BIOLabs PRO®: A Leader in Bio-identical Cosmetic Products

At BIOLabs PRO, we take pride in serving a diverse clientele, including doctors, clinics, and integrative health practitioners, by offering bio-identical hormone products across the USA and globally.

Navigating the Legal Landscape

Our customers frequently inquire about the legality of selling topical products that contain ingredients such as bio-identical Estrogen and Progesterone, women’s hormones, directly without a prescription.

This issue dates back over forty years, involving FDA oversight. Pioneers like Dr. John Lee were instrumental in promoting over-the-counter cosmetic creams that contained ingredients such as Progesterone for enhancing female beauty and relieving menopause symptoms as early as the 1960’s.

FDA's Historical Perspective

The FDA's "Rulemaking History for OTC Hormone Drug Products" provides a detailed chronology of regulatory decisions on this subject. Key milestones include the FDA's 1982 advance notice, the 1989 proposed rule, and the 1993 final rule, viewable here as detailed in Title 21 - Code of Federal Regulations.  These documents are pivotal in understanding the use of hormone ingredients in cosmetics and underscore the FDA's acknowledgment of the safe use of hormone ingredients in cosmetics at specific concentrations.

FDA's Perspective on Cosmetic Hormone Use

The FDA's stance, as per the 1989 proposed rule, is clear: "The comments requested that the agency clarify that any regulation adopted as part of the OTC drug review applies to OTC drug products and not to cosmetic products for which no drug claims are made." This distinction is crucial in understanding the legal context of our products.

A significant excerpt from section 47609 of the FDA's rule illustrates the agency's approach to regulating hormones in cosmetics, proposing to identify these hormones and their upper concentration limits in cosmetic products. This perspective is further elaborated in section 700.20, stating the safe use of pregnenolone acetate and progesterone in cosmetics.

However, the 2004 proposal to specify upper concentration limits was retracted, likely due to the challenges in defining safe levels for each ingredient.

Legal and Market Acceptance

  1. The FDA's position is clear: topical hormone-containing products are considered drugs only if intended as such. This distinction is evident in the FDA's 1989 statement, emphasizing that products without drug claims fall outside the scope of drug regulations.

  2. Legal counsel for BIOLabs PRO concurs with this interpretation, asserting that our products, comprised of natural compounded ingredients and intended for cosmetic use, do not fall under the drug category as per the Federal Food, Drug, and Cosmetic Act.

    The BIOLab PRO Products are not drugs as defined by sections 201(g)(1)(B) and/or 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) because they contain only natural compounded ingredients, are not intended to cure, mitigate, treat, or prevent disease, and are not intended to affect the structure or function of the body.  See 21 U.S.C. §§ 321(g)(1)(B), 321(g)(1)(C).  Rather, the BIOLab PRO Products are topical cosmetic creams that contain bioidentical progesterone or estrogen derived from wild yams.  The FDA acknowledges that these non-FDA-approved cosmetic products are sold through ordinary retail channels and have been used by natural and homeopathic practitioners for cosmetic reasons for decades.  See 21 C.F.R. § 310.530.
    Casey Hewitt
    Hewitt Law PLLC
    15 Main St., Ste 1 | Littleton, NH | 03561
  3. Notably, bio-identical ingredients like Progesterone, Pregnenolone, Estriol, and Estradiol are not listed on the FDA's Prohibited Ingredients list for cosmetics, nor are they classified as DEA Controlled substances.

  4. Our experience confirms the general acceptance of these products' legality. Regular FDA inspections of our facilities have not raised objections to our products. Additionally, these products are available in various retail stores and online platforms, adhering to strict compliance standards.

  5. The FDA's definition of a cosmetic versus a drug hinges on the intended use of the product, as outlined in the Federal Food, Drug, and Cosmetic Act. Our products, intended for beautification and not for medical treatment, align with the cosmetic classification.

FDA's Cosmetic vs. Drug Distinction

The FDA categorizes a product as a cosmetic or a drug based on its intended use. As per the FD&C Act, cosmetics are "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance."

Conclusion and Guidance for Partners and Wholesalers

In conclusion, the legality of hormone ingredients in cosmetic products primarily depends on marketing and labeling. As long as these topical products are not marketed with medical claims, they are considered legal for sale without a prescription.

We advise our Private Label partners on the following:

  • Ensure appropriate product titling and avoid labeling them as “Hormone Creams.”
  • Include the FDA drug disclaimer on labels, “this product in not intended to treat, cure, or prevent any disease.”
  • Refrain from making medical claims on labeling and marketing materials.

This approach ensures compliance and aligns with FDA regulations.

BIOLabs PRO remains committed to the safety and efficacy of our products and recommends that customers consult with healthcare providers regarding any products affecting hormone levels.

Contact Us

For further information or collaboration opportunities, please reach out to BIOLabs PRO at 760-297-6942 or via email at partner@biolabspro.com.

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