Health and Natural Beauty USA Gets FDA Warning Letter

The United States Food and Drug Administration (FDA) inspected Health and Natural Beauty’s manufacturing facility, Health and Natural Beauty USA Corp., Piscataway, NJ in October 2024. FDA issued a Warning Letter, Health and Natural Beauty responded, but the Agency found the response to be inadequate.

FDA concluded several toothpastes are unapproved new drugs and misbranded. More specifically, FDA found CGMP violations, such as failing to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)).

Furthermore, Health and Natural Beauty failed to establish adequate written procedures for production and process control designed to assure that the drug products manufactured have the identity, strength, quality and purity they purport or are represented to possess. (21 CFR 211.100(a)).

Health and Natural Beauty failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and (d)).

CGMP Consultant Recommended

Based upon the nature of the violations identified, FDA recommended Health and Natural Beauty hire a consultant qualified as set forth in 21 CFR 211.34 to evaluate operations and to assist in meeting CGMP requirement.

In addition, FDA noted some products may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics manufactured must comply with applicable statutory and regulatory requirements, including the FD&C Act. Further, the facility may be subject to requirements of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).