FDA Warns Cosmetic Companies About Anti-Aging Claims

In 2012 FDA issued warning letters to Avon and Lancôme citing wrinkle reduction, regeneration and anti-aging claims. Over the past twelve months FDA has issued many warning letters to smaller cosmetic companies for making similar drug effect claims.  The letters issued between August 2015 and June 2016 were the result of inspections at the cosmetic manufacturing facilities.  However, in last week of July and the first week of August 2016 FDA issued several warning letters based on visits to cosmetic company websites.

Per FDA regulations cosmetics may be marketed for “cleansing, beautifying, promoting attractiveness, or altering the appearance.”  Many of you will recognize discussions we have had about proposed claims on your cosmetic products in the list of statements below that FDA has characterized as drug claims in those recent warning letters to cosmetic companies.

Effects on Wrinkles and Skin Structure

  • “relaxes facial tension leading to the reduction of facial lines and wrinkles”
  • “Will diminish fine lines and wrinkles, eradicate crow’s feet …”
  • “Improves the firmness and elasticity of skin, removes crow’s feet…”
  • “…enhance the production of elastin and collagen in the skin…”
  • “reduces the depth of wrinkles…by attenuating muscle contraction…”
  •  “strengthens capillaries to minimize discoloration”
  • “…ingredients that can help increase fatty tissue volume to…plum up…”
  • “Special new peptides and additional ingredients can help increase the volume of fatty tissue.”
  • “known to stimulate acetylcholine, thus helping aging skin achieve improved facial contours.”
  • “firming effects are believed to involve the signaling of acetylcholine in the skin.”

Regeneration & Inflammation Claims

  •  “essential oils offer …cellular regeneration…”
  • “EFA’s reduce inflammation and protects from accelerated aging.”
  • “anti-inflammatory, regenerative…”
  • “Supports the synthesis of new skin fibers, boosts cell regeneration…”
  • “Activates the skin receptors stimulating…skin regeneration”
  •  “inhibition of collagenase and hyaluronidase…
  • “skin immune cell macrophage activation…”
  •  “inhibits elastase (protects elastin) …”
  •  “ vegan stem cells…a new way for your skin to build collagen, repair itself and prevent aging.”
  • “This serum will increase skin hydration by inhibiting hyaluronidase…”
  • “support cell communication.”
  • “proven in laboratory studies to stimulate growth in cultures of aged human epidermal stem cells”
  • “…has antioxidant effects”

Skin Whitening Claims

  • “Proven significant whitening activity”
  • “Targets all types of pigmentation concerns: dark spots, age spots, melisma, freckles, and blotchiness and helps to prevent future appearance of pigmentation”
  • “… break down stubborn melanin deposits.”
  • “lighten skin by inhibiting or interrupting the skin’s production of melanin.”

Prevention, Healing & Drug Effect Claims

  • “Heal damaged skin from scars and burns.”
  • “Reduce scar tissue and stimulate the growth of new skin tissue.”
  • “beneficial for many skin conditions such as rosacea, dermatitis, eczema, acne and psoriasis.”
  •  “Beneficial for many skin conditions, including … cracked skin, sun burn, chapped lips…”
  • “Made with organic oils… calming, anti-inflammatory and healing properties.”
  • “helps fade and clear bruises.”
  • “Also helps treat red, irritated areas on the face, spider veins and rosacea…”
  • “…prevents damage to collagen and elastin production…”
  • “will repair the DNA of the skin…”
  • “Effects similar to Botox”
  • “Revitalize your body’s natural abilities to heal itself…”
  • “proven to improve acne…”
  • “helps to protect the skin against damage from UV rays…”
  •  “Soothes and reduces redness and irritation”
  • “Reduces blemish-causing bacteria…”

With FDA’s review of cosmetic claims extending to websites and companies of all sizes, it is time to carefully review your labeling ensure that claims such as those listed above are edited or removed.




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