FDA’s new dietary supplement office should focus on tainted products, GMPs & NDIs, industry leaders say

Likewise, the new office should invest any new resources it receives in hiring more specialized staff and technology that will open communication between the agency and industry, Council for Responsible Nutrition President and CEO Steve Mister and American Herbal Products Association President Michael McGuffin told industry and agency representatives May 5 at CRN’s inaugural Regulatory Summit in Washington, DC.

Mister explained to NutraIngredients-USA that the promotion of dietary supplement oversight from division to office was essential “if FDA is going to seriously regulate the $39 billion industry”​ that dietary supplements have become.

“Moving the dietary supplement division up to office status means that this part of the agency can now compete with other offices, such as the Office of Cosmetics and the Office of Food Additives for resources, for personnel and even just for attention within the agency,”​ Mister said.

But, he cautioned, the move alone is not enough. The new office needs to seize momentum and tackle major issues that weigh down the dietary supplement industry.

Setting an agenda for consumer safety​

“They have a lot of things that they have to address with their new office status,”​ he said. “One of them is overcoming the 22 years of inattention to the industry.”​

He explained to conference attendees that industry and FDA are working “against a lot of distrust”​ that stems partly from FDA’s failure to fully enforce the Dietary Supplement Health and Education Act when it passed in 1994.

“The reality is, there was a widespread perception in the industry that after DSHEA, for some period of it, it was pretty much pencils down and there was not a lot of implementation of DSHEA. It was almost as if it was on hold and there was an expectation within the agency that if they did not implement the law, the industry would implode,”​ Mister said, adding, “Well, that didn’t happen.”​

He is hopeful, however, that the industry-supported elevation of dietary supplements to its own office will allow the industry and agency to move past this history to tackle more pressing issues.

Top priorities:  tainted supplements & GMP compliance​

“Once we get past that big picture, we really need to see them focused on the tainted products -- the illegal products that are out there masquerading as dietary supplements because that is where there is the most risk to public safety,” ​he told NutraIngredients-USA.

“A close second priority,”​ he told attendees during the conference, is improving GMP compliance because that is another potential public safety risk.

“We have people who think they’re taking a product, but because of poor supply chain management they’re not getting the ingredients that they think they are getting,”​ he said.

Indeed, Steven Tave, current acting director for the Office of Dietary Supplement Programs, said at the conference that ensuring the integrity of product identity is a top agency priority, and that includes ensuring GMP compliance through enforcement and education.

He also chastised the industry for its current level of compliance with GMPs, which, he said is not where he thinks it should be after about 10 years of being in effect. He noted the agency continues to find too many basic failures, such as lack of specifications.

Mister told NutraIngredients-USA that he disagrees with the broad characterization of the industry as not doing well with GMP compliance, noting that “even FDA has admitted that the larger companies that have now, in some cases, been inspected two or three times, are doing quite well with GMPs.”​

However, he acknowledged, the industry does have problems with “pockets of the industry, particularly among the smaller companies that, quite frankly, have never taken GMPs seriously in the first place.”​

But, he stressed, that is not the majority of the industry and FDA could do “a lot more in the way of education around the GMPs for smaller companies.”​

McGuffin agreed on many of these points and added that the office should also prioritize publishing the revised NDI guidance.

Staffing and technology need bolstering​

Industry and agency officials are hopeful that with the elevation of dietary supplement oversight from division to office will come with additional resources, which McGuffin and Mister encourage the agency to invest in specialized staff and improved technology.

Specifically, McGuffin and Mister urged FDA to hire staff with expertise in herbals, nutrition, probiotics and experience working in industry.

Beyond hiring more specialists, Mister said the office should better leverage existing staff.

Focusing on there being only 22 people at the office “is underselling [the office’s] abilities because that does not count all of the district’s inspectors who are actually out there inspecting facilities. It doesn’t count the people in the Office of Chief Counsel, which does the enforcement action,”​ all of whom can help the new office advance their priorities, Mister said.

A permanent leader is essential​

He also emphasized the need for permanent leadership at the top of the office.

“When you have seven acting directors in over a period of three years, certainly none of those acting directors have the skin in the game, if you will, to do the kind of broad bold things that sometimes need to be done to move an agency forward,​” Mister said.

He added: “The industry is very eager to see someone put into that spot permanently so that they know that they have a long-term interest in this industry and that they have authority, if you will, to make some bold decisions, to use their leverage to get the NDI guidance out of whatever part of the agency that seems to be stuck in, and to really look at some of the claims issues and make some broad pronouncements about what is and is not legal. Those kinds of decisions require a permanent leader.”​

Industry should offer an “open hand”​ to FDA​

McGuffin and Mister realize this is a tall order for the new office, but they say the industry is eager to work with FDA to strengthen the agency’s position on dietary supplements.

“CRN is very eager to collaborate with his new office of dietary supplement programs. I think there are lots of ways that we can do that,”​ Mister said. “One is education with consumers – helping them be more aware of the risks of these tainted products and how they can steer clear of them when they're making purchasing decisions. I think we can work with retailers. We can help them identify the pockets in the industry where they need to do much more in the way of education.”​

He also noted that CRN is willing to help FDA by sharing information from its voluntary dietary supplement registry, which it is about to launch.

“FDA will, of course, be able to have access,”​ he said, noting it will bring the agency a new level of transparency. “The agency will be able to see products ingredients on labels in a way that maybe they haven't in the past.”​

Looking forward, Mister said he is optimistic about the new office

“We have been very encouraged with our initial meeting with the personnel at the new Office of Dietary Supplement Programs. I do think that there is a new interest in really trying to work with the industry to try and advance the regulations and ultimately to advance the public safety and health around these products,”​ he said.

With that in mind, he encouraged industry to respond to the new office “with an open hand to say we are willing to work with you, FDA….I do think there’s a lot of opportunity for collaboration and a new day and regulation and this could be the first step.”​