FDA Warns Pharmagel

After a review of its website, the US Food and Drug Administration (FDA) has issued a warning letter to Pharmagel, Chatsworth, CA. FDA noted that several products, including  Beta-C, Bio-A Concentrate, Eye Firmé, Pharma Clear Medicated Moisturizer and Slender Shaper, appear to be promoted for uses that cause the products to be drugs under section 201(g)(1)(B) and (g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B) and (g)(1)(C)]. 


According to FDA, the claims on the Pharmagel website indicate that the products are intended for use in the cure, mitigation, treatment, or prevention of disease and/or are articles (other than food) intended to affect the structure or any function of the human body, rendering them drugs under the Act. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.  


Specifically, the FDA took exception to the following claims:

• “[H]elps erase and repair the ravages of sun damage”
•  “[S]timulates collagen production”
• “BHA penetrates skin to… neutraliz[e] bacteria.”
• “[A]ge-repairing antioxidant that encourages . . . collagen production”
•  “[A]n age-repairing antioxidant that promotes the regeneration of damaged . . . skin”
• “[A]nti-inflammatory”

• “The anti-aging formula speeds healing and increases surface circulation…”
• “[B]IO-A CONCENTRATE helps control acne by reducing inflammation and bacteria production.”
• “Retinol reduces that red inflamed appearance associated with Rosacea and acne.”

•  “[S]timulates collagen formation”
•  “[P]rimary anti-inflammatory”
•  “[E]chinacea – anti-inflammatory”
• “Vitamin C supports … production of collagen.”
• “[P]romotes the regeneration of damaged skin… helps heal wounds …stimulates white blood cells…enhances the immune and lymphatic system”

• “[C]alms inflammation and redness”
•  “[P]roven to stimulate collagen and elastin production, assists natural skin repair that helps heal scar tissue”
• “[H]elps correct the appearance of Rosacea”
• “[H]eals and prevents acne production … allowing foom [sic] for new cell growth.”
• “[M]ildly antibiotic …”
• “Tea Tree – Anitseptic, antifungal and antibacterial”
• “Tocopherol (Vitamin E) is an age-repairing antioxidant that promotes the regeneration of damaged …skin.”
• “Copper Peptide is a…powerful skin regeneration agent that effectively treats acne…while calming irritated and inflamed skin. Copper also stimulates collagen and elastin formation.”

• “[I]ncreases fat metabolism”
• “[W]ake up circulation to help move fat-trapping fluids.”
• “Fatty areas of the body, neck and chin melt away as fat and water are excreted from skin cells. Cellulite starts to disappear…”
• “[A] reduction in cellulite in just two weeks”
• “[E]nhances skin cell’s ability to use oxygen”
• “[A]ssist with fat metabolism”
• “[A]nti-inflammatory and decongestant”
• “[A]ssists with cell absorption”