FDA sends CBD warning letters to five companies - Food Business News

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According to the article:

"The US Food and Drug Administration on Dec. 22 issued five warning letters to companies for selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act. The five companies illegally were marketing unapproved CBD products claiming to treat medical conditions, according to the FDA."

Read the full source article:   FDA sends CBD warning letters to five companies - Food Business News

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FDA Warns Companies Illegally Selling Hangover Remedies - FDA.gov

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Read the full news release:  FDA Warns Companies Illegally Selling Hangover Remedies - FDA.gov

According to the article:

... "the U.S. Food and Drug Administration announced it has issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters were issued to: Double Wood LLC; Ebnsol Inc.; Vita Heaven LLC (doing business as Hangover Heaven); Happy Hour Vitamins; LES Labs; Mind, Body & Coal LLC; and Purple Biosciences LLC."

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FDA warns 15 companies for illegally selling various products containing CBD - FDA.gov

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FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns - FDA.gov

Violations include marketing unapproved new human and animal drugs, selling CBD products as dietary supplements, and adding CBD to human, animal foods

According to the FDA news release:

"Today, the U.S. Food and Drug Administration issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food."

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FDA aims high in crackdown on CBD manufacturers - in-PharmaTechnologist

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24-Jul-2019 By Ben Hargreaves

US FDA took aim at the ‘world’s largest cannabis’ company for making ‘unfounded claims’ about the therapeutic potential of its CBD products.

https://www.in-pharmatechnologist.com/Article/2019/07/24/FDA-sends-warning-letter-in-crackdown-on-CBD-claims?utm_source=copyright&utm_medium=OnSite&utm_campaign=copyright 

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FDA warns company marketing unapproved cannabidiol products - FDA.gov

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Read the full news release:  FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety  -  Agency is expediting work to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD - FDA.gov

According to the news release:

"... the U.S. Food and Drug Administration announced that it has issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.  ... 

The FDA has previously sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the Federal Food, Drug and Cosmetic Act because they were marketed as dietary supplements or because they involved the addition of CBD to food."

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In-Person Ways to Avoid Form 483 Observations and Warning Letters | MDDI - Free Tips

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Read the full article for free tips: In-Person Ways to Avoid Form 483 Observations and Warning Letters | MDDI Medical Device and Diagnostic Industry News Products and Suppliers:

"For many medical device companies, it's a scary idea that an FDA inspector could show up at your reception desk tomorrow—or even today. Device executives need to ensure that everyone, from their regulatory affairs team to their receptionist, know how to interact with FDA personnel."

'via Blog this'

#free #tips

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CRN FDA GMP Warning Letter Database - For Dietary Supplements - Free

Read the full press release: CRN FDA GMP Warning Letter Database Document:

"The Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry, today announced a free online tool that compiles FDA Warning Letters sent to dietary supplement companies into a searchable database to help industry achieve better regulatory compliance. The database can be used to evaluate FDA’s warning letter allegations of good manufacturing practices (GMPs) violations, products making impermissible claims, and products tainted with illegal ingredients."

'via Blog this'

Access the CRN FDA Warning Letters Database for Dietary Supplements

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FDA Wants Resource Planning In Corrective Action Plans

According to the The QA Pharm blog,

"The most successful corrective action plans have been those where the direct responsible individuals are named and appear in detailed project plans. There is a clear picture of what success looks like and how to get there. But most of all, the resources are identified to execute the work."

Apparently in an FDA Warning Letter to Teva early this year,  the FDA is telegraphing their desire to see these kinds of elements in a response:

• a plan
• what kind of data will be collected to measure the effectiveness of the plan
• a timeline for the plan
• the identification of resources allocated to address the issue

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FDA Updates Warning Letters Web Page

The U.S. Food and Drug Administration has reorganized and updated the warning letters page in the Inspections, Compliance, Enforcement, and Criminal Investigations section of the FDA Web site. The changes on the Web page are as follows:

• Every Tuesday, the most recently issued warning letters now will be presented under Recently Posted with the date posted.
• Effective Sept. 1, the Close Out Date is now provided in the Warning Letters table and detailed information about the Warning Letters Close Out Program is provided.
• Additional changes include formatting and improved page navigation to help users understand what searching and browsing options are available.

The “Warning Letters” page can be found at: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm. The FDA will continue to look for ways to improve the “Warning Letters” webpage in the future.

Previous Posts: Food Industry Ramifications of the FDA Cheerios Warning Letter FDA Warning Letter - Space Shuttle Fruitcake

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CAPA Problems - Most often cited 483 deficiency

You'll do well by reading this well-written article by Barbara Immel, "Converting CAPA to an Advantage - CAPA violations still generate a substantial number of warning letters. These tips can help make CAPA systems a benefit instead of a liability." Her writings are packed full of great content. Don't miss out on these pearls of wisdom and well referenced article.

In concluding, she writes, "CAPA deficiencies are one of the most common items cited in warning letters to medical device manufacturers. Therefore, it is critical for manufacturers to understand how to develop a CAPA system and how best to use it. . . ."

Related Posts:
Free FDA Compliance Library (Immel Resources LLC - Pharmaceutical, Medical Device, Biologics and Related Industries)
FDA Says - Unwise To Ignore Form 483
Medical Device Sponsors - FDA Trends and Tips To Avoid 483s
More FDA 483 Resources - Comments and Pearls from Validation Online
FDA 483 Inspectional Observations - learn from these examples

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FDA Warning Letter - Space Shuttle Fruitcake

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Updated March 6, 2019

WSJ put the article behind their subscription wall, and the link to the warning letter has broken.

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FDA: Pardon Me, But Your Bakery Warehouse Is Full Of "Rodent Excreta Pellets" - Consumerist

---  original post follows below  ---

This would be amusing if it wasn't so serious. I recommend you read this, and share it during an upcoming GMP training or classroom session. At first, I was slightly amused and drawn to this WSJ article by its headline, "Pay No Attention to the Mice Behind the Pallets." Then I read, and was appalled. Read on and take a gander at the FDA warning letter to Capitol Cake Co. BTW, they've proudly supplied fruitcake for the space shuttle program.

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