The agency yesterday briefed Congress on the findings of a report it had been asked to conduct on FDA’s oversight and regulation of dietary supplements.
Published at the end of January, GAO’s report identified areas where the agency is still lacking, and recommended a number of changes that would be necessary to ensure a safe supplements market. These include requiring supplements manufacturers to submit lists of all products they sell and to report all adverse events related to supplements – not just serious adverse events.
To access the full report, click here.
Purpose
GAO’s investigation came against a backdrop of concerns raised by previous reports on supplement safety and FDA’s regulation of the products. However, FDA has since published draft guidance on requirements for reporting adverse events, and also implemented new Good Manufacturing Practices (GMPs) regulations for supplements.
For the current report, GAO was asked to examine:
· FDA’s actions to respond to the new serious adverse event reporting requirements
· FDA’s ability to identify and act on concerns about the safety of supplements
· FDA’s ability to identify and act on concerns about the safety of foods with added dietary ingredients
· FDA’s actions to ensure that consumers have useful information about the safety and efficacy of supplements
Findings
GAO concluded that FDA has taken “some steps” to identify and act upon safety concerns related to dietary supplements. However, it found that a number of factors still limit the agency's ability to detect concerns and remove products from the market.
Concerns raised by the report include:
· FDA has limited information on the number and location of dietary supplement firms, the types of products currently available in the marketplace, and information about moderate and mild adverse events reported to industry.
· FDA dedicates relatively few resources to oversight activities, such as providing guidance to industry regarding notification requirements for products containing new dietary ingredients.
· Once FDA has identified a safety concern, the agency's ability to remove a product from the market is hindered by a lack of mandatory recall authority and the difficult process of demonstrating significant or unreasonable risk for specific ingredients.
· Consumers remain undereducated about dietary supplements, and uninformed use of the products may expose them to greater health risks.
· The boundary between dietary supplements and conventional foods containing dietary ingredients is not always clear, and some food products could be marketed as dietary supplements to circumvent the safety standard required for food additives.
Recommendations
The report sets out the following recommendations:
· FDA should require dietary supplement companies to: Identify themselves as a dietary supplement company as part of the existing registration requirements and update this information annually; provide a list of all dietary supplement products they sell and a copy of the labels and update this information annually; and report all adverse events related to dietary supplements.
· FDA should issue guidance to clarify when an ingredient is considered a new dietary ingredient, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing ingredient identity.
· FDA should provide guidance to industry to clarify when products should be marketed as either dietary supplements or conventional foods formulated with added dietary ingredients.
· FDA should coordinate with stakeholder groups involved in consumer outreach to: Identify additional mechanisms for educating consumers about the safety, efficacy, and labeling of dietary supplements; implement these mechanisms; and assess their effectiveness.
Tomorrow, NutraIngredients-USA.com will examine industry and consumer group reactions to the report.