GMP Lessons For Distributors

Distributors are responsible for the products they hold and distribute. Here, I review a recent warning letter where the company was cited for GMP and labeling issues, and there are some excellent learning opportunities here.

🔹Listing mandatory nutrients: The cod liver oil product’s serving size is 5mL, but there are no calories, Total fat, or vitamin D listed in the supplement fact panel. These are some mandatory nutrients that must be listed if they are above the “zero level” per serving. For example, four calories is a “zero level,” but five or more calories must be declared. AHPA has some excellent guidance on this if you are a member, or here’s a link to the FDA regulations that are unfortunately a little clucky.  Supplement Advisory Group, my consulting company, can help make your label and supplement fact panel compliant. Please contact me with your label compliance needs.

🔹DSHEA disclaimer: If there are structure-function claims on a label, the company must add the DSHEA disclaimer and correlate it with a symbol. Unfortunately, plaintiff attorneys have been using this regulation for lawsuits in the past two years. This is because the rules state the disclaimer must be on each label panel where the claim occurs.

  From warning letter. “The label makes structure-function claims but fails to bear the required dietary supplement disclaimer in accordance with 21 CFR 101.93(b)”

🔹Adverse Event Reporting address: This is an essential part of the safe regulation of supplements.

  From warning letter. “The labels fail to bear a domestic address or domestic phone number through which the responsible person (as described in section 761) may receive a report of a serious adverse event with such dietary supplement.”

🔹Multiple languages: If a label lists information in two languages, the supplement fact panel must also be listed in both languages. This is a regulation I did not know about since I have only worked with English labels.

  From warning letter. “If a product label contains any representation in a foreign language, all words, statements, and other information required by or under authority of the Act to appear on the label must appear in the foreign language. The product includes foreign language on the label but fails to declare all subsequent information in the Supplements Facts label in both languages as required.”

🔹Statement of identity: The product has a supplement fact panel but “Supplement” is not listed in the Principle Display Panel.

Now the GMP issues.

🔹Storage must match label instructions. This one is interesting. The label lists a storage temperature, but the distributor apparently did not have procedures to control for this.

  From warning letter. “Your procedure does not include instructions on how to appropriately store these products based on the storage temperatures indicated on the product labels.”

🔹Designated quality personnel. Distributors must have qualified and trained quality personnel. Some SOPs, employee time allocation, and training could have avoided this part of the warning letter.

  From warning letter regarding their 483 response. “These documents assign the product receiving responsibility to the Purchasing Department, including the review of shipment documentation. However, neither document provides your firm’s quality control procedures for dietary supplement products, such as written procedures for conducting a material review and making a disposition decision in accordance with 21 CFR 111.113, including products contract manufactured for your firm’s own label.”

There is a lot more to this warning letter. Read the full letter. 

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.