Supplement Perspectives

Long-term Brand Building with Regulatory Help (Part 2 of 2)

Pharmachem’s senior director of new product development, Mitch Skop, concludes his seven-step plan.

Last week I offered four suggestions to get claims approval for your ingredients, which a key part of brand building. Here are the final three suggestions. Click here for part 1. 

5. Get professional help

It was crucial for us to get help in the U.S. with a law firm that was familiar with the FDA review process. From start to finish, it took over two years to present the proper materials and study data to obtain two structure function claims. It would have been nearly impossible for us to navigate the approval process without our law firm’s guidance.

In Canada, we utilized a firm specializing in helping companies gain regulatory approval for natural products. Canada differs from the U.S. in that companies seeking to launch a natural product must register it, and get it approved prior to selling it. In the U.S., you can sell a dietary supplement without registration, but are subject to FDA’s costly enforcement if you make unsubstantiated or misleading claims.

The process in Canada took over a decade, but was ultimately successful because of the vast dossier we had assembled, and continued to add to over the years. As a result of this master file built by our consultant, every Canadian company that wanted to launch a Phase 2 product had to reference the dossier created based on Pharmachem’s studies. Ultimately the NNHPD developed a monograph based almost entirely on Pharmachem’s studies.

The monograph originally made very conservative claims, but our consultant worked with the NNHPD to interpret some of our key studies and secure a more definitive weight management claim, as well as a glucose metabolism claim. Again, the role played by our consultant was crucial in gaining the license for these claims.

6. Differentiate yourself

The “me too” approach is by far the easiest route to take, but doesn’t really buy you much. After all, why should the consumer buy your product with the same ingredient and same claims? If you want to set yourself apart, you need to have a proprietary ingredient with studies showing safety and efficacy worthy of receiving unique claims. Otherwise you get lost in the vast sea of products.

7. Be persistent

As I mentioned it took a decade to get the Canadian license, but it paid off with approved claims. Continue to build your master file with new information and better designed studies. Pharmachem works in this way in countries around the world to have properly licensed and registered products.

With approved claims you have something to market. You can build a brand for the long term, and not be just another flash in the pan. We see our efforts to secure regulatory approval as another way to add value to our ingredients. Having substantive claims means something to the consumer. And that’s something we can all take to the bank. 

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