The potential chilling effect on access to supplements has industry leaders asking retailers to get more involved with the U.S. Food and Drug Administration’s New Dietary Ingredient (NDI) draft guidance. “This could have a significant impact on both products that are currently out there and the innovation stream of products that would likely be coming down the road,” says Steve Mister, president and CEO of the Washington, D.C.-based Council for Responsible Nutrition (CRN).
The guidance indicates that if an ingredient wasn’t on the market in the same form as in October 1994, the manufacturer will need to submit an NDI filing with FDA. “We’ve always known that if you brought a new ingredient to market, that would trigger the NDI requirement,” Mister says. “But this now goes beyond that and says, 'If it’s an old ingredient, and it’s being manufactured in a new way, then you’ve also triggered the requirement.' It’s much more inclusive.”
As draft guidance, the document does not establish legally enforceable responsibilities—yet. “This draft guidance will only secondarily affect retailers, and no one most likely will realize an immediate change,” says Cara Welch, PhD, vice president of scientific and regulatory affairs for the Washington, D.C.-based Natural Products Association (NPA).
The FDA has set a 90-day comment window for the draft. After that period, if manufacturers struggle to bring products with new dietary ingredients to market, retailers could face spotty coverage in their supplement aisles. "It is impossible to guess the number of NDI filings that could be required," says Scott Steinford, president of nutritional ingredient supplier ZMC-USA. "I have heard estimates that 65 percent of current consumer offerings could be subject to NDI filings. Extrapolating this figure out, the store shelves could conceivably become quite sparse if the worst case interpretations of this guidance are realized. Consumers will not allow this, and it is doubtful the FDA will want that type of burden as well."
Since the draft guidance’s release, the industry forecast has been gloomy, but there’s some hope on the horizon—that is, if everyone pulls together. “Some have said [the NDI guidance] would be the end of the U.S. economy,” says John Gay, executive director and CEO of NPA. “It sounds a bit dire. We’ve always said it could be a game changer for the industry. But keep in mind that it’s draft guidance, and we have a chance to respond as an industry. We all should take advantage of that.”
The role of the trade association in the NDI process
But how can retailers and others vested in the supplement industry get involved?
“The best way for industry to gather together [for the NDI process] is through a trade association,” Gay says. He notes that these groups can effectively act on industry issues, but more players need to get involved and voice their opinions. Even if you add up the members of the top five natural products trade associations—CRN, NPA, United Natural Products Alliance (UNPA), American Herbal Products Association (AHPA) and Consumer Healthcare Products Association (CHPA)—the total doesn’t represent all of industry, Mister says.
Of these key groups, only NPA caters to retailers as well as other industry members. The remaining groups primarily serve natural products manufacturers and suppliers.
As the largest industry organization, the NPA boasts 1,900 members, 1,200 of which are individual retailers. Another retailer network, the Minneapolis-based Independent Natural Food Retailers Association (INFRA) has steadily grown in membership since its inception in 2005. The group added its 100th store location in May.
While association growth is good, retailer participation in industry trade groups could stand to improve considering that there currently are about 36,050 independent and specialty natural products stores operating in the United States, according to NFM's 2011 Market Overview.
What can retailers do?
“Retailers as well as manufacturers need to become more engaged in this process,” says Mister. “They need to defend what they have.”
Retailers stay busy enough with daily shop upkeep. Getting involved in political issues can sometimes feel like an extra, albeit necessary, burden. “As much as we would like to just ‘mind the store,’ we have found we do not have a choice but to actively engage legislators and regulators at the local, state and federal level,” says Alan Lewis, director of government affairs for Boulder, Colo-based Natural Grocers by Vitamin Cottage.
The good news: There’s time to get acquainted with and involved in the NDI process. “Given that it’s draft guidance and the comment period goes until early October, we have some time to get it right, to consider the potential impact it will have and what to do next.” Gay says.
Industry associations aim to help retailers and other industry members learn more about the guidance and offer feedback. The NPA held a webinar entitled “NDI Guidance: What You Need to Know” on July 11. If you missed the event, you can go to the NPA website in the next week to order a CD of the webinar, including slides, draft guidance and other materials. Members will receive a discount on this package.
In addition, retailers can do the following:
Put pressure on manufacturers.
Mister recommends that retailers encourage their vendors and suppliers to join a trade association, which serves to protect the future of the industry. “If I was a manufacturer, and I [received pressure to join a trade association] from 20 of my customers, that would be a wakeup call for me to investigate a trade association,” Mister says.
Submit comments to the FDA.
You can submit comments on the NDI draft guidance at www.regulations.gov. Or, you can write to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, RM. 1061, Rockville, MD 20852. Comments are due by October 1.
Offer feedback to the NPA.
The NPA will call on members to submit their thoughts on the draft NDI guidance. Then, the NPA will compile these comments into a unified association response.
Join NPA’s grassroots network.
By registering for the NPA’s Action Alerts at the organization’s website, you’ll receive email notices when it’s time to make a difference on the NDI issue and other critical industry matters.
Rally fellow retailers.
The Independent Natural Food Retailers Association has a member-only listserv that you can use to communicate with other retailers about the NDI issue and to unite for any necessary action. On other issues, the listserv has been a powerful tool. For example, INFRA members are known for their strong stance against genetically modified organisms. Thus far, they have donated more than $55,000 to the Non-GMO Project, and this outpouring of support was an outcome of communication that began on the INFRA listserv, according to Dot Peck, director of programs for INFRA.
Alan Lewis of Natural Grocers says his biggest allies in political efforts are his customers. “We ask them to speak loudly and often to protect their freedom to use dietary supplements and eat safe organic food,” Lewis says. “These choices are not guaranteed and are always threatened, so shopping with us sometimes may seem like a political statement. Often, it is.” To engage your customers, you can create informational handouts or hold education sessions about NDIs and the guidance's potential impact on access to supplements. Or you can simply chat with customers about the NDI issue—and how they can submit comments to the FDA—when they enter your supplements section.
Additional reporting provided by Caren Baginski, Carlotta Mast and Hank Schultz.