ACI Dietary Supplements Regulatory Forum: A ‘new’ FTC, changing Supplements Facts panels, and navigating retailer demands
The forum was hosted by the American Conference Institute and the Council for Responsible Nutrition (CRN), a dietary supplement industry trade group.
Steve Mister, president and CEO of CRN and co-chair of the event, opened with a quick update of the political and regulatory climate for dietary supplements.
“These days when you think of Washington, probably the first words that come to mind are chaos, and disruptiveness, and I think that only tells half the story,” he said.
“All of that is absolutely true, but then there’s another layer down beneath the front page issues that we see that continues to function, and fortunately for dietary supplements, that’s where we are, and let’s hope we stay that way.”
Mister also introduced the current five commissioners of the FTC, who oversee so much of the industry’s claims.
The new commissioners seem to focus more on antitrust, financial services, and privacy—issues that don’t really effect the dietary supplement industry, Mister said.
He also added that the current FDA commissioner, Scott Gottlieb has a “pro-business agenda.”
“He wants companies to innovate, he wants to give companies the freedom to grow and expand in the context of consumer safety.”
Get to know your elected officials, starting at the local level
Engaging with agencies, policymakers and other elected officials is something companies big and small should do, said Kristen Blanchard, vice president of external corporate affairs at the South Carolina-based Nutramax Laboratories.
And it’s not just about mingling in DC. “Many congressmen and senators start local, so you should get to know them then,” she told the audience. This could be anyone from the mayor to the superintendent of the parks and rec department.
She encouraged attendees to not wait around until crisis hits, or when a legislation is proposed that may negatively affect business.
Corporate social responsibility is one way companies can show that they are actively interacting and committed to the community. Companies can also invite local officials to tour their facility, and it doesn’t have to be tied to a specific ask either.
“When you invite them to your facility, they’ll be interested—they have their constituents there.”
Don’t expect an ODI master list. ‘Not a good use of agency time and resources’
When it comes to filing New Dietary Ingredient notifications to the FDA, (Do I need one if I mix this ingredient with an excipient? Or will this manufacturing process make an ingredient require one?), there’s still a lot of confusion in the industry about what to do—a theme reiterated by many speakers during the conference.
Keynote speaker Robert Durkin, deputy director of the Office of Dietary Supplement Programs at the FDA said that high rejection rates in 2017 were largely due to notifiers that shouldn’t go through the process in the first place.
More news from the forum
The dietary supplements industry is no longer the 'dietary supplements industry,' expert opines
The industry needs to embrace a larger functional food platform, said Scott Bass, partner and head of global life sciences at Sidley Austin LLP, during his opening remarks as co-chair of ACI’s Sixth Annual Legal, Regulatory and Compliance Forum on Dietary Supplements in New York last week.
This has included ingredients for topical use, and even fully formulated finished products in which the notifier, instead of characterizing a product or ingredient, wrote as an answer to every prompt and question that “a retailer is requiring me to do this,” Durkin said.
Another speaker, Miriam J. Guggenheim, partner and co-chair of the food, drug and device practice at Covington & Burling LLP, said that a popular question she gets from industry clients around NDIs is whether or not an ingredient can be classified as ‘old.’
Despite lobbying from trade associations, Guggenheim said an ODI list from the FDA won’t likely happen.
“My predictions is that, despite the attention, this is too big a bridge to cross at this stage,” she said.
“And with the absence of significant safety concerns, this distinction doesn’t seem to be either a major priority for FDA at this time or a good use of the agency’s resources, so I’m not holding my breath for an ODI list.”
A new Supplements Facts label (and USDA updates)
The FDA’s deadline for companies to comply to the new Nutrition Facts and Supplement Facts labels was extended from July 2016 this year to January 1, 2020.
According to Jena Rostrofer, associate director, regulatory at Abbott Nutrition, the FDA stated that the Supplement Facts label is not going to change substantially.
“The format of the panel is likely not the topic of intense discussion at your companies,” she said.
“But my guess is that some of these changes in the nutrient guidelines, in this instance the science behind the label, is creating quite a bit of dialogue in decision making in terms of whether you will adapt consumer messages or claims on pack, or change your formulation in order to keep the messaging.”
An example is the update to Dietary Reference Intakes (DRIs) and Daily Values (DVs)—some are going up, while others are going down.
With vitamin D, classified as a ‘nutrient of public health concern’ by the FDA, brands that currently position their products as meeting 100% of DV will have to double fortification to keep that messaging and comply with the new Supplements Facts label requirements.
In the prenatal category, the DV of folate is currently 800 mcg per day folic acid. But under the new rule, the DV is reduced to 360 mcg per day.
A patchwork of ‘retailer initiatives’
In another session, panelists talked about the post-NY AG investigation landscape, and the many different retailer initiatives that was born out of the scandal.
This includes retailer-driven testing and verification programs like UL/WERCSmart, the Supplement Safety & Compliance Initiative (SSCI), Global Retailer & Manufacturer Alliance (GRMA), and a relatively new CVS-NSF testing program.
Other retailer initiatives include Whole Foods and Amazon requirements for third-party gluten free and non-GMO certification (only if a company wants to put the claim on pack—so it’s either an allowed third party certifier, or no claim at all).
Attorney Rend Al-Mondhiry, senior counsel at Amin Talati Upadhye, reminded that working with different retailers could mean a company needs to go through duplicative, redundant testing, and she emphasized that manufacturers and retailers should keep confidentiality of data and test results, as well as intellectual property, in mind.
According to Melissa Hung, senior corporate counsel and director at The Clorox Company, the patchwork of initiatives is “the biggest practical risk for in-house counsel teams.”
Some tips she offered included setting time to address program details at the outset, while negotiating with retailers and partners. She also suggested building retailer requirements into company’s internal processes and standards.
