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INSIGHTS

April 20, 2023

Is My Hand Sanitizer a Food? A Cosmetic?

No! FDA Reminds Consumers that Hand Sanitizers are Regulated as Over-the-Counter Drugs

 

With new marketing of hand sanitizers touting food flavors or fragrances, FDA recently issued a consumer notice, reminding consumers that the FDA regulates hand sanitizers as Over-the-Counter (OTC or non-prescription) drugs. Companies may market OTC drugs in the U.S. without FDA clearance, if the drugs comply with an OTC drug monograph, which details acceptable ingredients, doses, formulations, and labeling.

Following the discovery of serious safety concerns during testing, the agency further reminds consumers to read and follow the Drug Facts Label, specifically the warning section.  The FDA advises to avoid hand sanitizers that are contaminated with potentially toxic types of alcohol, that do not contain enough active ingredient (ethyl alcohol or isopropyl alcohol), or that have labels containing false, misleading or unproven claims.

Specifically, and following issues with methanol contamination during the COVID-19 pandemic, FDA urges consumers not to use hand sanitizer products that:

  • Have been tested and found to contain methanol, 1-propoanol, benzene, acetaldehyde, or acetal
  • Is labeled to contain methanol
  • Has been tested and is found to have microbial contamination
  • Is being recalled by the manufacturer or distributor
  • Does not have the required amount of active ingredient (e.g. ethyl alcohol, isopropyl alcohol, benzalkonium chloride)
  • Is packaged in a container that resembles a food/beverage container that presents risk of accidental ingestion
  • Is manufactured at a facility that is under FDA review for manufacturing compliance

 

Companies involved in the manufacturing, processing and distribution of hand sanitizers must ensure compliance with FDA’s OTC Rulemaking on Hand Sanitizers (known also as topical consumer antiseptic rub products) to avoid FDA enforcement action. This involves compliance with formulation requirements (type and amount of active ingredient), and indications. This also involves compliance with drug establishment registration and listing, labeling requirements for OTC drugs, and with Good Manufacturing Practice (GMP) requirements.

If you are a business involved in manufacturing, including contract manufacturing, or processing of the finished dosage form of an OTC drug, you may also be subject to OMUFA (Over-the-Counter Monograph User Fee Act) facility fees. Note that FDA has advised that it will not assess OMUFA facility fees for FY2023 on firms that first registered with the FDA after the declaration of the COVID-19 public health emergency solely for purposes of manufacturing OTC hand sanitizers during the public health emergency. FDA expects to provide additional guidance on facility fees and hand sanitizer manufacturers that continue to remain on the market going forward. However, FDA has advised that whether a business is subject to OMUFA fees has no effect on FDA’s ongoing enforcement tools to regulate hand sanitizers and other OTC-regulated products.

For any questions on the marketing requirements of OTC drugs, please contact us at info@garg-law.com.

★★★★★

Working with Shelly on various new product launches over the last couple of years has been seamless. Quick and clear guidance is always what we get.
R.G. Client
I've been working with Shelly and her team at Garg law for a little while now and they are fantastic! Very responsive, professional and they certainly get things done. Extremely satisfied with their service and highly recommend.
Mike H. Client
Ms Garg helped my company navigate an FDA import issue. She achieved an excellent result, was very responsive and professional, and managed to keep the project within budget. She is a stellar attorney.
Dr. Sastry Client
I have been using Shelly Garg as FDA Counsel for 10+ years, since she was at another international law firm. While we continued to use the previous firm she was at (mainly due to the process required to change firms), we realized the quality of counsel was not the same. We have since been using Garg Law and the ease of use and trust in the knowledge was back instantly. Shelly has the skills to help me understand the regulations (by translating into layman's terms) and risks in a manner that is specific to my business. She is also extremely timely in her responses which is critical when we have a deadline mandated by the FDA. Many other attorneys cite the regulations which l've already read, but need further counsel. In my opinion, this demonstrates Shelly's in-depth knowledge of the regulations, how they pertain to the law, and how they are applicable IRL. Shelly's personable approach and pleasant manner in communication makes it very easy to have been work with her and have productive discussions on the best next steps. She truly has a passion iternational for all things FDA and I've learned so much from her.
Claire P. Client

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