Supplements - Case Studies
Marketing Dietary Supplements in the U.S.
Fast Growing Dietary Supplements Company
Assist client in their development and marketing of a new line of dietary supplement products in the United States. Ensure compliance with FDA and FTC regulations and guidelines:
The client has a few dietary supplements that they were planning to market and wanted to verify that they complied with FDA regulations. The first course of action was to review the ingredients, to make sure none of them were considered new dietary ingredients, that would require a New Dietary Ingredient Notification (NDIN) to FDA.
After this process, we reviewed the product labels for compliance with current regulations. There were many changes made throughout this process as FDA in very specific on what content can appear on a label and where on the label it appears.
During this process, we verified that all claims on the labeling were truly structure/function claims and not claims that are related to disease. After this review, RJR assisted the client in filing the necessary notifications with the FDA regarding labeling claims.
The last step i this process was to review any advertising material against both FDA and FTC guidance. the client's marketing campaign included web site content, print ads, television commercials, and social media, such as Twitter and Facebook, to promote their products. All of these needed to be reviewed to verify that marketing claims were not too aggressive and that all claims related to an effect on the structure and function of the body, rather than an effect on disease.
The client's products were successfully marketed, their product line continues to grow and they continue to leverage RJR Consulting for their regulatory needs.
Registration of Supplement in Peru
A U.S. manufacturer was interested in receiving approval to market their product in Peru. the client was preciously marketing their product in the U.S. and other select countries, where only a "Notification" and not a formal "Registration" of the product was required.
The initial work involved first understanding if the product would be classified as a health supplement in Peru. Once that was confirmed, then the regulatory requirements and documentation that was required to submit to DIGIMED (Peruvian Healthcare Authority) was researched and provided to the client.
RJR then completed a Gap Analysis on the information provided, to ensure that the appropriate information could be provided, which increased the odds of regulatory approval and product licensing. Adjusting product claims, the label and packaging are usual finishing touches that are requested by most Agencies, in order to comply with their product classifications and regulations as written. RJR's local affiliate in Peru became the Authorized Representative on the submission and designated license holder, as the legal entity in Peru.
The submission was submitted and approved by DIGIMED. Post marketing responsibilities, such as filing future technical and administrative variations on the license as submitted and the affiliate being able to file vigilance safety reporting on the product were explained to the client. The product license was issued for five years, at which time a renewal application will be applied for, six months in advance of the expiration date. This closure allowed the client to locate a distributor and shortly afterwards, to begin shipment and marketing in Peru.