August 28, 2013
This industry needs to be aware of the warning letters FDA sends to dietary supplement companies. They show trends in FDA's regulatory thinking as well as common violations of GMPs (good manufacturing practices) and marketing claims. While it's smart to stay updated on the new letters that are released each Tuesday, it can be a cumbersome task to navigate FDA's website.
FDA houses all its warning letters in one place; letters sent to food, drug and medical devise manufacturers are jumbled up with the supplement letters. FDA lists the reason for sending the warning letter next to each letter, and some are easier to decipher; for instance, some are labeled "CGMP for Dietary Supplements" making it obvious it applies to our industry.
However, some warning letters are to companies for claims that make them drugs in FDA's opinion, so the agency won't label them as "supplements." In this case, they are called "New Drug/Labeling/Misbranded." A busy supplement marketers who is quickly skimming these letters could easily miss those critical letters.
INSIDER has made it easy to all the find warning letters applicable to the dietary supplement industry in our Warning Letter Immersion Center. Updated weekly, the Warning Letter Immersion Center has an easy-to-understand table that shows the name of the company, the reason(s) for FDA issuing the letter (GMPs, Claims, Labeling and/or Adulteration), and a link to FDA's letter or INSIDER news about that specific letter. The Immersion Center is a quick, easy way to find warning letters for specific violations, and we provide an easy way to get more information if that's what you're looking for.
Plus, we also offer featured content that explains the greater warning letter trends and how the letters affect the industry. You can find a Digital Issue on immune health marketing, a Report on cGMP expertise and much more. We also have feeds to the latest blogs, news posts and slide shows that also offer information on warning letters.
The INSIDER Warning Letter Immersion Center reduces the time it takes an executive to figure out why FDA sends warning letters, ensuring a company can stay legally compliant while also keeping education efficient. I encourage you to bookmark it and check it weekly. It will save you time, and could save you from being the next company on the warning letter list.
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