The initiative comes as part of efforts to increase transparency within the sector. But given that the list is not intended to be exhaustive, just how useful is it for consumers or industry?
A ‘one-stop shop’ of ingredient information
The FDA’s Dietary Supplement Ingredient Directory is in list form and includes links to the agency’s actions and communications for each ingredient listed, with links to separate FDA webpages where applicable.
“The directory is intended to be a one-stop shop of ingredient information that was previously found on different FDA webpages,” it states. “This directory is intended to help manufacturers, retailers, and consumers stay informed about ingredients that may be found in products marketed as dietary supplements and quickly locate information about such ingredients on the FDA’s website.”
Listings vary greatly in terms of quantity of content. For example, the entry for CBD lists two links under the “Agency Actions/Statements” tab. The first of these links to a webpage with extensive information relating to strategy and policy for the regulation of different cannabis products, dating back to 2017; the other lists various warning letters sent to companies accused of marketing unapproved new drugs that allegedly contain CBD, the first of which is dated 2015.
In contrast, the listing for biotin links to just one safety warning, made in 2017 and updated in 2019.
Directory ‘not intended to be a comprehensive list’
There are currently 27 entries in the directory.
However, the webpage adds: “It is important to note that the directory is not intended to be a comprehensive list of all ingredients used in products marketed as dietary supplements and may not include all actions the agency has taken with respect to a particular ingredient.
“For example, all actions may not be listed if the agency has taken many similar actions and some older actions may not be listed, especially if they do not reflect the agency’s current position. The FDA will update the directory periodically to reflect new developments.”
Unlike in the EU, where food supplements are regulated as foods and any new substances proposed for use as sources of nutrients in food supplements must undergo a safety assessment by the European Food Safety Authority (EFSA), it is not part of the FDA’s remit to approve supplements for safety before they are placed on the market. In fact, many dietary supplements can be marketed without notifying the FDA at all.
It leaves open the possibility that people may check the list and assume that the absence of any warning letters means an ingredient is safe.
Dietary supplements ‘should be required to list with the FDA’
It comes after the FDA’s Commissioner said he would support the introduction of a requirement for supplement manufacturers to list their products with the agency.
In an FDA Voices blog published in February, Robert Califf wrote: “I hope to see an improved framework to appropriately regulate dietary supplements during my tenure. This enormous industry continues to grow, and it’s now part of everyday life for many families.
“Dietary supplements should be required to list with the FDA and companies should be accountable for revealing what is in the supplement being sold. In the long run, we will have more information about the benefits and risks of dietary supplements as our methods of evidence generation improve, and I hope for a regulatory regime that can encourage better information for consumers to be informed about their choices.
“Although it will take some time to achieve the optimal regulatory framework, given the size and impact of the industry, we need to constantly update our internal approach and build awareness.”