Topical Products Compliance

HelloPharmacist

HelloPharmacist is committed to providing high-quality dietary supplements and cosmetic products for healthcare professionals, clinics, consumers, and wellness practitioners across the United States and worldwide.

Understanding the Regulatory Environment

We often have customers, clients and partners inquire about the legality of over-the-counter cosmetic products containing bio-identical ingredients like estrogen and progesterone.

The regulatory landscape regarding cosmetic products, and their ingredients, has evolved significantly over the past several decades, and is reviewed in the sections below.

FDA's Regulatory Timeline

The FDA provides a comprehensive review of regulatory actions related to cosmetic products containing hormones. Key milestones documented in the FDA's historical records include:

  • 1982 advance notice: Initial FDA advance notice of proposed regulations
  • 1989 proposed rule: Proposal clarifying distinctions between cosmetic and drug classifications
  • 1993 final rule: Publication of the final rule detailed in Title 21 of the Code of Federal Regulations (CFR)

These documents are essential for comprehending how hormone ingredients are utilized in cosmetics and highlight the FDA's recognition of the safe use of hormone ingredients in cosmetics at specific concentrations.

FDA Clarification on Cosmetic Hormone Products

The FDA has a well-documented stance on hormone-containing products related to their intended use.

According to the FDA’s 1989 proposal (Federal Register: 54 Fed. Reg. 40369 (Oct. 2, 1989).: "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."

HelloPharmacist topical creams are intended exclusively for cosmetic use. They are formulated solely to improve skin appearance and do not make therapeutic claims or imply physiological effects. Product labeling, promotional materials, and ingredient statements do not emphasize hormone content or claim structural or functional effects on the body. Therefore, they do not meet any FDA-outlined criteria to be classified as a drug under 21 CFR §310.530.

Legal Classification and Industry Acceptance

  1. Legal Assurance: Our legal advisors concur that HelloPharmacist topical hormone 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”). They contain 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). HelloPharmacist creams containing bioidentical progesterone or estrogen are derived from wild yams and have been used cosmetically by practitioners for decades. HelloPharmacist topical creams:
    • Contain naturally sourced bio-identical ingredients from wild yam extracts.
    • Are specifically marketed for cosmetic purposes only.
    • Do not claim to diagnose, treat, cure, or prevent diseases.
    • Do not contain statements on product labeling regarding the term 'hormones', or emphasize hormone containing ingredients for any use outside cosmetic functions.
  2. Ingredient Compliance: Bio-identical hormone ingredients, including Progesterone, Pregnenolone, Estriol, and Estradiol, are neither prohibited by the FDA in cosmetics, nor are listed as controlled substances by the DEA (Prohibited & Restricted Ingredients in Cosmetics | FDA).
  3. Market Compliance: Ongoing FDA inspections of partner manufacturing facilities in Arizona verify compliance. 

Cosmetic Versus Drug: FDA's Definition

The FDA categorizes a product as cosmetic or drug based on its intended use. According to 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." HelloPharmacist products are intended for this use ONLY.

HelloPharmacist prioritizes product safety and strongly advises consumers to consult healthcare providers regarding any product influencing hormone balance.

Get in Touch

For more information or to discuss partnership opportunities, contact us at hello@hellopharmacist.com.

Additional Resources