Earlier this year the US Food and Drug Administration unveiled its Supplement Your Knowledge educational resource aimed at consumers, educators and healthcare professionals. It is a website that contains documents in both English and Spanish as well as educational videos.
Steve Mister, CRN’s president and CEO, said while his organization applauds FDA’s effort to provide targeted educational opportunities for key stakeholder groups, the resource as it stands contains some inaccuracies and missed opportunities.
CRN’s reservations in nutshell
CRN’s main issues with the information on the site can be summarized thus:
- Overstates the potential risks of taking supplements while downplaying benefits
- Misses opportunities to address public health issues with responsible supplement usage
- Does not communicate the robust regulatory framework in place that gives the agency
- authority over dietary supplements, leaving a misimpression that the regulation is inadequate
- Could be enhanced by collaboration with the dietary supplement industry through CRN in developing future messaging.
Bias continues, even if the originators of that view have gone
Mister noted that in the early days of the modern dietary supplement industry, shortly after the passage of DSHEA in 1994, there were some personnel at FDA who were mistrustful of the newly created product category. That seemed to color the view of the entire Agency, and it has been an uphill battle ever since to get agreement on whether the sector is properly regulated. That message seems to have persisted within the Agency, even if some of the key figures in that narrative have moved on.
“I think there were some people in the industry who had hoped that this bias in the Agency would take care of itself, one retirement at a time. But it has been 28 years since DSHEA and it has been continuing,” Mister told NutraIngredients-USA.
FDA asked CRN to put concerns in writing
CRN voiced its concerns via a letter sent to the Agency in mid September. This followed a Zoom meeting with Cara Welch, PhD, head of FDA’s Office of Dietary Supplements, in which she suggested CRN put its reservations in writing so she could direct them to the right people within the Agency for consideration.
“We thought it was important to call it out, and sometimes that might make people take a step back and reconsider. We thought it might cause the Agency to self correct,” he said.
Mister said the notion of risk associated with supplements in particular was overemphasized throughout the materials on the FDA site. That gives the impression of a problematical, potentially harmful category of consumer products over which FDA has insufficient authority to safeguard public health.
For example, when discussing cosmetics, FDA said these products “do not need FDA approval before they go onto the market.” To communicate essentially the same message for supplements, the Agency used this language: “FDA is not authorized to approve dietary supplements for safety and effectiveness before they are marketed.”
In another instance, a presenter on one of the videos is quoted as saying, “Staying safe when you’re taking dietary supplements might seem challenging.”
FDA also does not acknowledge that the 2020-2025 Dietary Guidelines for Americans identifies numerous nutrients where low intakes are associated with health concerns. Despite ample research that shown that some dietary supplements could be helpful in avoiding these shortfalls, there is no mention of this in the materials. In the portion of the materials aimed at educators, CRN noted, the benefits of supplements are mentioned 15 times, whereas the risks are mentioned 65 times.
And, Mister said while the website materials harp on the lack of a premarket approval mechanism for supplements they fail to mention the GMP requirements that supplements must meet, which in some ways are more stringent than the laws covering food manufacture.
Adverse events data mischaracterized
CRN also took issue with the way in which the serious adverse event reporting system—a requirement which after all the industry itself pushed for—is presented. In the trade organization’s view, FDA characterizes adverse events as much more prevalent than they actually are. The Agency chose to highlight a few frightening—but very unlikely—examples.
“Supplements are meant to be used regularly by the general population. You go into looking at supplements with the expectation that there should be no adverse events,” Mister said.
“What I do think is important is the number of adverse events versus the denominator. In that way supplements have a great story to tell on just how safe they are versus the billions of times they are ingested by American consumers,” he added.
CRN’s 11-page letter to Welch includes numerous line-by-line critiques of the website’s language with suggestions for improvements. No Federal docket has been opened by FDA for feedback on the educational resource (and FDA is thereby not formally required to respond), but CRN ask FDA to “Please let us know the best way to move forward in that direction if there are specific contacts in the agency’s communications or education departments our staff should reach out to directly.”