By Benjamin L. England, JD
“Microneedling is a classic example of industry and technology getting ahead of the U.S. Food and Drug Administration (FDA), which happens quite frequently in industries with a high rate of entrepreneurial activity. Microdermabrasion products, such as rollers and stamps, have become some of the most popular treatments offered by medical aesthetic facilities and spas, because they offer the patient more youthful-looking, unblemished skin.
Many companies selling microneedling devices register their manufacturing and importing facilities with the FDA, and then list the devices as Class 1 dermabrasion accessory devices, which, in the vast majority of cases, is an incorrect device listing. Because the FDA does not review device listings–and device listing by a company does not mean the device is legal–many of these companies then claim their microneedling devices are “FDA approved.” That is a false statement every time and in every instance it is made, no matter what company makes it. The FDA has never approved any microneedling devices.
Many companies claim their devices should be used with various topical cosmeceuticals, such as ointments, creams, lotions and serums, to assist the topicals in penetrating the deeper layers of the skin. Such devices are regulated not only as medical devices, but also as drug delivery systems and, depending upon the marketing claims used, the ointments, creams, lotions and serums most likely are unapproved new drugs.
The question is whether FDA approval is required. The answer depends upon the device design, its effect on the skin and the claims used to market the device. There is great variation in microneedling products, including:
- Length of needles;
- Format (roller or stamp); and
- Application (electronic, manual or mechanical).
The devices are frequently used alone, but are often marketed as more effective when used with topical products.
FDA regulates needling devices: fact
The FDA’s authority to regulate a product as a medical device depends on whether the product is intended to affect the structure/function of the body or to be used for therapeutic reasons. Intended use is an objective inquiry, not a subjective one, and it is determined by examining the labeling, design, function and marketing for the device.
Based upon FDA Imports direct contact with the Center for Devices and Radiological Health (CDRH) at the FDA, it does not regulate microneedling devices when the needles are short enough to not puncture past the outer (dead) layer of the skin, and there are no offensive claims about the product, such as those regarding affecting the structure/function of the body. The FDA has determined that needle length should be no greater than 0.3 mm in length.
However, the FDA does regulate microneedling devices that have needles that will puncture the skin past the outer layer; that claim to affect the structure/function of the body; are for a therapeutic use; or are intended to be used as a delivery mechanism for topical cosmeceuticals.
The FDA has approved needling devices: fiction
The FDA has not “approved” any needling device. The firms that claim FDA’s approval cite the fact that they have registered the device with FDA. Registering a manufacturing facility and listing a device simply requires paying a fee and submitting a form to FDA. The FDA does not review the registration or listing to make sure it is correct, and registration does not indicate FDA approval. It only means a company knows how to file paperwork. Claims that a needling device is FDA approved are false claims, as a matter of law, and are subject to enforcement action by FDA, FTC, state regulators and self-regulatory bodies, such as the National Advertising Division of the Better Business Bureau.
FDA permits marketing of needling devices as FDA-regulated medical devices: fiction
Though dermabrasion devices may be marketed as medical devices, the FDA does not permit companies to market needling microdermabrasion products as medical devices. In the FDA’s opinion, needling microdermabrasion devices have a different technology, which presents new questions for safety and effectiveness. Thus, to be legally marketed as a medical device, the specific product must first undergo an FDA review and clearance, under the direct to de novo review process. The Pre-Market Notification process (known as the 510(k) clearance) is generally not applicable because there are no predicate devices. Thus far, no one has obtained the requisite clearance from the FDA.
Admittedly there are firms marketing needling products as FDA-regulated medical devices. This is not a case of FDA permitting the sale; it’s rather an issue of FDA’s priorities in enforcing its interpretation of the marketing requirements. Just like not every car that is speeding gets a ticket, not every non-compliant marketing strategy gets FDA enforcement attention … yet.” – Benjamin L. England, Esq. Founder and CEO, Benjamin L. England & Associates, LLC, & FDAImports.com, LLC
Benjamin L. England, Esq.
Mr. England routinely represents domestic and foreign companies of all sizes, assisting them in identifying FDA, USDA, FTC, EPA, and state requirements. His representation enables his clients to better understand and fully comply with federal and state requirements, and thereby reduce the risk of regulatory interference with products being imported, exported, or distributed in interstate commerce.