Upgrading Dietary Supplement Programs On Org Chart Catches On At FDA

Sources say FDA submitted to HHS a proposal to make its supplement programs division an office within CFSAN. CRN’s president also says the industry should stop sales to consumers of bulk powdered caffeine, a change FDA doesn’t need additional resources to enforce.

Industry trade groups’ suggestion that FDA upgrade its dietary supplement division to an office appears to gain traction at the agency and could soon be forwarded to Congress, which would have 30 days to register any objection.

“We know that the FDA has been very receptive about that,” said Steve Mister, president and CEO of the Council for Responsible Nutrition, one of the groups that made the suggestion in an Aug. 18 letter to FDA and the Department of Health and Human Services.

FDA’s Division of Dietary Supplement Programs is part of the Office of Nutrition, Labeling and Dietary Supplements in the Center for Food Safety and Applied Nutrition. The Consumer Healthcare Products Association, Natural Products Association and United Natural Products Alliance also signed the letter recommending an upgrade for DDSP (Also see "Trade Groups Suggest Office Upgrade For FDA Supplement Division" - Pink Sheet, 7 Sep, 2015.).

“We are very hopeful that that notice will be transmitted to congress very soon. We think this move to make the DDSP an office is moving pretty quick within the agency because I think that’s something the agency and the industry agree is a good thing that needs to happen,” Mister added.

“I’m very hopeful that we’re going to see a notice to Congress very soon.”

Other sources with knowledge of FDA’s response to the suggestion said the agency has submitted a proposal to HHS, which determines whether organizational changes will be made by its agencies. After HHS or other federal departments approve restructuring by their agencies, they notify Congress of the proposals; while members’ approval is not required, they have 30 days to object.

“It’s important because it will allow this new office to compete with other offices within CFSAN for attention and resources. Rather than being buried down in ONLDS, dietary supplement programs would be an office that would … be on equal stature with those other offices in CFSAN,” Mister said.

“I think both the agency and the industry think that given the size of the industry and the need for strong enforcement, it ought to have that kind of attention and priority within the agency.”

Industry Still On The Hook

FDA and manufacturers and marketers, of course, will face the same problems that currently trouble the agency and the supplement industry if DDSP becomes an office.

And dietary supplement programs would not gain staffing by moving up FDA’s org chart. The programs’ staff, though, could place a higher priority on enforcement actions.

“Hopefully, that gives people in the agency incentive to pursue these things past the warning stage,” Mister said.

Still, he recommends stakeholders “be realistic and manage expectations” about DDSP becoming a CFSAN office.

“Divisions and offices have the same requirements in terms of full-time employees. It doesn’t mandate that there suddenly has to be this dramatic increase of resources, but it sure makes it a lot easier for the FDA to justify increasing the resources going to an office of dietary supplement programs,” Mister said.

However, an enforcement question currently before the agency and the industry – such as sales of bulk powdered caffeine to consumers – should not require more resources to resolve. FDA recently warned five firms that their bulk caffeine products are adulterated because serving sizes such as 200mg, equal to one-sixteenth of a teaspoon, indicated on the labels “cannot be accurately measured using common household measuring tools” (Also see "FDA Takes The Measure Of Bulk Caffeine In Warnings About Labels" - Pink Sheet, 7 Sep, 2015.).

Manufacturers and marketers should be responsible and cease selling bulk powdered caffeine to consumers, transactions that introduce “an unreasonable risk of injury or illness” because the products are easily and often unintentionally misused, Mister said.

“This is troubling to us because this seems to be an issue that should be easily solvable by the industry. The products ought to either be withdrawn and not available for consumer sale, or at the very least they should provide them in a way that has a pre-measured, single-serve dose for the consumer so that you don’t have this confusion.”

While other stakeholders have noted that FDA could be making an unreasonable argument that an average consumer does not have measuring devices needed for accurate dosing of pure powdered caffeine, Mister says the risk of harm from the products is clear.

A dose of caffeine-containing supplements such as sports nutrition products that exceeds the label directions might cause indigestion, but exceeding the labeled dosing for pure powdered caffeine can cause far more serious adverse events, including death.

“What the FDA is concerned about is that this product is being sold in bulk, in bags of powder, and even though they may have directions for use on the label, it really raises the question as to whether those are meaningful in a way that consumers can actually measure. If not they present an unreasonable risk of injury or illness under the conditions of use provided, which is the statutory standard for adulteration,” Mister said.

“We think it’s a pretty clear case that these are not able to be used by consumers in a way that’s safe when you’re presenting it as a bulk powder and expecting people to either have very teeny tiny measuring spoons or to have a milligram scale in their kitchen.”

CRN earlier in 2015 updated its member guidelines for caffeine-containing products with restraints against the sale and marketing to consumers of pure powdered caffeine. The group does not object to makers selling powdered caffeine to supplement manufacturers for use in their products.