The dietary supplement industry is preparing to dig up marketing catalogs, sales records and other documentation that dates back to the 1990s.
The reason? In a new dietary ingredient (NDI) draft guidance released last month, FDA expressed a willingness to develop a list of grandfathered ingredients that are exempt from a safety-related notification requirement in the Dietary Supplement Health and Education Act (DSHEA).
FDA revealed in the draft guidance it is “prepared to develop an authoritative list of pre-DSHEA ingredients based on independent and verifiable data." However, FDA noted the dietary supplement industry would need to provide marketing materials to support the list since the agency “does not generally have access to marketing records for dietary ingredients and dietary supplements."
But at least one industry leader acknowledged challenges in assembling a comprehensive catalog of dietary ingredients that were marketed before Oct. 15, 1994—the cutoff date specified in the law—and that FDA will accept as authoritative.
“We have been collecting old documents for years, so we may have a higher level of enthusiasm given the amount of stuff that we have," said Loren Israelsen, president of the United Natural Products Alliance (UNPA), in a phone interview. “But as FDA notes, you need to get permission from the holder of that information. And that is a huge question. Twenty two years have passed, so if there is a company that was around for years, now out of business, nobody to call or talk to, how do you get permission to use an old catalog?"
During a recent webinar on the NDI guidance for UNPA members, Israelsen also said manufacturing records that could dictate whether an ingredient is old or new may have been destroyed.
He described as “daunting" the task of developing a useful list of pre-DSHEA ingredients.
The list of pre-DSHEA ingredients that FDA will consider begins with substances that have been recognized as safe in the agency’s code of federal regulations, such as vitamin D, according to Daniel Fabricant, Ph.D., FDA’s former director of the Division of Dietary Supplement Programs who leads the Natural Products Association (NPA).
“That will be where I think the list starts," Fabricant said in a phone interview. “That’s not where it ends, but that’s where it starts."
He estimated FDA’s list includes 50 to 60 ingredients, reflecting just a fraction of the number of ingredients contained in industry-compiled lists.
“We’re going to have to have some discussions there on what exactly is a happy medium," he said.
Industry has already commenced the work to assemble a pre-DSHEA list of dietary ingredients. NPA, for instance, has renewed its call for industry to supply the organization copies of pre-DSHEA era industry magazines that may contain evidence (e.g., advertisements) of various ingredients that were marketed before the October 1994 cutoff date, noted Corey Hilmas, Ph.D., NPA’s senior vice president of scientific and regulatory affairs.
During an NPA webinar on the NDI draft guidance, an FDA official, Cara Welch, Ph.D., said the agency is hoping industry submits comments that include suggestions on how to develop an authoritative list of “old" dietary ingredients. Fabricant noted NPA has kept a number of old catalogs and newsletters with advertisements that could assist in the endeavor.
However, not all industry leaders are in favor of developing a grandfathered, or pre-DSHEA, list for public consumption. Enter Michael McGuffin, president of the American Herbal Products Association (AHPA).
“AHPA institutionally has never thought that was going to be a benefit to consumers or industry," McGuffin said in a phone interview. “I understand why FDA would see it as a value because they would then say everything else is new."
McGuffin expressed concerns that FDA would view absence of a record as evidence that the ingredient wasn’t marketed before October 1994.
“I do have a concern that if we … give them [FDA] a list of 200 Chinese herbs, they’ll say, ‘Ah ha, but we found 204 Chinese herbs in the market, so we hereby declare those other four as new or unsubstantiated,’" McGuffin said.
McGuffin said he once shared with FDA a 1990s-era marketing catalog to show that dietary ingredients had been sold in traditional Chinese products. But he recalled an FDA lawyer was quick to dismiss the brochure as a drug catalog hawking medical devices since the government lawyer noticed a listing of acupuncture needles that also were being sold.
“I’m skeptical that the agency wants to find supportive references," McGuffin explained. “I would need to hear an entirely different understanding of the value of our catalogs before I would even consider submitting them," he continued later in the interview.
Still, McGuffin said he is willing to help his members assemble pre-DSHEA documentation. He said he has saved a “rich record" of documents that include information on hundreds of botanical substances—and possibly approaching 1,000 total ingredients including minerals and vitamins—which could be used to refute accusations that the dietary ingredients are new.
While McGuffin acknowledged some AHPA members favor the idea of a grandfathered list, he said they tend to be new to the herbal business and don’t have their own records.
“What I always tell them is, ‘Call me. I’ll get you the information,’" he said.
FDA first issued NDI guidance in 2011, but the industry argued the document was inconsistent with DSHEA. Certain items in the revised 2016 guidance, including the notion of a pre-DSHEA list, demonstrate FDA “is taking what we have to say seriously," said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), in a phone interview.
George Pontiakos, CEO of ingredient manufacturer BI Nutraceuticals, also welcomed a grandfathered list. He indicated a number of botanicals have been proven safe with a history of use stretching back hundreds of years.
Now, the industry just has to prove it to FDA.