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.
