Drugs

Supplement Market ‘Not Perfectly Regulated’: Tave

FDA Office of Dietary Supplement Programs director Steven Tave told the 2020 Dietary Supplement Regulatory Summit 9/16 that while it is not correct to say that the dietary supplements industry is not regulated, “we can comfortably say at a minimum that the dietary supplement market isn’t perfectly regulated.” Tave addressed the “regulatory gap” that he said exists between what the law requires and what can realistically be reached through enforcement, according to an online post at Nutra Ingredients-USA.com.

“We can’t responsibly ignore the regulatory gap or pretend it isn’t there,” Tave said. “That’s not in anyone’s interest — consumers, responsible industry, or regulators. All of us who expect or demand a better-regulated dietary supplement market share a duty to identify and pursue ways to narrow the regulatory gap.”

Looking at current good manufacturing practices for supplements, Tave said that FDA inspects about 500 dietary supplement facilities a year, which represents fewer than 5% of all registered facilities. “To be clear, many firms take these requirements seriously and follow them faithfully,” he said. He also noted, however, that many of the FDA inspections are for follow-up and so the actual number of facilities inspected is even lower.

“This is because the rate of non-compliance when we do inspect is very high, probably the highest it is for any FDA-regulated commodity,” he said, “with frequent deficiencies in fundamental requirements like establishing specifications and testing to make sure that ingredients and products meet those specifications.”

Industry speakers at the virtual conference noted a resource scarcity for FDA and expressed frustration with a lack of agency action. It also was said that too many supplement companies are continuing to skirt the law and take advantage of the agency’s lack of enforcement.

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome