FDA official highlights noncompliance with dietary ingredient requirement, enforcement challenges

Only a small fraction of the ingredient notifications required under the Dietary Supplement Health and Education Act of 1994 (DSHEA) have been submitted to FDA since the 1990s, an agency official concluded during a May 16 public meeting.

Distributors and manufacturers must notify FDA, providing the agency evidence of safety 75 days before introducing a new dietary ingredient (NDI) into interstate commerce.

Although many companies are suspected of neglecting to comply with the notification requirement, the director of FDA’s Office of Dietary Supplement Programs (ODSP), Steven Tave, suggested his agency doesn’t have a way to accurately measure all the NDIs that should have been submitted to FDA but were not.

Part of FDA’s challenge is the law exempted from the NDI notification (NDIN) requirement dietary ingredients marketed before Oct. 15, 1994, and those that have “been present in the food supply as an article used for food in a form in which the food has not been chemically altered.”

Nonetheless, Tave calculated less than 25 percent of the required NDINs have been submitted to FDA. His conclusion is based, in part, on an estimated 50,000 dietary products on the market today. Tave’s figure is at the low end of FDA’s estimates of the current dietary supplement products on the market, which could number as high as 80,000.

Only 4,000 products were on the market in 1994, according to Congress’ estimates, so at least 46,000 new dietary supplement products have been introduced since 1994.

Responding to criticism that companies have failed to comply with the NDIN requirement, industry sources have pointed out many new products are exempt from the NDIN requirement because they are, for example, combinations of old ingredients grandfathered under DSHEA.

Tave acknowledged such exemptions were not subject to the NDIN requirement.

“Let’s say 90 percent of these products did not require a notification," he said. “That still leaves 10 percent of the products that did require a notification.”

That means the distributors or manufacturers of 4,600 products were obligated to notify FDA, providing evidence that their NDI is reasonably expected to be safe. However, only about 1,100 NDINs have been submitted to FDA since the law was signed, Tave reported.

Tave noted people could “quibble with the math,” but he suggested the order of magnitude was correct.

“The point is that compliance clearly needs to improve,” he said.

Challenges targeting copycat ingredients

As the public health agency responsible for enforcing DSHEA, FDA is a frequent target of criticism. The agency should be enforcing the NDIN requirement more vigorously and often, according to consumer advocacy groups and dietary supplement executives.

Among those who have criticized FDA for failing to enforce the law: companies that have invested potentially hundreds of thousands of dollars in an NDIN. They have expressed repeated concerns over “copycat” ingredients that have not notified FDA.

“Effective enforcement by itself provides something of a marketing advantage for products that have successfully gone through the notification process,” Tave said.  “At the same time, commercial incentives really won’t be worth anything if there isn’t effective enforcement to prevent noncompliant copycat products from free rides.”

He articulated challenges that his agency faces taking enforcement actions against copycat ingredients. For example, a competitor’s dietary ingredient might be GRAS (generally recognized as safe) and lawfully on the market through the ‘food supply’ exception to the NDIN requirement.

But FDA wouldn’t necessary realize that until the agency has “traveled well down the path of an enforcement action” since FDA has the burden under the law to demonstrate a dietary ingredient is adulterated, Tave said.

Tave also suggested a case against a competitor to a product that has successfully gone through the NDIN process is “far from a slam dunk,” even if the competitor can’t rely on the above exception to the notification requirement.

“Recall that we’re typically being asked to bring an enforcement action to protect a product or an ingredient that has successfully gone through the notification process,” he said. “That means that when we reviewed their data, we had no objections to the notifier’s conclusion that the product is reasonably expected to be safe. It follows that a knockoff product that is identical or very similar to that product is probably—at the very least—not clearly unsafe.”

Even if FDA can establish “a product is technically adulterated under DSHEA, there’s still a practical question of resources,” Tave explained. “And to make the best use of our finite resources, we’ve established three strategic priorities … consumer safety, product integrity and informed decision making.”

Assuming FDA sends a warning letter to a company because it’s consistent with one of its priorities, Tave said “it’s important for us to be able to follow them up with judicial action if we don’t achieve compliance.” But FDA relies on the U.S. Department of Justice (DOJ) to bring an enforcement action in federal court, and Tave said DOJ also has “limited resources and competing priorities.”

“Will DOJ be willing to take on a case that faces all of the obstacles I just mentioned?” he asked.

He also cited a legal argument that a distributor can freely market an ingredient without notifying FDA if another company previously submitted a NDIN for the same ingredient.

“I’m not saying that I agree with this position, but it’s one that we have to acknowledge and recognize, and it’s one that we have to respect as least as a potential defense that we’d encounter in any enforcement action,” he said.