“Probiotics that are not in the form of a pill, capsule, tablet or liquid and do not fit into the definition of a drug, device, or biologic should be considered a dietary supplement if they function essentially the same and do not come in the form of a pill, capsule, tablet or liquid,” the petition, drafted by Fox Rothschild on behalf of ProbioTech, said.
The document (docket no. FDA-2016-P-1133) was filed on April 7, and as suggested by wording in the text, was timed in anticipation to ProbioTech’s plan to market a probiotic delivered by a rectal suppository. “[It] should not be deemed as a new drug as there is no claim to diagnose, cure, mitigate, treat, or prevent a disease,” the document said. “The product should not be put through the onerous submission and approval process for a new drug substance.”
Who’s definition?
According to the document, the action requested is to “replace the language in the definition for a dietary supplement.”
But FDA law expert Ricardo Carvajal brought up a point in his blog post: “It’s not clear which definition of ‘dietary supplement’ the petition refers to, as the phrase ‘is intended to be taken by mouth as a pill, capsule, tablet or liquid’ does not appear in the FDC Act’s definition of ‘dietary supplement’ or in associated regulations (in relevant part, the statute defines ‘dietary supplement’ as an article ‘intended for ingestion’ in a variety of forms).”
Though the document does not specify under what authority the FDA could allow a suppository to be included as a dietary supplement, Caravajal argued that the “FDA has consistently taken the position that articles not intended for ingestion do not qualify as dietary supplements.”
What others in the industry say
Commenting on the petition, Loren Israelsen of the United Natural Products Alliance (UNPA) told NutraIngredients-USA: "Since the passage of the Dietary Supplement Health and Education Act in 1994, there has been continued interest in the development of non-swallowable delivery systems for dietary supplements. It was a topic that was thoroughly debated during Congressional negotiations prior to the passage of the act and was considered a deal breaker in the minds of a number of key players in Congress at the time. It would have been nice to have a lot of nutrient delivery options, but it wasn’t a possibility back then.
"This was well before transdermal patches and other new-generation delivery systems and a less sophisticated understanding of how nutrients can be administered and absorbed. But in the minds of both Congress and FDA, since dietary ingredients and dietary supplements were food based, one had to eat them—like you do foods—with the nutrients being absorbed in the GI tract.
"FDA’s view back then—and likely its view today—was very clear: the use of a dietary ingredient in some other delivery system and method of absorption is a drug delivery system.
"Since that time, a number of court cases have reaffirmed this reading of DSHEA, including ones for vitamin B12 nasal drops, drops administered in the ear, and patches on skin. In every case, the judges decided that if the product was not swallowed it was not a dietary supplement.
“Thus, in our view, this product would not likely pass muster with FDA to be recognized as a dietary supplement.”
Science always excites, but request is "short-sighted"
Speaking on behalf of the Council of Responsible Nutrition (CRN), Senior Vice President of Scientific and Regulatory Affairs Duffy McKay agreed with Caravajal. "Asking the FDA to change the definition is probably not effective because they have no authority," he told NutraIngredients-USA. "And assuming this is one reason to [amend] DSHAE is probably a little shortsighted as there has to be a larger conversation."
But McKay didn't want to discount the fact that it's normal for science and innovation to develop faster than regulatory bodies are prepared for. "[We] fully recognize the exciting science behind using probiotics topically, or in suppositories, or orally," he added.
More ease in manufacturing probiotic supplements in forms other than for ingestion may benefit the industry, he argued, because it will allow "the probiotic experts who know the right species and make sure they stay alive and package in the right packaging--one benefit if they are seen as a supplement is that the same suppliers, the experts, can continue handling them."
But a risk is that the floodgates may open up if done without careful planning. "It can open up the category too much to include other products we do not intend," he added.