One example is medical food company VAYA Pharma, a subsidiary of Enzymotec (which was acquired by Frutarom last year, in turn acquired by IFF in May this year), which launched Vayarin PLUS last month, designed for adults with ADHD.
This newer launch is an extra strength version of Vayarin, which was originally formulated for children with ADHD between the ages of 6 and 13, Michelle Cuccia, CEO of the Maryland-based VAYA Pharma told us.
More specifically, Vayarin Plus is for “adolescents and adults over the age of 14 and weighing more than 97 pounds.”
The active ingredient in both Vayarin and Vayarin Plus is Lipirinen, a proprietary composition containing phosphatidylserine (PS) and omega-3 fatty acids enriched with EPA, she added. The original version has a daily dose of 150 mg of the mixture, while the adult version has 450 mg.
Phosphatidylserine, a phospholipid and component of the cell membrane received a qualified health claim for cognitive health from the FDA in 2003.
Medical foods a ‘complicated and amorphous category of products’
The medical foods category is not an easy one to play in. Vaya Pharma products have come into the regulatory cross hairs of the FDA several times, as we reported last year. The company was hit with an FDA import alert on three products in its current portfolio (Vayarol, Vayarin and Vayacog), apparently due to a disagreement about the products’ positioning as medical foods.
In addition, an Enzymotec distribution partner, Rainbow Gold LLC, received a warning letter on Vayarin, based on what the agency said were impermissible drug claims.
Steve Mister, president of dietary supplement trade group Council for Responsible Nutrition, expressed last year that the organization will turn its attention to medical foods because “these products offer the potential to help many consumers manage disease with nutritional support.”
But he admitted that the category is “a complicated and amorphous category of products.”
“There are many views on how they fit into the regulatory framework, whether they should require closer doctor supervision, and whether insurance companies should pay for these nutrition therapies. One of my concerns at this point is whether there is sufficient common ground among the industry participants to come together in pursuit of some common policy goals.”
The dietary supplement industry has morphed into something much bigger, industry expert argues
“We are no longer the dietary supplement industry,” said Scott Bass, partner and head of global life sciences at Sidley Austin LLP, during his opening remarks as co-chair of ACI’s Sixth Annual Legal, Regulatory and Compliance Forum on Dietary Supplements in New York last month.
"When we sat down in 1992 to 1994 drafting this law, we were called the ‘health food industry,’” he said. “The advent of DSHEA is when we created the new category ‘dietary supplements,’ so we became ‘the dietary supplements industry.’”
Today, the industry has morphed yet again, according to Bass, into one that also includes medical foods and foods for special dietary use, all part of a burgeoning functional food, over-the-counter (OTC) market. READ MORE