In a warning letter to Focus Laboratories, Inc. the agency took the North Little Rock, AR-based company to task over the marketing of its Tozal Complete Eye Health Formula product. Focus Labs provides a variety of eye health products including materials for opthamologists. The Tozal product’s formula is packaged as sofgels that contain taurine, omega-3s, vitamins A, C, D3 and E, zinc, lutein and zeaxanthin. Focus says the product is intended “for the distinct nutritional requirements of individuals diagnosed with, or at risk for, Age Related Macular Degeneration.”
That claim and a number of others were cited by FDA in the warning letter. Among the other claims cited were “[M]ay lower the risk of developing AMD” and “[R]educed the progression of advanced AMD by 25%, and the risk of moderate vision loss by 19%.” Such claims made the product an unapproved drug, the agency said.
In addition, the product can’t be classified as a medical food, FDA said. One of the primary caveats of a medical food classification is that the condition in question must include a dietary deficiency component. In other words, the disease causes a problem in digesting certain nutrients, shortfalls that can be met with a product specifically formulated to address that need. Macular degeneration as a condition doesn’t fit that bill, the agency said.
“Because FDA is not aware of any distinctive nutritional requirements or unique nutrient needs for individuals with age related macular degeneration, your Tozal product does not meet the regulatory criterion for medical foods,” the agency said.
“FDA takes a very restrictive view of medical foods and it’s not an end-around from the prohibition for foods and dietary supplements against making claims that they treat disease,” attorney Ivan Wasserman told NutraIngredients-USA. Wasserman is a managing partner in the firm Manatt, Phelps & Philips.
“I think both medical foods as well as homeopathics have been seen as a way for OTC products to make disease claims but we have seen FDA cracking down on both categories and taking a very narrow view of what is approved,” he said.
Inborn errors of metabolism
The medical food category was put in place originally to help in the development of products to deal with a very narrow band of conditions called inborn errors of metabolism. In one of these, phenylketonuria, children produce insufficient amounts of the enzyme phenylalanine hydroxylase (or have none at all) and thus lack the ability to convert the amino acid phenylalanine to tyrosine. Medical foods formulated with very carefully controlled amounts of phenylalanine can prevent toxic amounts of this amino acid from building up in the blood. It is this type of very specific nutritional situation that can be addressed by a medical food, the agency has said. Even diseases with a broadly acknowledged nutritional component, such as diabetes, are not necessarily candidates for medical food status, the agency has said. The agency has recently posted an updated Q&A on medical foods.
“I don’t think this is anything different that what they’ve said before. They are just enforcing it more,” said attorney Justin Prochnow, a shareholder in the firm Greenberg Traurig.
“Most of the time you see companies calling their product a medical food because they want to be able to say they are treating a disease. Typically a medical food is a tricky proposition because it has to be for a condition that can’t simply be treated by a change in the diet,” he said.