In the fast-paced world of dietary supplements, marketers play a critical role in communicating the benefits and value of products to consumers. However, marketers may not always be well-versed in FDA compliance, leading to potential regulatory pitfalls. This case study of our recent engagement with a client underscores the importance of expert review in maintaining label compliance.
The Marketing Misstep
Our client, a relatively new entrant in the market, had engaged a Contract Manufacturing Organization (CMO) to produce dozens of products in their line. The CMO also provided content intended for creating “FDA-compliant labels”. However, after discovering issues in their labels, the client wisely decided to have them reviewed by experts well-versed in FDA regulations.
The Compliance Compass
We were entrusted with reviewing a large batch of the client’s labels and found significant errors across the board – from ingredient naming to formatting. Such errors could have serious regulatory implications. Naturally, the extent of the suggested revisions initially startled the client. They needed to decide whether to trust our review or the CMO’s version of the labels.
To ease their concerns, we provided detailed references to the FDA regulations and shared excerpts from Warning Letters related to similar errors. This transparency validated our recommendations and helped educate the client on the nuances of label compliance.
The Path Forward
Though disheartened by the sheer number of non-compliant labels, the client appreciated our ability to identify and rectify the errors. They decided to engage us to review all future labels produced by their CMO, ensuring compliance would be at the forefront of their labeling process moving forward.
Marketing Meets Compliance
This case study highlights an important reality in the dietary supplement industry: marketing and compliance must go hand-in-hand. While engaging marketers and CMOs can be a vital part of your product development and launch, it is equally important to have regulatory experts review their outputs.
At The Supplement Consultants, we bring an in-depth understanding of FDA regulations to the table, helping you navigate the complex terrain of label compliance. By getting us on board, you can ensure that your labels are compelling and fully compliant. Reach out to us today to keep your products on the right side of the law.