Supplement Industry Outreach To State Officials Pays Off – Former Maryland AG

State attorneys general largely are discriminating good from bad supplement industry actors, says former Maryland AG Doug Gansler following the annual meeting of the Western Attorneys General. State officials' brighter take on supplement firms stems from industry outreach and education efforts.

Explaining the dietary supplement industry and its products to state officials is paying off, former Maryland attorney general Doug Gansler says following discussions about supplement manufacturing at a recent meeting of states' attorneys general.

A majority of officials at the 2016 Conference of Western Attorneys General in Sun Valley, Idaho, July 17-20, gave personal votes of confidence for the industry as Gansler pointed out they acknowledged they supplement their diets with vitamins, minerals and other nutritionals.

“There was also a powerful moment when [a speaker] at the meeting asked for a show of hands of people who take dietary supplements,” Gansler, who represents the American Herbal Products Association and the United Natural Products Alliance to states officials and Congress, said in an interview.

Gansler, also a partner at the Washington office of Buckley Sandler LLP and a former National Association of Attorneys General president, attended a nutritional supplement panel at the meeting hosted by Colorado AG Cynthia Coffman on topics including manufacturing and ingredient quality.

He said the discussion showed many AGs are acknowledging the industry predominantly comprises good actors and is not an unregulated milieu of suspicious businesses that abuse consumers' trust and endanger their health.

“I think over time, the dialogue has shifted from one where the conversation was driven by uninformed folks that wanted to criticize the industry to a discussion of the fact that, like any other industry, the lion's share of [companies] in the industry are trying to do good things and are doing good things,” he said in an interview.

The brighter perception largely is due to education efforts and outreach of individual firms as well as AHPA and other trade groups to state officials and members of Congress on the integrity of the majority of supplement manufacturers, suppliers and marketers.

'Hot Spot' For State Action

From input at the conference, Gansler said AGs overall view industry firms as “operating within the confines of several statues that regulate them, but there are going to be a couple bad apples. They need to be identified and their products off the market.”

However, certain states remain “regulatory hot spots” – Hawaii, New York and Oregon, and according to AHPA.

Oregon Attorney General Ellen Rosenblum filed a complaint October 2015 alleging [GNC Holdings Inc.] violated of the state's Unlawful Trade Practices Act by selling supplements containing picamilon and BMPEA, ingredients that FDA had advised supplement firms not to use. GNC contends the lawsuit is based on false allegations since it, like other firms, pulled the products when FDA’s warned the substances were violative. (Also see "Regulatory Roundup: Oregon Targets GNC In BMPEA Complaint, Spiked Products In Imports" - Pink Sheet, 20 Oct, 2015.)

Gansler said Oregon Assistant Attorney General David Hart also is aggressively targeting supplement manufacturers.

Hart "has literally and figuratively taken dietary supplements to heart and is spearheading a lot of the cases from the state side against companies in the dietary supplement space," he said.

Hawaii has the distinction, he added, of being the home of many of the “bad apple” companies that manufacture noncompliant products.

At the CWAG meeting, Hawaii AG Doug Chin stated concern over what “assurances” state officials can have that products provide their claimed benefits, according to AHPA.

Industry should continue education efforts, says Gansler. Firms can ask trade groups to facilitate formal invitations to host a visit by a state AG, he said.

But companies that host AGs should be careful to appoint the right person to host the tour. Gansler said some employees on the business side are at a disadvantage without the assistance of manufacturing and research staff with more knowledge about a facility and its processes.

“Make sure you have the right person,” he said.

Industry also has stepped up efforts toward transparency, addressed “shortcomings” and responded to demand from some regulators for increased self-regulation, AHPA noted in a release summarizing highlights of the CWAG meeting.

Industry groups remain steadfast that the Dietary Supplement Health and Education Act gives FDA adequate authority to prevent firms from marketing products labeled as supplements that contain pharmaceutical or other non-dietary active ingredients. Industry has taken steps, however, to improve visibility into their operations and ensure the public that their products are high-quality.

In April, GNC released its internal guidelines, including requirements for suppliers and vendors, across the industry as a model for ensuring the supply chain, testing and manufacturing practices for supplements remain strong. The manufacturer and retailer also added AHPA's good agricultural practices to its guidelines.

Difference A Year Makes

The improvement is a big change from the first half of 2015, when AGs in numerous states scrutinized the industry following New York AG Eric Schneiderman’s allegations that GNC and several big box retailers sold herbal supplements in the state that did not contain the ingredients stated on labels.

Following a March AHPA conference on state crackdowns on supplement makers and marketers, Gansler discussed a domino effect from Schneiderman's action. Although industry responded effectively to the New York complaint in pointing out that the DNA barcoding Schneiderman's investigators used did not work to identify ingredients in finished herbal products, the AG won in the court of public opinion, Gansler noted during an AHPA webinar.

AGs in other states became suspicious of manufacturers and a perception grew among them that the supplement industry is not regulated. As state agencies have more nimble regulatory authority and can more quickly and efficiently to go after supplement firms for violations, those misperceptions pose challenges for companies in their home states, Gansler said.

Since tapped to work with AHPA and UNPA earlier in 2016, Gansler has encouraged supplement companies to reach out to state AGs and show the industry's efforts to ensure supplements are safe and are being developed through good manufacturing practices. He also advised companies to invite AGs to tour their manufacturing facilities.

Industry largely has heeded the advice, AHPA noted in its release on the CWAG meeting. The trade group noted that during the meeting, Alabama AG Luther Strange offered a positive report on his tour of PharmaviteLLC's facility in Opelika, and Idaho AG Lawrence Wasden made similar comments about a tour of [Thorne Research Inc.]’s Sandpoint facility.

“The accolades made it clear that top-flight facilities are great ambassadors,” AHPA said.