Are supplements with transmucosal delivery systems crossing the drug barrier?

Kimberly Lord StewartOver recent years, sublingual drug strips that dissolve between the cheek and gum have been tested for use in dentistry and as a noninvasive way to administer insulin. Even the manufacturers of Viagra are toying with the idea of a quickly dissolving tablet for a quicker—no wait—response.

It is well proven that sublingual delivery systems deliver a faster response. For insulin the benefits are clear—less risk of diabetic shock. For Viagra, a quicker response may or may not be a good thing (couldn't resist)… but what about say dehydration, or trouble falling asleep, where an immediate response is also beneficial?

This was the question posed by dietary supplement industry members on blogs and social networking sites recently. Is the same sublingual strip delivery system for drugs acceptable for dietary supplements?

A host of websites for Internet and multi-level marketing supplement companies tout the benefits of sublingual strips to improve absorption of various nutrients and dietary supplements including melatonin, electrolytes and antioxidants. Even larger than life Shaquille O'Neal's endorsement of Enlyten branded sublingual strips was plastered across the equally large video banner in New York's Times Square.

The basketball All Star may know his game but he doesn't know much about the Dietary Supplement Health and Education Act (Enlyten's parent company, Health Sport, did not return our request for an interview). O'Neil may be new to DSHEA, but even contract manufacturers of the strip technology are marketing the strips as an effective means to enhance the bioavailability of herbal products.

No doubt, sublingual methods for drug delivery are well proven to improve bioavailability for drugs. Drug is the key word here. FDA has no problem with sublingual delivery systems for drugs or even mouthwash strips, though dietary supplements are another matter altogether.

According to FDA, only products intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter the body directly through the skin or mucosal tissues, such as transdermal or sublingual strips, are not dietary supplements.

"Under the law, a dietary supplement must be intended for ingestion. A product that is delivered transmucousally or transdermally cannot be sold as a dietary supplement," said Ivan Wasserman, principle at Manatt, Phelps & Phillips, LLP.

If sublingual Viagra or a Listerine mouthwash strip is alright by FDA, then why not a dietary supplement strip? In this case, the rule is fairly clear, says Andrew Shao, vice president for regulatory affairs for the Council for Responsible Nutrition. "The issue is not with the product composition, whether its antioxidants or melatonin, FDA objects with the intended delivery system, in this case sublingual," he says.

"Clearly, companies are interested in finding novel and performance-based delivery systems, and we have seen nasal sprays, sublinguals, ear drops, skin patches, eye drops — you name it, but I am convinced that FDA will absolutely hold the line that because supplements are foods, they are necessarily consumed in historic and traditional ways involving gulps and swallows," says Loren Israelsen, Executive Director, United Natural Products Alliance.

Drug, supplement or both? This is not a new question. In past years, other companies have tried to market sublingual vitamin B products to no avail. FDA has been consistent in its messaging through a myriad of warning letters.

To the consumer the line between drug and supplement blurs further when sublinguals are marketed with a drug delivery system and a supplement's fact label. Now consider a beverage with an efficacious dose of vitamins… is a swish in the mouth considered mucosal or sublingual delivery? Only FDA can say, or can they?

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