Tune Up Your FDA Compliance!

By Curtis Walcker, M.S.
January 27, 2022

It’s difficult fix a problem if you don’t know there is one to begin with – which is the case with many clients we work with. So, we’ve compiled a brief set of checks that you can quickly and easily self-audit with. While very far from being all-inclusive, these checks touch on some of the lowest-hanging fruits and most common violations seen. If you recognize one or more with your brand, it doesn’t guarantee you are violating regulations, but it would be a strong indication that you have something to look at.

Red Flags

Labels:

  • Are any of your botanical plant parts declared as “aerial parts” or “herb”?
  • Are there any zeros (e.g., 0 mg or 0 g) in the Supplement Facts panel?
  • Are you missing a U.S. phone or address where adverse events can be reported?

Claims:

  • Are you making explicit or implied claims about COVID, flu, or cold?
  • Do you have any unqualified inflammation or pain claims?
  • Are you making claims about hangovers?

Manufacturing:

  • Do your certificates of analysis (COAs) list “by input” as the only testing method to ensure label claims specifications are met?
  • Is your manufacturer registered with the FDA?
  • Do you not have and follow your own set of written procedures (SOPs) for things not conducted by you manufacturer or other contracted partners (e.g., returned dietary supplements, product complaints, reserve samples, supplier qualification, etc.)?

Ingredients:

  • Does your product contain cannabidiol (CBD)?
  • Does your product contain n-acetyl l-cysteine (NAC)?
  • Does your product contain kratom?

Could you answer “yes” or even “I don’t know” to any of these? If so, it’s not necessarily a reason to panic, but you should be concerned. Sometimes brands take calculated risks because the potential reward might out-weight them. But other times, they take uncalculated risks because they are unaware, see other brands doing something, or they are just marketers that do not know or care about following the rules. In any case, we are here to help. If you have something questionable, we can help determine if you are at risk, explain to you why you are at risk, and help you make the corrective actions to reduce or remove the risk. Contact us today to get a free assessment of your situation.

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