“Big picture: The important thing here is that the supplement industry has grown tremendously over the last 20+ years,” said DSQC Steering Committee Chair Christine Burdick-Bell, in an interview with WholeFoods Magazine. “The industry has literally grown 10-fold since DSHEA was passed.” That growth comes with issues that DSHEA didn’t anticipate, which haven’t yet been fixed—which is where DSQC comes in.
The Dietary Supplements Quality Collaborative (DSQC) exists to help support the industry in its pursuit of safe, quality supplements. Burdick-Bell explained that the Collaborative has a variety of stakeholders interested in this goal, ranging from trade associations like the Council for Responsible Nutrition and USP organizations, to companies like Pharmavite and retailers. “Our efforts are really policy-driven, to make sure that we have safe and quality supplements.”
These efforts are put towards goals including:
1. Mandatory Product Listing
The top issue: FDA doesn’t know what’s on the market. “There’s a lot of interesting supplements out there, but FDA doesn’t have all the tools it needs for this evolved marketplace that we’re seeing,” Burdick-Bell explained. “One of the biggest issues they’re having is that they don’t have good visibility in what is on the marketplace. So that huge size and lack of visibility allows adulterated and misbranded products to get into the marketplace. As an example, between 2007 and 2019 FDA tested a bunch of products, and identified 965 of them to include potentially hazardous substances. And that could just be a fraction of what they’re able to see. And there’s also a concern that these products are not being made in accordance with the GMPs, so there is a consumer safety issue here, and certainly a quality issue. So the FDA would really like to understand what is on the marketplace, and DSQC agrees with them.”
This would serve a couple purposes. It would provide FDA with greater visibility, first and foremost, and a better understanding of what’s on the market. “And once it’s a requirement,” Burdick-Bell noted, “if you don’t do it correctly, you have now violated the law, so now FDA has one more tool at its disposal.”
Nor is this a move that would only benefit FDA. “I think it’s important to realize that mandatory product listing will have benefits for retailers,” Burdick-Bell said. “They can identify products, what they contain, and that will allow them to have greater visibility. And when they’re thinking about what they want to stock, it’s an easy benchmark.” She maintains that if a company doesn’t even have their products on the listing, the company doesn’t understand or doesn’t follow the law, striking them from consideration for retailers.
Liz Richardson, Vice-Chair, told WholeFoods that there’s broad support for this movement. “90% of adults support a product listing, which held across party lines.” She said that this is due in part to the feeling that products on the market aren’t necessarily safe: “Once we’d explained it to them, 70% of consumers felt that FDA’s oversight isn’t good enough. It only allows FDA to review safety after a product is on the market.”
As Project Director, Health Care Products, at Pew Trusts, Richardson wrote an article about a Pew survey noting that even among those who are skeptical of government regulations, 87% of those surveyed backed mandatory product listing. The survey also found that 1 in 8 adults said that they or an immediate family member had experienced a severe side effect from a supplement. There’s an opportunity here for natural products retailers to make themselves a necessity for consumers: “Most consumers think retailers should bear some responsibility for the safety of supplements they sell, but feel that retailers don’t know if those supplements are safe,” Richardson told WholeFoods. “They do feel that manufacturers and FDA definitely also have responsibility, but that retailers do have a role.” Communicating to customers that you vet your supplements carefully, and being able to answer questions in-store, can make you the trusted source that customers want.
Related: ICYMI: Mandatory Product Listing: Beneficial, or Burdensome?
FDA Warns 2 Companies for Misbranding Pain Relief Products Containing CBD
Modernizing Regulations for a Safer Dietary Supplements Industry
2. FD&C Act Revisions
The second major issue DSQC is focusing on is this: There are unsafe products out there that FDA can do nothing about.
“If you look at the FD&C Act,” Burdick-Bell explained, “you have two different kinds of products: food and drugs. And supplements are under foods. But drugs specifically includes products intended to treat, cure, or prevent a disease. So if you have a product that contains a drug substance, it isn’t a supplement and can’t be handled as such—but if that product also doesn’t make a claim about treating, curing, or preventing disease, then the feeling is that it can’t be handled under the drug side. Therefore, FDA has looked at its own statutory authority and has concluded that, for products masquerading as supplements that contain illegal drugs, it doesn’t have enforcement rights, including the power to mandate a recall. This is a major loophole. I know that DSQC feels strongly that if it’s labeled as a dietary supplement, it should be treated as such.”
Richardson noted that DSQC recently sent out a letter to the Energy and Commerce Committee about this illicit substances loophole, looking to raise the profile of this issue. DSQC has also had Hill briefings in the past, trying to bring attention to these issues.
CRN, too, is taking action. According to a press release, the association announced its support for revisions to FD&C Act that would clarify FDA’s authority over products masquerading as supplements, regardless of their contents. The proposed legislative language creates a new prohibited act, the ability to exclude imports, and the ability to seize any product labeled as a dietary supplement that fails to meet the definition of a dietary supplement.
“If a product is branded or marketed as a dietary supplement, then it should be held to account as if it was a dietary supplement,” said Julia Gustafson, VP, Government Relations, CRN. “CRN and our members want to get rogue and illegal products out of the supplement market, as they jeopardize public health and hurt consumer confidence in the responsible industry. If enacted, these amendments will provide concrete steps towards building a safer supplement market and a more effective FDA. Products marketed as supplements should be held to the requirements and restrictions the FD&C Act imposes on this class of regulated products, and should be subject to the enforcement tools that law provides, like seizures, mandatory recalls and criminal prosecution. CRN agrees that FDA needs these enforcement clarifications, and calls on Congress to enact these amendments to the statute to protect consumer safety for the three quarters of Americans who rely on these products to support their health and wellness.”
3. Quality Control Benchmarking
Burdick-Bell points to an issue that manufacturers face: retailer quality control programs. “Retailers have a really important role as gatekeeper, making sure that consumers who come to the retailer have safe quality products. When they see new brands and products, I think some of the things we’ve just talked about will help them play gatekeeper. And we’ve seen retailers do more self-policing, rolling out more quality standards. The programs, however, are often developed without meaningful input from manufacturers, can be duplicative, can be inconsistent, can limit access to affordable supplements. Retailers should partner with key stakeholders to make sure their programs are tailored to address the concerns they have. GRMA [Global Retailer and Manufacturer Alliance] is already partnered with DSQC to help retailers and other key stakeholders achieve a safer marketplace.”
How can retailers help? Making use of established quality control programs, as mentioned above, to keep shelves stocked with safe supplements. Calling members of Congress to make it clear that this is an issue that matters to you, too, can help, the experts note. And retailers looking to get more involved can become part of DSQC themselves. More information on the Collaborative can be found here.