State AGs Out Of Their Bailiwick Testing Supplement Ingredient Identities

State AGs can determine whether a supplement label makes an unsubstantiated claim, their previous litigation target, but they aren't qualified to test ingredient identity, says Doreen Manchester in a FDLI presentation on state agencies' enforcement.

Settlements with state attorneys general for testing or disclosures not standard in the dietary supplement industry exposes other firms to the same requirements while also ceding authority about science to agencies unprepared for it, says food and drug law attorney Doreen Manchester.

New York Attorney General Eric Schneiderman's investigations and charges in 2015 against supplement firms and retailers about herbal supplements not containing the ingredients listed on labels signaled a shift in what states' AG offices are focusing on when they target products and firms in the space.

However, while officials in state AG or similar agencies likely are capable of determining whether a supplement label includes an unsubstantiated claim – previously the typical litigation target – they aren't qualified to test the products' ingredients, said Manchester, of Washington firm Venable LLP, on Sept. 15 at a Food and Drug Law Institute conference.

"AGs delving into a scientific world, and I am little biased, they generally know nothing about is dangerous, I think, to the industry," she said.

A supplement manufacturer might consider settling to avoid litigation costs when facing a complaint from Schneiderman or another state AG, but another question should be considered, Manchester added.

"Should AGs be the ones that are evaluating your science? They can evaluate your science and say your science isn’t good enough or say your science is bad and not saying what you want it to say," she said.

"You're kind of stuck with the investigation. Your only resource there is to not settle with an AG and do some litigation where you can challenge the AG's [testing] method. Get your own experts, have your battle of the experts and challenge the methods the AG used. That's costly."

Our supplement industry coverage is compiled this page of The Rose Sheet website.

In March 2015, less than two months after Schneiderman's office announced charges concerning sales of adulterated supplements against [GNC Holdings Inc.] and three mass-merchandise retailers, GNC agreed to settlement that did not impose a fine, but required the firm to use DNA barcoding for identity testing in ingredients used in products marketed in the U.S. When barcoding references on certain plant materials GNC would use in its Herbal Plus products are unavailable from a public domain source or a third-party vendor within 24 months, the firm will contribute those barcodes and its methods to identify them “to a publicly accessible database." (Also see "GNC Targets ‘Consumer Trust’ In N.Y. Agreement, But Industry Wary Of Impact" - Pink Sheet, 15 Apr, 2015.)

Using DNA barcoding in ingredient identity testing likely would be more reliable on source materials than on finished herbal products because botanical materials show little to no DNA after processing for use in a supplement or other product. However, experts also say insufficient data references are available to reliably use DNA barcoding on source botanicals.

"When you test for the DNA you may not finding anything. It's not surprising to a lot people in the industry that the products that were tested, a lot of the products, came up with a no match," Manchester said at the conference in Washington.

'Shocking' So Soon

On the other hand, GNC's agreement to settle two months after the New York filed a complaint surprised her.

"What's shocking about Schneiderman's investigation is that … he started the investigation in February 2015 and [GNC] settled at the end of the March 2015. … So, two months in they settled which could have been to avoid fines, but we don’t know," Manchester said.

Former GNC CEO Mike Archbold, in an interview earlier in 2016, said he opted to settle partly because Schneiderman's staff was not familiar with FDA's regulation of the industry in the framework established by the Dietary Supplement Health and Education Act.

Schneiderman and other state attorneys general followed up with requests to Congress and FDA for broad changes to impose more stringent requirements on supplement manufacturing and marketing, neither lawmakers nor the agency have suggested changes.

The AGs "basically asked for a huge overhaul of the dietary supplement industry," Manchester said, adding, "It's not surprising it hasn't gone anywhere."

Supplement firms shouldn't expect that state agencies have eased up on their scrutiny of the industry, though.

"It's a very broad array of powers that they have and they can investigate almost anything," Manchester said.

And the agencies multiply their powers by cooperating. "They call each other up and talk about what they're investigating. A lot of them just join on to others and then it's easy for AGs to follow on to another AG's investigation, especially if that state is going to do all the work."

In addition to New York, others on a list of "who to fear as far as states and AGs" are Connecticut, Oregon and Vermont, Manchester noted. Typically, agencies with a staff member interested in scrutinizing a certain industry or type of goods will investigate in those areas.

She pointed out that Connecticut AG George Jepsen in June was elected president of the National Association of Attorneys General. Jepsen's initiative as president, “Evolving Challenges in the American Health Care Marketplace: Competition, Cost and Innovation in a Rapidly Changing Industry,” seems to move the supplement industry out of his bulls-eye, but Manchester suggested firms remain vigilant about state agencies.

"I don’t think that anyone is safe. I think that everyone has to take measures to prevent investigations if you can, which is almost impossible. That usually would mean closing your doors and not selling anything," she said.

From the editors of The Tan Sheet. Our dietary supplement industry coverage now is published in The Rose Sheet, with articles emailed to readers daily and available on this page of The Rose Sheet website.