Sandy Almendarez, VP of Content

August 28, 2013

2 Min Read
Easily Find Warning Letters

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.

About the Author(s)

Sandy Almendarez

VP of Content, Informa

Summary

• Well-known subject matter expert within the health & nutrition industry with more than 15 years’ experience reporting on natural products.

• She cares a lot about how healthy products are made, where their ingredients are sourced and how they affect human health.

• She knows that it’s the people behind the businesses — their motivations, feelings and emotions — drive industry growth, so that’s where she looks for content opportunities.

Sandy Almendarez is VP of Content for SupplySide and an award-winning journalist. She oversees the editorial and content marketing teams for the B2B media brands Natural Products Insider and Food and Beverage Insider, the education programming for the health and nutrition trade shows SupplySide East and SupplySide West, and community engagement across the SupplySide portfolio. She is a seasoned content strategist with a passion for health, good nutrition, sustainability and inclusion. With over 15 years of experience in the health and nutrition industry, Sandy brings a wealth of knowledge to her role as a content-focused business leader. With specialization in topics ranging from product development to content engagement, creative marketing and c-suite decision making, her work is known for its engaging style and its relevance for business leaders in the health and nutrition industry.

In her free time, Sandy loves running, drinking hot tea and watching her two kids grow up. She brews her own “Sandbucha” homemade kombucha; she’s happy to share if you’re ever in Phoenix!

Awards:

Speaker credentials

Resides in

  • Phoenix, AZ

Education

  • Arizona State University

Contact:

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