The Food and Drug Administration, on February 3, 2021, issued a warning letter to Botanicals Internacional S.A. de C.V. that its hand sanitizer could not be admitted into America.
Why FDA found that the hand sanitizer was not in compliance with the FD&C Act
The warning letter was sent to the president of the company after the FDA tested a consumer antiseptic rub drug product (also called a hand sanitizer). The product’s label stated that the product, identified as inatek HAND SANITIZER, was manufactured at the company’s facility. The attempt to import this drug product into the US was detained at the border.
FDA stated that the agency tested a batch of the product and found the following violations:
- Adulterated product. As a result of the test, FDA found that the product was “adulterated” within the meaning of the Food, Drug, and Cosmetic ACT (FD&C Act) Section 501 (d)(2) because a “substance was substituted in whole or in part.”
- Current Good Manufacturing Practices noncompliance. FDA also determined that the hand sanitizer product was adulterated because the substation indicates that FDA’s requirement for (CGMP) requirements was not met.
- An unapproved new drug introduced or delivered into interstate commerce. FDA found that the company’s introduction of the inatek HAND SANITIZER is an unapproved new drug introduced or delivered for introduction into interstate commerce “in violation of section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and is misbranded under sections 502(j), (a), (e), and (ee) of the FD&C Act, 21 U.S.C. 352(j), (a), (e), and (ee).” The violations were further detailed in the warning letter.
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FDA found that the hand sanitizer was adulterated because “the product label indicated that the hand sanitizer contains 70% volume/volume (v/v) of the active ingredient ethyl alcohol (ethanol). FDA lab tests found that the product – instead – contained 75% (v/v) methanol and an average of 0.2% (v/v) ethyl alcohol, which is 0.3% of the amount of ethyl alcohol described on the label.”
Due to this variation – the use of methanol (a dangerous chemical when humans ingest the chemical or the chemical comes into contact with human skin) for the active ingredient of ethanol – FDA determined that the product was adulterated.
“Methanol is not an acceptable ingredient for hand sanitizers and should not be used due to its toxic effects.” If a consumer’s skin is exposed to methanol, the consumer can suffer dermatitis. Consumers may also suffer “transdermal absorption with systematic toxicity.” Other consequences from exposure to methanol include vomiting, headaches, nausea, vision disorders include the possibility of permanent blindness, coma, seizures, nerve damage, or death. Methanol is especially dangerous for anyone who drinks these products as a substitute for alcohol.
FDA stated that the agency did not contact the company about removing the product from the market because all of the inatek Hand Sanitizer products were denied entry into the United States. The products manufactured by the company were placed on Import Alert 66-78. FDA also informed the public of the methanol contamination of your drugs at the following website:
FDA Response to the manufacturer’s letter of explanation
On July 27, 2020 (and on subsequent dates), the company that made the hand sanitizer informed FDA that the company discovered the methanol contamination through the company’s own investigation – and stated the company believed the contamination was due to just one supplier. But FDA stated that the company
“initially released the contaminated drug products from your firm for subsequent distribution without exercising adequate controls to ensure that the necessary quality attributes were met for both your finished drug products and their raw materials.”
FDA advised the company to provide:
- A more current investigation into the hand sanitizer – and that the company should include a review of the CGMP failures that played a part in the distribution of the dangerous material (the methanol).
- “A list of all batches of any hand sanitizer drug products shipped to the United States by your firm, and a full reconciliation of all material you distributed.”
- Copies of the full batch records for the products distributed to America
- A list of the raw materials the company uses to make the hand sanitizer drug products – including identifying the suppliers by – name, address, and contact information.
- Explain why the company couldn’t detect the prior manufacturing failures.
CGMP failures
FDA stated that the methanol contamination in the hand sanitizers showed that the companies quality assurance at the manufacturing site wasn’t in compliance with the FD&C Act’s Current Good Manufacturing Practice (CGMP) requirements.
Unapproved New Drug and Misbranding Violations
FDA further determined that the company’s inatek Hand Sanitizer qualifies as a “drug” within the meaning of the FD&C Act – because the products “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, this product is intended as a consumer antiseptic hand rub.”
FDA, as the agency often does, reviewed claims on the label of the product to support the determination that the intended use of the sanitizer was a drug based on the following:
- “Drug Facts . . . Antiseptic [.]
- Use: hands (sic) sanitizer to help decrease bacteria on the skin . . .
- Direction: Put enough product in your palm to cover hands and rub hands together briskly until dry….”
FDA stated that the product is a “new drug” because the product isn’t “generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling.”
The warning letter advised the foreign manufacturer that “new drugs” can’t be introduced or delivered into interstate commerce – unless the drugs have prior FDA approval – or unless they are marketed lawfully under the terms of the FD&C Act – or unless other exceptions apply. FDA stated that no current FDA-approved application is in place for this hand sanitizer product. The agency also stated that there are no controlled clinical studies “in the published literature that support a determination that your inatek HAND SANITIZER drug product is GRASE for use under the conditions suggested, recommended, or prescribed in its labeling.”
FDA also noted that “over-the-counter (OTC) topical antiseptic products had been the subject of rulemaking under the Agency’s OTC Drug Review.” “Over the course of these rulemakings, benzalkonium chloride, ethyl alcohol, and isopropyl alcohol were classified as Category III for use as active ingredients in consumer antiseptic rub products, meaning that additional safety and effectiveness data are needed to support a determination that a drug product containing one of these active ingredients would be GRASE for use as a consumer antiseptic rub.”
Misbranding of the hand sanitizer
FDA also found that the inatek Hand Sanitizer with the methanol – was a misbranding under the terms of the FD&C Act because the product is “dangerous to health when used according to its labeling as a hand sanitizer.”
FDA stated that if a consumer’s skin is exposed to methanol – that could cause systemic absorption. Further exposure could cause blindness, nerve damage, and possibly death. The product is “misbranded” under the provisions of the FD&C Act because the label is “false and misleading.”
The label states that the product contains ethyl alcohol 70%. But the lab analysis shows that the sample that was tested contains “less ethyl alcohol (ethanol) than indicated on the labeling and instead contains a significant concentration of methyl alcohol (methanol), an ingredient that is not declared on the product label.”
In concluding that the hand sanitizer produce is misleading (and thus misbranded), the agency reviewed the FD&C Act.
“Section 201(n) of the FD&C Act, 21 U.S.C. 321(n), provides that “in determining whether the labeling or advertising is misleading there shall be taken into account . . . not only representations made or suggested . . . but also the extent to which the labeling or advertising fails to reveal facts material in the light of such representations or material with respect to consequences which may result….”
The misleading representation is that the product includes a specific concentration of ethanol – when the product does not and the failure of the label to disclose the presence of the methanol.
The product is also misbranded because the inatek Hand Sanitizer is a “nonprescription drug 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.” Introducing or delivering misbranded drugs into interstate commerce violated the FD&C Act.
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The recommendation of a consultant
The FDA warning letter responded to the July 17, 2020 letter in which the company stated the company retained a “qualified GMP consultant to review the company’s quality system and procedures.” The response indicated that the manufacturer did not identify the consultant and did not provide written documentation of the consultant’s qualifications – to show why the consultant could properly help the manufacturer regain compliance.
FDA does recommend that the company hire a consultant to evaluate the operations of the manufacturer and to help the company meet its CGMP requirements – if the company does want to introduce its products into the US market. FDA also recommends that the consultant conduct a thorough audit of the company’s operations.
An alternative to hiring a consultant would be to hire an experienced FDA compliance lawyer.
FDA stated that there may be other violations so the company should conduct a thorough review of any other possible violations of the FD&C Act. In the meantime, the import hold on the products will continue.
FDA advised the company’s president that he could request a “regulatory meeting “to review the corrective actions. FDA gave the company 15 days to respond – electronically.
FDA issued a warning letter to a foreign manufacturer of a hand sanitizer after the manufacturer tried to import the product into the United States. The warning letter focused on the false label on the hand sanitizer. The label falsely represented that the product contains a specific percentage of ethanol and falsely omitted that the hand sanitizer contained methanol. FDA warned the company and its president that the product is adulterated, misbranded, is an unapproved new drug, and fails to comply with Current Good Manufacturing Practices.
Drug manufacturers should contact Cohen Healthcare Law Group, PC for legal advice on the FD&C Act and how to respond to FDA warning letters. Our experienced healthcare attorneys provide legal review of federal and state compliance laws.
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