Disinfect & Shield

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Accordingly, this product is an unapproved new drug marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C §§ 355(a) and 331(d).

Passage 2

In addition, DISINFECT™ & SHIELD HAND SANITIZER is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. § 352(a), because your firm’s website misleadingly implies that FDA has endorsed or approved your DISINFECT™ & SHIELD HAND SANITIZER products in some manner. For example, you display the phrase “FDA Listed.” In that presentation, the term “FDA” appears in a unique graphical form used as the agency’s official logo for many years. Additionally, you state your products are “FDA Registered.” To state that any drug product is “FDA Registered” is inaccurate; drugs are subject to listing with FDA, not registration. Moreover, registration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or any other drugs of the establishment, nor does it mean that a product may be legally marketed. (21 CFR 207.77(a)). This language is misleading because the general public is not likely to be familiar with the details of FDA regulation. The use of “FDA Listed” with the agency’s official logo and “FDA registered” to describe your products misleadingly suggests that your products are approved or endorsed by FDA in some way when this is not true. Thus, DISINFECT™ & SHIELD HAND SANITIZER is misbranded under section 502(a) of the FD&C Act, 21 U.S.C. § 352(a), because its labeling is false or misleading in any particular.

Passage 3

Lastly, DISINFECT™ & SHIELD HAND SANITIZER is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. § 352(ee), because DISINFECT™ & SHIELD HAND SANITIZER is subject to section 505G of the FD&C Act, 21 U.S.C. § 355h, but does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. § 355.