The Dietary Supplements Labeling Act was reintroduced by Senators Dick Durbin, D-Il and Richard Blumenthal, D-CT last year to require registration of all dietary supplements with FDA, and quickly defeated, but the topic remains a subject of conversation.
“We’re having conversations with our members about this, yes,” Mister told NutraIngredients-USA yesterday, “and considering the pro’s and con’s of product registrations, the feasibility, and what it means to the industry if there was such a requirement. As a positive, FDA says it doesn’t know how many products are out on the market, and this would solve that. But FDA would have to enforce this otherwise it’s an extra burden for the responsible members of the industry. It would also have to be a registration,” he stressed, “and the Agency would have no right to reject or challenge a product.
“It’s healthy for the industry to be having these conversations, but you have to ask if this is something the industry is ready for. CRN isn’t ready to suggest such an amendment nor are we ready to call on Senator Durbin to say we’re ready for it.”
DSHEA at 20
With DSHEA celebrating its 20 Anniversary this year, a lot of attention is being given to the act. “With hindsight, we could tweak this and that in DSHEA, but I think those issues are minor,” said Mister. “The big picture is that DSHEA has served the industry very well. It strikes a balance between consumer access and information about products and creating a framework for manufacturers. We’ve seen an explosion in growth in the industry, and the industry has a very good track record. The industry growing and outpacing retail growth.
"If you look at our industry in terms of a human lifespan, we’ve just gone through adolescence. We need to now think of ourselves as responsible adults."
Mister noted that DHSEA has been amended three times over the years, the first time being in 2006 for the adverse event reporting (AERs). “This was one piece missing from the original law, which gave the FDA the opportunity to remove a product from the market if there was a problem, but no was to monitor the problems, but AERs solved that.”
The other two amendments involved certain aspects of the OTC prescription drug legislation and FSMA, which impacted DSHEA on an ingredient level.
“There’s a political risk any time you open the act, and you have to be sure the critics cannot amend it. You must negotiate from a position of strength."
‘Strong’ is a word Mister uses often. At the CRN Conference last year, a rousing speech challenged companies to decide where they stand, who they stand with, and then take a stand.
This tale of two industries has become the mantra of CRN, he said, and he has used it in every speech he has given since then. “It continues to drive our thinking,” he said. “The FDA will not be strong enough, so CRN and the industry need to do more.
“It was a signal change to the industry that we are not going to apologize for bad behavior anymore. We’re going to call it out.”
Changes at FDA
Questions hang over the current strength of the FDA considering the sizable holes that need to be filled following the high profile departures of Dr Dan Fabricant and Dr Corey Hilmas to join the Natural Products Association.
“Corey brought a real element of taking the statute seriously, of wanting to see it succeed and enforcing against that,” said Mister. “It is important that FDA fills those necessary positions, and fills them with the right people.”
NPA’s new leadership, UNPA’s new focus on state chapters, and changes at AHPA have led to increased focus on the associations. For CRN, however, it is business as usual. And business has been good, particularly since introducing a new dues structure last year, a strategy that has “reaped huge rewards”, said Mister. The association now recognizes four categories of voting members: Branded finished product manufacturers, contract manufacturers, ingredient manufacturers, and ingredient representatives/distributors. Each category has different dues rates to reflect their relative business models and profit margins. “We are bringing in members at a rate that I haven’t seen since I’ve been with the organization.”
In response to calls for a return to a trade association coalition, Mister said that he doesn't think it’s necessary at this stage. “We have been working very well together over the last three years, with monthly meetings allowing us to share intelligence and coordinate efforts.”
The association is also dedicating attention and resources to initiatives at the state level. “State legislation continues to be a source of innovation and a source of problems. It can create issues that affect all of us.”
Initiatives in California to introduce country of origin labelling for ingredients and labeling of GMOs have both been opposed by CRN. On the latter, Mister said that CRN does not think the GMO labeling issue will be solved at the state level.
Mister, who spent 12 years working in state-level government affairs at the CHPA prior to joining CRN, said that one of the first speeches he gave at CRN nine years ago was about the threat that states pose to the industry.
Ingrid Lebert, director, government relations, CRN, who oversees CRN’s efforts in the states, added that paying attention to issues in the state legislatures is critical to the association's robust government relations agenda. "We’re building relationships not only on Capitol Hill, but with lawmakers in the states," she said. "Connecting CRN members with their representatives helps to illustrate the significant health and economic impact of the dietary supplement industry.”