Supplement Perspectives

A Friendly Legal Reminder

Your formulation may contain ingredients helpful against allergies, but you can't say anything about that.

One thing blogs should do is promote discussion, so I was thrilled to see attorney Steven Shaprio of Ullman, Shapiro & Ullman comment on Mark Becker's post, "Yes! There are Natural Options for Allergies."

What Shapiro wrote wasn't exactly encouraging, but it's a powerful reminder from one of the industry's foremost attorneys. Here it is:

While I have no reason to disagree with the correctness of the science, FDA has consistently taken the position that any dietary supplement claiming to be beneficial for the treatment, cure or prevention of allergies, any allergies, which FDA considers a disease, is an unapproved new drug as demonstrated by several dozen Warning Letters and Courtesy Letters.

That is a signifcant obstacle, which makes it very hard from a marketing standpoint. Also, it shows the importance of making sure your marketing is vetted, so you don't have to deal with the federal government and the costs of a rebrand. This leads to another question: How in the world do you advertise a product that does have ingredients with legitimate research in the fight against allergies? Is it even possible?

My feeling is that it's not. I offered Shapiro the chance to write something for the blog, and he responded thusly: "I would like to but I am not sure what else there is to say. FDA objects to all allergy claims and has consistently for a long time -- http://www.fda.gov/ohrms/dockets/dailys/04/apr04/040604/97s-0163-let00737-vol22.pdf."

If you'd like to add something to the discussion, please do. And if Shapiro decides to write something--and I hope he does--I'll be sure to post it.

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