Foods and supplements aimed at autism must walk fine regulatory line, attorney says

One recent multivitamin launch from a company called Spectrum Nutraceutical​ included a specific mention of methyl B-12, a form of the vitamin that is said to more effectively address the reported difficulty autistic children have in absorbing that ingredient. The marketers of the product claim that it provides “all the nutrients that a child with autism needs in order to live life fully, almost like other kids. The supplement provides them the fighting chance to live normally despite their condition.”​

Another launch, this one a food, was born of the experience of a Michigan woman named Heidi Scheer who is the parent of an autistic child. She has launched a product called the Team TMR Chocolate Trail Mix Protein bar, that is said to be a non-GMO, organic, allergy-friendly energy bar​ made with chocolate chips, protein and other healthy ingredients and designed for children with food allergies or special diets.  Scheer claims to have “recovered her son from autism using intensive therapies, with special attention to nutrition and special diet.”​

Anecdotal evidence​

Anecdotal evidence seems to lend credence to the idea that diet and psychological and neurological symptoms are closely linked in autistic children. Other reports include links of digestive anomalies like leaky gut syndrome with the condition (sensitivity to gluten is often mentioned, too). Parents share experiences and infomation on sites like autismspeaks.org​, which is were some marketers seem to have gleaned ideas for what to say about their products. 

Leaving aside whether these products actually work, or whether they target legitimate pathways that influence the manifestation of the condition (anecdotal reports and tabloid news stories abound, but hard data is currently lacking), the question becomes, can you actually market such a product legally in the United States?

“Of course any food or supplement product is governed by the general principle that you cannot sell such a product to treat, cure or prevent a disease,”​ Justin Prochnow, a principle in the firm Greenberg Traurig told NutraIngredients-USA.  Prochnow said the question is a topical one, as his firm has fielded a number of recent inquiries from potential clients about the marketing of products targeting autism.

“Any mention of a disease in the name or marketing of a product is not necessarily a red flag, but it is certainly a yellow flag,” ​he said. “Can you sell a supplement or a food targeted to a specific disease or condition without claiming to treat the disease?  In general you have to go back to the mantra (mentioned above).”​

Walking the line​

Prochnow said the releases mentioned above at at first glance appear to walk the fine line of communicating with a customer about a disease or condition of concern without claiming to solve it for them.

“If I play devil’s advocate here, they are not claiming to treat the disease. They are not claiming to prevent it. But it is certainly not a black-and-white issue. It is a gray area. A regulator might see it differently,”​ Prochnow said. 

And as far as referencing the kinds of commucations that can be found on the autism sites, Prochonow said companies are well advised to restrict themselves to precedents that have been established in previous warning letters to companies that associate their products or ingredients with specific studies on disease populations. Making that direct link has been interpreted as making an implicit disease claim, Prochnow said.

“The general principle is that you can direct customers to a site, but not to a specifc study (or, in the case of the sharing sites, a specific post).  I can include a general link to PubMed, for example. I look at it this way: I can show people the way to the book store, but I can’t direct them to a specific book,”​ he said.