From missing Analysis to Brand Protection Violations - FDA Warning Letter to Canadian Manufacturer

In September, the FDA published a Warning Letter to the manufacturer EnviroServe Chemicals & Cleaners Ltd, based in Canada. In the unusually long Warning Letter, a whole series of complaints were listed, which are summarised as follows.

1. CGMP Violations (Current Good Manufacturing Practice)

The FDA is criticising serious violations of the applicable Good Manufacturing Practice regulations (CGMP) in the production of the product SOPURE ANTISEPTIC SKIN CLEANSER:

• Failure to verify the identity of ingredients:

The company failed to adequately test raw materials used for manufacturing. In particular, ethanol, a key ingredient of the product, was not tested for impurities such as methanol. Methanol is a dangerous substance that can cause severe poisoning. There is no scientific evidence that the ethanol used meets the requirements, which poses a significant risk to consumer safety. According to FDA guidelines, ethanol must be tested for methanol to ensure product safety.

• Insufficient end product testing:

The company does not perform adequate release testing for each batch of product. Only a density measurement is performed to determine the alcohol content and organoleptic tests (odour samples) are performed to test for methanol. However, these methods are insufficient to ensure the strength and identity of the active ingredient and the presence of impurities such as methanol. Comprehensive tests must be carried out before the product is released to the market to ensure product quality.

• Lack of stability testing:

The company has not provided sufficient stability data to show that the product remains stable throughout its shelf life. There is a lack of long-term stability studies to ensure that the chemical properties of the product, particularly the active ingredient, remain stable and effective until the expiry date. The stability tests carried out to date are inadequate as they only include simple methods such as density measurements and organoleptic tests. Without adequate stability studies, it cannot be demonstrated that the product fulfils the established specifications throughout its shelf life.

• Lack of Quality Control Unit (QU):

The FDA criticised the company for not having an adequate quality control unit in place. This unit is responsible for monitoring and either approving or rejecting all ingredients, packaging materials and finished products. The FDA is concerned that the company's quality control department does not provide adequate oversight of CGMP operations. The lack of a functioning quality control unit indicates that production processes are not adequately monitored and controlled, which can lead to serious quality deficiencies.

2. Violation of the regulations for unauthorised new medicinal products

The SOPURE ANTISEPTIC SKIN CLEANSER is classified as a new medicinal product under the FD&C Act because the product claims to kill 'harmful bacteria/germs' and to be 'effective against viruses'. Such claims define the product as a medicinal product because it is purportedly intended to diagnose, cure, treat or prevent disease.

• Unapproved new drug product:

Because SOPURE ANTISEPTIC SKIN CLEANSER is a new medicinal product, the company should have obtained approval from the FDA under Section 505(a) of the FD&C Act before the product was marketed. However, the product is not approved and there is no scientific evidence or clinical studies to support its safety and effectiveness. Therefore, the product is being introduced into interstate commerce without the required approvals, in violation of the Act.

• Monograph for OTC drugs:

SOPURE ANTISEPTIC SKIN CLEANSER does not meet the terms of the FDA's temporary monograph (TFM) for topical antiseptics. The monograph only allows consumer antiseptic rubs to make claims related to the reduction of bacteria that can cause disease. However, because SOPURE ANTISEPTIC SKIN CLEANSER claims to also kill 'viruses', it exceeds the permitted claims and therefore does not comply with the applicable OTC medicinal product regulations.

3. Mislabelling (violation of trademark protection for medicinal products)

The product is mislabelled according to the FDA, which leads to several other violations.

• Misleading use of the FDA logo:

The company has used the acronym 'FDA' on its website in a form that resembles the FDA logo, claiming that the SOPURE ANTISEPTIC SKIN CLEANSER meets the 'highest standards of quality and safety.' This statement misleadingly suggests that the product has been approved or endorsed by the FDA. However, according to the regulations, registration of a product with the FDA does not mean that the product is automatically approved. This misrepresentation results in mislabelling within the meaning of 21 U.S.C. 352(a).

• Violation of the labelling regulations for OTC products:

The product contains unauthorised information on its packaging that goes beyond the information permitted by law. For example, it describes itself as a 'medical skin cleanser', which is not provided for in the applicable regulations for antiseptic liniments and consumer laundry detergents. This additional information on the product label causes the product to be mislabelled under 21 U.S.C. 352(c).

• Violation of the unapproved medicinal product regulations:

The product is also misbranded because it is marketed as an OTC medicinal product under Section 505G of the FD&C Act, but does not meet the requirements for lawful sale. Because the product does not have FDA approval, it violates the provisions of 21 U.S.C. 352(ee).

Conclusion

The FDA finds that EnviroServe Chemicals & Cleaners Ltd has committed serious violations of Good Manufacturing Practice (CGMP) by manufacturing its products without adequate testing and quality control. In addition, the product SOPURE ANTISEPTIC SKIN CLEANSER is being marketed as an unauthorised new medicine, in breach of the regulations governing the sale of over-the-counter (OTC) medicines. Finally, the product is misbranded due to misleading claims and unauthorised use of the FDA logo.

The FDA is requiring the company to take comprehensive corrective action to address these violations, otherwise legal action could follow, including a possible ban on the sale of the affected products. More detailed information can be found directly in the FDA's Warning Letter.