Medical foods specialist branches off into dietary supplements
“This has been part of our long-term diversification strategy,” William Shell, MD, told NutraIngredients-USA.
“Not all of our products based on our base technology need to have physician supervision. The FDA recognizes that certain products do need physician supervision,” he said. “But there are certain symptom based, structure function-based claims that are amenable to self diagnosis and management. Simple headaches, for example, are usually treated by patients without the need for prescription medication. Nasal decongestants are usually used by the patients who self diagnose and self treat.”
Targeted Medical Pharma, based in Los Angeles, up to now has been focused exclusively on medical foods, all of which are based on amino acids in various combinations and are aimed at conditions such as hypertension and pain.
Division to launch with four products
The new supplement division, which has yet to be named, will feature four products to start, which are currently in the research and development phase. They include a nasal decongestant, sleep aid, an appetite suppressant, a formula for pain and a formula that supports healthy cognitive performance. The products utilize the company’s patented platform, which it calls “targeted cellular technology” that aims to increase the effectiveness of milligram amounts of neurotransmitter precursors. The liquid products feature a “swish and swallow” delivery mode that is designed to allow digestive enzymes in saliva to initiate and facilitate digestion.
The first product, scheduled to be launched in November, will be an oral dietary supplement featuring a proprietary sinus health blend designed to support healthy sinus and immune function, and help relieve nasal congestion, sinus pressure and runny nose associated with allergies and colds. Clinical trials on this product, branded as Clear Ways, are nearly complete, Shell said.
Keeping claims separate
Shell said splitting off certain products into the new division made sense from a messaging standpoint, especially when it comes to avoiding crosses regulatory boundaries.
“The structure function claims can’t be sued as a mimic for a disease claim,” he said. “A runny noise is a function claim. A treatment for allergic rhinitis is a disease claim. So therefore there is room for both sets of products, particularly if the industry respects the concept of claims and how they are made.”
Initial distribution of the products will be through the company’s existing physician network that includes about 1,000 locations, Shell said. The company will also offer the product online and in certain smaller pharmacies. Trial distribution of the nasal decongestant in doctors’ offices resulted in a 95% reorder rate, Shell said.
Medical foods guidance
The new division has been under development for a couple of years and was not a result of any irritation with the FDA’s recently released revised draft guidance on medical foods, Shell said.
“We think there are a lot of good things in that guidance and we support it. There are some technicalities on which we will be responding to FDA. We will be commenting but not aggressively commenting. In general we thing the medical food industry has been quite good at following the guidelines,” he said.