FDA Warning Letter: Needling Device Exceeds Dermabrasion Exemption

On January 9, 2015, the FDA issued a warning letter to Derma Pen, LLC, claiming the company’s micro-needle dermabrasion device is an adulterated and misbranded Class 1 medical device and challenging the marketing of the company’s line of “cosmeceuticals” as misbranded drugs.

FDA asserts that the automated micro-needling device, which uses a stamping action to create micro-injuries to the skin, is not exempt from premarket approval under  21 CFR 878.4820 (Dermabrasion Brush, Powered).  Exempt powered Dermabrasion brushes have abrasion substrates such as brushes, rasps or burrs intended to abrade and remove layers of the skin via shear force.  The Dermapen, however, achieves its clinical effect through the creation of many small puncture wounds in the skin.  According to the FDA, safety concerns regarding the safe ranges of needle lengths, penetration depths, and speeds of the device are unknown–including concerns regarding the potential for damage to blood vessels and nerves.

Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), [21 U.S.C. § 321(h)], these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or function of the body of man.  Such devices must have an approved application for premarket approval (PMA) or an approved application for an investigational device exemption, and the FDA must be notified of the manufacturer’s intent to introduce the device into commercial distribution prior to entering the market.

As a result, the FDA requested that Derma Pen, LLC cease commercial distribution of the device.

FDA’s warning letter, also noted several products referenced in Derma Pen’s promotional materials as “cosmeceuticals.” “Cosmeceutical” is an industry coined term often used for cosmetics which are also intended to provide therapeutic benefits.  Under the FD&C Act, however, there is no such category.  Instead, a product may be a drug, a cosmetic, or a combination of both, but as the FDA pointed out, “the term ‘cosmeceutical’ has no meaning under the law.”

Based on Derma Pen’s promotional materials, the FDA identified several products as meeting the definition of a drug, rather than a “cosmetic,” because the claims associated with the products demonstrate the products are also intended to cure, mitigate, treat, or prevent disease, or are intended to affect the structure or function of the body.

Similar to claims I previously discussed here, the FDA identified keys phrases in the promotional materials:

  • “…increases moisture binding and hydration content within the dermis layer of the skin”
  • “…heals the skin”
  • “Stimulates immune defense, fibroblast growth and collagen synthesis.”
  • “…encourages collagen production, reverses sun spots”

Notably, to be legally marketed, products that meet the definition of a drug, regardless of whether they are also cosmetics, must comply with all applicable drug provisions of the FD&C Act and its implementing regulations.

Take awayavoid the buzz words. If a product’s promotional materials include references to the stimulation of cells, increasing the production of collagen, healing, reversal of cell damage, etc., then the product will likely meet the definition of a drug. An ounce of prevention goes a long way, i.e., have marketing & promotional materials reviewed by legal before going to market/print. For further discussion see my prior post claims regarding unintended drug claims here.

(*The image associated with this post is not the offending needling device.)

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