The report, titled Regulation of Dietary Supplements: Background and Issues for Congress, was issued by the Congressional Research Service yesterday. The report, written by health policy analyst Agata Bodie, is an update of an earlier report written former CRS analyst Amalia Corby-Edwards.
The report lays out for members of Congress and committee staffs how supplements are regulated and some of the issues surrounding the industry. The report covered how claims are regulated, FDA’s enforcement of GMP provisions and serious adverse event reporting.
Mention of current issues
The report also covered some issues of current concern. Those included FDA’s use of use of the drug exclusionary clause to find that CBD is not a legal dietary ingredient. Another current issue mentioned in the report is the desire by FDA to have a mandatory product listing. In addition, the report touches on the use of GRAS status as a workaround for a New Dietary Ingredient Notification, which some observers have characterized as a loophole in the regulations.
Why this update was issued at this particular time is still to be determined, said Daniel Fabricant, PhD, president and CEO of the Natural Products Association.
“These reports are usually issued at the discretion of a committee or a particular member of Congress. We are trying to figure out why this happened now,” Fabricant told NutraIngredients-USA.
Fabricant said in NPA’s view much of what’s in the report appeared to have come direct from FDA itself. For instance, the portion on the about the limitations fo current legislation, the report says,“Among these limitations is that under the current statutory framework, while entities that manufacture, process, pack, or hold supplements must register with FDA, the agency is not authorized to require listing of individual dietary supplement products. As a result, the agency is not aware of all the products currently on the market. “
“They try to make it look fair and balanced. But FDA has been on this jihad to get mandatory product listing for more than three years now,” Fabricant said.
Focus on CBD
Fabricant also noted that the language of the report closely mirrors FDA’s statements on the CBD issue, including raising the specter of creating an unwanted precedent if an exception to the drug exclusionary clause were to be carved out for the substance.
“FDA may issue a regulation creating an exception for CBD, but the agency has never issued such a regulation for any substance,” the report stated.
“In general, there is a lack of peer-reviewed research on the effectiveness of many other supplements. For example, in recent years, CBD has been promoted as a treatment for a range of conditions, including post-traumatic stress disorder, anxiety, inflammation, and sleeplessness. However, limited scientific evidence is available to substantiate or disprove the effectiveness of CBD in treating these,” the report continued.
Fabricant noted that while the report touched on the mandatory product listing idea and spent a lot of time talking about CBD, it had little to say about GMP compliance.
“There is not much in there about GMPs and at the same time this is the most active regulatory control they have,” he said.
Loren Israelsen, president of the United Natural Products Alliance, said the report will be helpful as Congress wrestles with dietary supplement industry issues in the session to come.
"This most recent update is a competent overview of the regulation of dietary supplements including current hot topics such as CBD, mandatory product listing and the drug exclusion provision of DSHEA. The timing of this report is interesting, just at the moment FDA, Congress and the DS industry are actively discussing the hot topics noted above," Israelsen said.
"CRS strives to be politically neutral and this report would seem to follow that goal. It's real value is as a useful refresher of the history and current issues concerning the regulation of dietary supplements. A topic that will keep CRS busy for years to come," he added."Given how heavily Congress, and staff particularly, rely on CRS for trusted information on the many complicated topics they have to deal with, this updated report is a positive development for those who care about dietary supplements," Israelsen concluded.