FDA funding gap has reached crisis levels, says report

By Clarisse Douaud

- Last updated on GMT

Related tags: Dietary supplement industry, Food and drug administration, Dietary supplement

Safety issues concerning dietary supplements could reach a "crisis"
point if more money is not channeled into the US Food & Drug
Administration (FDA), according to a new report from the
Subcommittee on Science and Technology.

Released yesterday, the report of the Subcommittee on Science and Technology is a year-long review that has attributed the agency's shortfalls in supporting new technologies and ensuring food safety to a failure to increase resources and meet soaring demands.​Time and again, adequate funding for the federal authority has been targeted by the dietary supplement industry itself, which feels it must do its own policing work. The committee specifically highlights the often overlooked science behind nutrition, as well as the areas of cosmetic and dietary supplement safety. "In fact, these areas must be revitalized and prioritized independently of both food and drug issues to redress decades of neglect before a serious crisis emerges,"​ states the report. One cause of such a crisis, according to the subcommittee, is that FDA's scope has grown at the same time as industry has grown, yet this has not been accompanied by an equivalent growth in funding. ​The agency claims to regulate $1 trillion in consumer products, or 25 cents of every consumer dollar spend in the US. Over the past 35 years, according to the report, the decrease in FDA food inspection funding has forced the agency to reduce the frequency of such inspections by 78 percent. ​Under this umbrella, the dietary supplement industry has grown exponentially, creating further strain on the agency's fragile resources and spurring the subcommittee to dub these products as lacking in checks and balances. "The dietary supplement industry has grown to more than $20bn in annual sales, and millions of Americans use those products every day,"​ states the report. "But the legislation authorizing FDA regulation of those products has never been funded, the practical effect being that the products and their health claims go essentially unregulated." ​Such references to being unregulated are likely to make industry uneasy. This term is frequently bandied about in the media and used to describe the dietary supplement industry much to its dismay. While this market is not pre-market regulated like pharmaceuticals, the dietary supplement industry asserts that it is most certainly post-market regulated, and that new regulatory measures will further ensure this. These regulatory changes include new Adverse Events Reporting (AER) legislation and upcoming Good Manufacturing Practices (GMP) regulations. However, while legislation has caught up to the advances of industry, whether FDA can now keep up in enforcing these changes remains to be seen. According to the subcommittee, the federal agency is not able to fulfill its responsibilities, let alone maintain pace with advancements. "The FDA cannot adequately monitor development of food and medical products because it is unable to keep up with scientific advances,"​ states the subcommittee. The authors highlight nanotechnology as an example of an emerging field FDA simply does not have the resources to fully oversee. "The lack of new science capability/capacity places the FDA mission at risk for those many products at the leading edge of innovation,"​ says the report. "This compromises not only the public health mission since the Agency cannot effectively regulate products built on emerging science, but it also hamstrings the Agency's ability to support innovation in the industries and markets that it regulates." ​ Beyond increased funding, the report's recommendations include new structures within the agency to deal with scientific innovations specifically.

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