers and contaminants. While herbal experts lambasted his testing methodology as unreliable, New York’s top law-enforcement official has not relented in his criticism of the industry. He has expanded his probe, other state attorneys general have joined him, and a bombardment of negative media publicity has increasingly questioned whether supplements are adequately governed to ensure their safety and authenticity.

“It’s disappointing that the Attorney General from New York is spending his time acting as if there is a public health problem in the dietary supplement world instead of being honest with consumers about what he really found in his tests and about being transparent in the industry by [releasing the tests]," said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), in a phone interview.

Letters that Schneiderman’s office sent to national retailers whose products were tested revealed the “results were all over the map, and yet, he chose to take enforcement action using unreliable data," Mister added.

Daniel Fabricant, Ph.D., executive director and CEO of the Natural Products Association (NPA), said his association looked forward to educating Schneiderman’s office further on the various obligations governing the supplement industry under the Federal Food, Drug & Cosmetic Act.

“We still have educating to do," he said in a phone interview. “We look forward to the dialogue … and getting some things straight."

While the relationship between the supplement industry and Schneiderman’s office has been rocky at times due to his allegations of mislabeling and expanding investigation, efforts are underway to work together.

Last month, Fabricant and Schneiderman issued a joint statement in which the men looked “forward to jointly working with major manufacturers and retailers of herbal supplements to promote a model for product safety, authenticity, and transparency in this industry."

GMPs and Ingredient Suppliers

In the letter to FDA, Schneiderman and Zoeller cited a number of problems in the supplement industry. “The quality control and safety issues facing the dietary supplements industry are a matter of grave public concern," the attorneys general wrote. “Scientists and consumer advocates have repeatedly discovered dangerous natural and synthetic compounds, including powerful stimulants, anabolic steroids and prescription drugs, in commercially available dietary supplements."

The eight-year-old cGMPs, found in 21 C.F.R. Part 111, are intended to protect the public health and ensure the labeled ingredients match what’s actually contained in the bottles.

A number of supplement manufacturers, including smaller and medium-sized companies, have struggled to meet the regulations. As Natural Products INSIDER reported in March, of the 483 inspections in fiscal year 2014 (FY14), 62 percent or 298 resulted in the issuance of an FDA document that alleged noncompliance with cGMPs. Nearly one in five facilities that received a Form 483, or 58 inspections, purportedly failed to verify the identity of a dietary ingredient prior to use through a test or examination, reflecting the most common infraction cited by FDA inspectors, the data showed.

The attorneys general in Indiana and New York urged FDA to act swiftly on a recent petition that requested the agency subject ingredient suppliers to the cGMPs.

“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 to Ostroff.

In 2007, FDA decided to refrain from subjecting ingredient suppliers to the cGMPs. The agency concluded the final regulations include “adequate controls" governing “the use of dietary ingredients used by the manufacturer of a dietary supplement."

Since the regulations were adopted, Mister said manufacturers of finished products have informally imposed many requirements on their vendors, which has caused ingredient suppliers “to step up their game." More importantly, Mister said, regulations that are being adopted under the four-year-old Food Safety Modernization Act (FSMA) are creating additional requirements on all food ingredient suppliers, including supplement vendors.

“This call to FDA to rewrite 111 totally ignores what has happened with FSMA," he said.

Michael McGuffin, president of the American Herbal Products Association (AHPA), expressed support to bolster enforcement of FDA supplement regulations.

"But AHPA does not believe there would be any increased product quality or benefit to consumers to require ingredient companies to comply with the dietary supplement cGMP rule at this late date," McGuffin said in an emailed statement.

McGuffin explained that cGMP and preventive controls regulations will be issued later this year under FSMA, affecting all domestic and international suppliers of food and food ingredients.

The regulations “will be more than adequate to ensure the accurate identity and quality of all food ingredients, including those used in supplements," McGuffin said.

The Organic & Natural Health Association (ONHA) is a recently formed trade organization that met with Schneiderman’s office and submitted the petition last month to subject ingredient suppliers to supplement cGMPs. It claimed FDA’s current regulations are inadequate.

“Under the existing regulations, dietary ingredient suppliers have no regulatory obligation to manufacture or hold dietary ingredients in accordance with the specific production and process controls that are necessary to ensure finished product quality," Todd Harrison, counsel to ONHA and the organization’s president, wrote in the petition, “and absent contractual obligations, dietary supplement manufacturers and consumers have no recourse against such suppliers that fail to manufacture quality product."

ONHA announced plans to submit the petition to FDA after meeting with Schneiderman’s office in April.

Fabricant is the former director of FDA’s Division of Dietary Supplement Programs. He pointed out it wouldn’t make sense to subject ingredient suppliers to certain cGMPs. For example, he noted it wouldn’t be necessary to establish a specification for the strength of a raw agricultural commodity if it is being processed into an extract at a manufacturing facility.

“Those are things that are really done at the manufacturing level," Fabricant said, “as they should be."