FSMA Compliance Lessons

For those still learning about FSMA, food labeling, nutrient content claims, and website marketing claims, reading this post and the entire warning letter is suggested. This letter is a lesson in what not to do when operating a conventional food company, but the supplement industry can also learn from the website disease claims and some of the FSMA requirements referenced here. Wow, this was a fun post to write, and I could have written a small novel with the learning opportunities. For now, here are the high points.

🔷First, let’s talk about the marketing claims (my favorite topic).

🔹 Product tags are mentioned in this warning letter. The company was using product tags to market the intended use of the product, such as “depression” and “anxiety.” I haven’t seen product tags cited in a warning letter for a while, but this is a good reminder that product tags are marketing. I write more about product tags and meta tags here. 

🔹 The product descriptions also include numerous disease claims such as “Helps Fight Infections Like Cold & Flu.” Even though the company was inspected in April 2023, FDA did not start reviewing its website until three months later. This trend reminds companies that have been inspected to review their online marketing. Removing these serious claims would have helped the company avoid this scathing warning letter. I write more about this here. 

🔷Several of the herbal products had a bizarre DSHEA-like disclaimer on the labels. The products were labeled with Nutrition Fact Panels but had the following warning. This is so weird I had to add it to this post.

👉From warning letter. “Statements regarding dietary supplement have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent and [sic] disease or health condition.”

👉FDA then adds these comments. “To the extent you intend these products to be conventional foods, you should not refer to them as dietary supplements. We note that, under section 201(ff)(2)(B) of the Act, a dietary supplement “means a product that . . . is not represented for use as a conventional food or as a sole item of a meal or the diet.”

🔷The term antioxidant has an FDA definition, but it’s not commonly cited in warning letters. In this letter, the company was labeling some of its herbal products with the term “powerful antioxidants,” but since the product doesn’t contain ingredients with a %DV  like vitamin A, this is not a compliant claim.

🔷The warning letter also references that the cleaning products used for food contact surfaces are not for commercial food contact use. The lesson here is ensuring that the cleaning products used are suitable for food contact use and that they do not leave a residue. When I was overseeing supplement manufacturing facilities, we used food-grade hydrogen peroxide to clean food surfaces, which was also compliant with organic processor/handler regulations.

👉From warning letter. “You stated that you use Mrs. Meyer’s Clean Day Multi-Surface Concentrate as the main cleaning solution for cleaning all areas of the facility, including food-contact surfaces. This is labeled as a household cleaner, not for use on food-contact equipment in a food manufacturing facility.”

🔷The company provided a 483 response that seemed to be incomplete. As we’ve discussed many times, most 483s can be avoided with comprehensive responses. 483 responses must provide proof that the corrective action has been taken. Here, the company did not follow through on providing evidence of this.

👉The 483 responses stated in the warning letter that “all FDA-compliant Food Safety Program documentation to be completed within 3 weeks of receiving back a signed proposal, a deposit payment and a completed client intake questionnaire.”

👉FDA then responded: “We cannot fully evaluate your response because you did not submit the completed food safety program or how you will assure that your facility is compliant with all FDA requirements.”

🔷There are so many great CFR 117 learning opportunities in this letter, such as incomplete hazard analysis and labeling for major allergens and the identification and evaluation of pathogens like Salmonella in the supply chain. Determining if hazards exist and if they need preventative controls is a core principle of FSMA (CFR 117).

🔷This FDA document shows what CFR 117 regulations supplement companies must comply with. It’s also a good resource for FSMA in general. 

🔷Advisory statement labeling: We’ve all seen statements like “May be packaged in a facility that also packs nuts.” Here’s FDA clarifies this is not a substitute for GMPs.

👉 From warning letter. Advisory labeling is not a substitute for adherence to current good manufacturing practices and, when used by a facility, food allergen preventive controls.

Read the full warning letter here.

Disclaimer: The educational information provided here is for informational purposes only. Contact an attorney for specific legal advice. Rule #1 in compliance is to ensure marketing is truthful and not misleading.