Cheerios Aside . . . FDA Gives Guidance On OTC Labels (pdf)

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Updated April 21, 2020

The link broke in the original post.

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FDA Guidance for Industry - Labeling OTC Human Drug Products — Questions and
Answers (PDF)  found on this FDA webpage  Labeling OTC Human Drug Products -- Questions and Answers

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OK, now that we can chuckle about the Cheerios label fiasco, here's the scoop on what should go on OTC labels, "FDA Guidance for Industry - Labeling OTC Human Drug Products (PDF)"

In a nutshell, the Food and Drug Administration (FDA) has prepared this guidance in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act. It is intended to help small businesses better understand the new over-the-counter (OTC) labeling requirements set forth in 21 CFR 201.66 and prepare new labeling.

If you're new to this arena, you'll find this a real eye opener. The FDA even regulates things down to the detail of what size font you need to use, and more!

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FDA Publishes Rulemaking Histories For OTC Drugs

If you're in the Over-The-Counter (OTC), non-prescription drug business, then this FDA collection might be of some interest to you: Rulemaking History for Nonprescription Products: Drug Category List. The Over-the-Counter (OTC) drug category collection contains Federal Register notices organized by therapeutic category subtopics. Each child collection links to therapeutic category pages organized chronologically. Pretty nice. For example, you can scan the Federal Register history for something like, Hair Growth and Loss, Male Genital Desensitizers, or Weight Control. 

Related Posts: FDA Warning - Anesthetics On Skin Can Harm FDA Alert - Bowel Cleanser Warning Cold Meds For Kids - The FDA Weighs In Again 

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FDA Alert - Bowel Cleanser Warning

This is something you should read if you do 'cleanses' or are preparing for GI (gastrointestinal) or a colonoscopy procedure. Many of these related products can be found everywhere, including the corner drug store, so be aware. Read this FDA news release for the full details, "FDA Requires New Safety Measures for Oral Sodium Phosphate Products to Reduce Risk of Acute Kidney Injury Risk associated with both prescription and over-the-counter (OTC) products. The greatests risk are associated with . . .

• people over 55 years of age,
• people who suffer from dehydration, kidney disease, acute colitis, or delayed bowel emptying, and
• people taking certain medicines that affect kidney function, such as diuretics (fluid pills), angiotensin converting enzyme inhibitors (medications that lower blood pressure) angiotensin receptor blockers, (used to treat high blood pressure, heart or kidney failure) and possibly nonsteroidal anti-inflammatory drugs (similar to ibuprofen and other arthritis medications).
• FDA also warns that products should not be used by children under 18 years of age or in combination with other laxative products containing sodium phosphate

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