FDA Finds More False Coronavirus Claims

The US FDA continues to crack down on companies—including firms selling hand sanitizers and related products—that are making false and misleading claims related to coronavirus.
 
In early June, FDA sent a warning letter to Quadrant Sales & Marketing, Inc., Clearwater, FL, following a reviewed its website on April 30, 2020. The FDA has observed that the firm’s website offers a non-alcohol based hand sanitizer product, known as Purifi, for sale in the US and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. Based on FDA’s review, this product is an unapproved new drug sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). The introduction or delivery for introduction of this product into interstate commerce is prohibited under section 301(d) of the FD&C Act, 21 U.S.C. § 331(d), said FDA.
 
Some examples of the claims included: 

“What does Purifi™ kill? Purifi™ protects by killing bacteria, viruses, mold, mildew, fungi, algae and yeast on contact. In addition, it destroys odor causing bacteria, both gram negative and gram positive. Although not on our label, extensive third-party testing has conclusively proven that Purifi™ destroys all three – MRSA, C. Diff. and H1N1 – as well a wide array of other viruses. Under the present regulatory environment, the product is certified against Corona Virus. As there are 1000’s of viruses, the antimicrobial industry is allowed to certify based on model organisms for the main categories of virus: enveloped, non-enveloped, RNA, DNA, various families, etc. For the family of Corona Virus, the human Influenza A or sub-set H1N1, is the model which the product on which Purifi™ Hand Sanitizer is based has been tested to destroy/ inactivate.”

“Purifi™’s fast drying lightweight foam forms a germ fighting breathable microscopic barrier that lasts for hours and persists through hand washing.”
In addition, FDA cited examples in which the company called Purifi a “next generation hand sanitizer” that had a formulation lasts for hours.

According to the FDA letter, Purifi “applies a breathable soap-silicon protective barrier to your hands, continuously destroying harmful germs and disrupting germ adhesion to your skin. . . The patented antimicrobial technology safely kills microbes on contact. It is not absorbed by the skin but instead bonds to the surface for up to 24-hours. As your skin sheds daily, the Purifi™ comes off. For maximum protection, application every 6 hours is recommended.”

Based on the above claims, your hand sanitizer product is a drug as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. § 321(g)(1)(B), because it is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. § 321(g)(1)(C), because it is intended to affect the structure or any function of the body. Specifically, the hand sanitizer is intended for use as a consumer antiseptic rub, noted FDA.

FDA said the hand sanitizer product is a new drug because it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. The agency also noted that  no FDA-approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. § 355, is in effect for the firm’s hand sanitizer product, nor was it aware of any adequate and well-controlled clinical studies in the published literature that support a determination that the hand sanitizer product is GRASE for use under the conditions suggested, recommended, or prescribed in its labeling. 

Additionally, StayWell Copper Products, Fort Collins, CO, was cited by the FDA and FTC after reviews of its website and social media pages between May 20-26, 2020.

The FDA has observed that StayWell’s website offers copper “Germ Stopper” products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19[ in people. Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).

Some examples of the claims that FDA and FTC took issue with included: 

“We at StayWell™ Copper consider our products as non-messy, non-chemical alternatives to bottled hand sanitizers. The details of the chemical reactions involved in copper’s natural antimicrobial properties vary by microorganism, but the science shows that there is an ionic exchange between the copper surface and the microorganism. Whether there’s a cell wall as with bacteria and fungi, or a membrane, as with many but not all viruses (COVID-19 has a membrane or envelope holding in the rest of the viral contents) the effect copper has on the microorganism is the same: it is disrupted.”   

Additionally, FDA said the company stated: “Staywell Copper is a natural, germ-killing alternative to hand sanitizers, giving you a powerful layer of protection against germs such as Coronavirus, as well as MRSA, e. coli and many more. By rubbing your StayWell Copper regularly, you have the peace of mind that pure copper is killing 99.97% of germs on your hands. Touch is one of the main ways germs are transmitted, so keeping your hands germ-free with StayWell Copper rollers, tags and patches is a great way to prevent transmission of germs.”