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However, the 2004 proposal to specify upper concentration limits was retracted, likely due to the challenges in defining safe levels for each ingredient.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
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:
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.
For further information or collaboration opportunities, please reach out to BIOLabs PRO at 760-297-6942 or via email at email@example.com.