Called ‘Supplement your Knowledge,’ the resource is broken down into four sections, each presented as an infographic of sorts, in downloadable PDF form.
Regulation primer, advice on talking to doctors
The first section gives an overview of how dietary supplements are defined and how they are regulated by FDA. The Agency placed in boldfaced type the notice that, “FDA does not have the authority to approve dietary supplements or their labeling before they are sold to the public.” That notice also appears in boldface type (with slightly different wording) in the fourth section of the resource.
The second section gives a guide for consumers on how to best have a conversation with their healthcare providers on their supplement use. Most physicians are in the know enough these days to at least ask what supplements a patient is taking, but FDA recommended printing out the provided form to fill in to present to their doctors or pharmacists.
Adverse event reporting
The third section of the resource focuses on the adverse event reporting system, which, from a consumer perspective, may be the least well known and most misunderstood portions of federal dietary supplement regulation.
The section educates consumers on what constitutes an adverse reaction and how they can arise, such as “if you start taking a new product, take supplements in high doses, take multiple supplements, or take supplements instead of or in addition to medications.”
It also goes through all of the reactions that could constitute a reportable adverse event, such as “fatigue or appetite loss; severe, persistent nausea, vomiting, diarrhea, or abdominal pain;
severe joint or muscle pain; yellowing of the skin or eyes,” as well as other indications.
The section advises consumers to report adverse events directly to FDA (two points of contact are provided). However, it does not tell consumers to contact the manufacturer. Every supplement label by law is required to have a phone number expressly for the purpose of receiving such reports.
Rick Kingston, PharmD, vice president of scientific and regulatory affairs for SafetyCall International, thought the Agency may have dropped the ball on that one in not advising consumers to also contact the companies directly (Kingston is also a professor at the University of Minnesota School of Pharmacy). He pointed out that companies are required by law to collect all adverse event reports and to forward the serious ones on to FDA. Also, in the case of life threatening adverse events, the manufacturers are the ones who can do something about the problem quickly.
“It’s unfortunate that FDA continues to advise consumers to report any suspected adverse events involving supplements directly to FDA as opposed to also encouraging them to reach out to the manufacturer. Information sent directly to FDA takes the manufacturer out of the loop when it’s the manufacturer who is in the best position to investigate and take immediate action if it’s warranted,” Kingston told NutraIngredients-USA.
“In the end, when reports are only sent to FDA, the manufacturer receives the very limited information that is available on the FDA website and shared with the general public and that does not include reporter name and/or contact information. Lastly, FDA should advise consumers that manufactures are required to monitor adverse events and report all serious incidents to the FDA. This keeps everyone in the loop to ensure effective product safety,” he added.
In the fourth section, on how FDA monitors safety, the Agency lays out how federal law precludes it from approving supplements before they go to market. “In fact, they often can introduce dietary supplements to the market without even notifying FDA,” the document says. This would apply to supplements on which no claims are made, which is a level of detail the document doesn’t go into. If a supplement manufacturer intends to make a claim on a product that claim is supposed to be submitted to FDA prior to going to market. While the document says ‘often,’ the large majority of supplements make some form of structure/function claim, and so would be subject to this requirement.
The safety section also notes that the burden of safe manufacturing falls primarily on companies, with FDA provided a backstop in the form of period inspections and working with companies on recalls when necessary.
You can access the full resource here.