Increasing attention on the antimicrobial properties of copper triggered by the COVID-19 pandemic has motivated some manufacturers to advertise new or existing copper-based products with potentially inappropriate or unsubstantiated public health claims that are not supported by credible science and/or EPA registration as required by the U.S. Federal Insecticide Fungicide and Rodenticide Act (FIFRA).
Copper products marketed with potentially misleading antimicrobial efficacy claims risk damaging industry reputation and the credibility of legitimate market participants that have secured the appropriate regulatory approvals and advertise their products responsibly in alignment with EPA-registered product labels.
CDA is obligated in its EPA-mandated Stewardship role to contact manufacturers making inappropriate antimicrobial claims about copper-based products and provide them with information on EPA regulatory and registration requirements and the proper use and care of antimicrobial copper materials. However, CDA is not an enforcement body and it is impractical to follow-up with each of the myriad companies making potentially misleading claims.
Considering the points above, CDA’s position is as follows:
- CDA will use its discretion to send Stewardship communications to select companies making egregious claims about copper-based products.
- Key criteria include: nature of offending claims, size of company and distribution network, type of product/application and the extent to which copper alloy EPA registrations and supporting science have been misappropriated
See PDF at the link below for a generic CDA Stewardship communication.
Independent of CDA's Stewardship actions, anyone can anonymously report suspected violations by completing this simple form on EPA’s website.
EPA has directly acknowledged the increase in companies making fraudulent antimicrobial claims about the COVID-19 virus and has taken steps to increase market monitoring and enforcement actions as outlined in a recent notice.
Additionally, the Food & Drug Administration (FDA) and the Federal Trade Commission (FTC) are taking urgent action to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 disease in people. A manufacturer of a copper-based product received a warning letter from FDA/FTC for misleadingly representing their products as safe and effective for a COVID-19 related use which constituted a violation under section 502 of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 352. A redacted copy of the letter is included below to illustrate examples of unacceptable claims made for copper-based products.
CDA urges manufacturers of new and existing copper-based products to carefully review the relevant EPA, FDA and FTC regulations and ensure the appropriate approvals have been secured before making any antimicrobial effectiveness claims. Furthermore, manufacturers that have secured these approvals should ensure product claims are consistent with approved labels. CDA has prepared guidance to assist manufacturers on the following page: Antimicrobial Copper Product Development Guidance
*Laboratory testing shows that, when cleaned regularly, antimicrobial copper surfaces kill greater than 99.9% of the following bacteria within 2 hours of exposure: MRSA, VRE, Staphylococcus aureus, Enterobacter aerogenes, Pseudomonas aeruginosa, and E. coli O157:H7. Antimicrobial copper surfaces are a supplement to and not a substitute for standard infection control practices and have been shown to reduce microbial contamination, but do not necessarily prevent cross contamination or infections; users must continue to follow all current infection control practices.
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