Medical-Grade Myths
There are many misconceptions regarding the regulation of skin care products and services. Creative marketing terms only further the confusion.
In the United States, the licensing board of each individual state regulates the scope of practice of skin care professionals. Those professionals include, but are not limited to, aestheticians, nurses, and physicians. Depending on state regulations, performing some types of skin care services may only be authorized to doctors or aestheticians working in a medical spa under a doctor’s supervision. Examples of those services are higher-strength chemical peels and lasers. In short, aestheticians, and often nurses, are limited in their scope of practice while physicians are not limited at all. In the cases where a desired service is out of the professional’s scope of practice, they may choose to work under a doctor’s supervision and give up some of their income to compensate the medical doctor, or they may be on the doctor’s payroll as an employee. However, the term medical aesthetician is not regulated either, and there are no medical aesthetician licenses.
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MISLEADING MARKETING
The terms medical skin care or medical-grade skin care are neither used nor regulated by the State Boards of Cosmetology or Medicine and the FDA. They are marketing terms meant to convey to clients that the services are supervised by a doctor, which can contribute to clients feeling safer or that the skin care services will be better or more effective. Besides reassuring messages, the term may signal pain and downtime after services and that the medical setting may not be as relaxing and attractive as a spa’s. Another underlying message is that skin care in a nonmedical facility might be less effective, although with no pain or side effects.
DEVICES
Devices are regulated by the Food and Drug Administration (FDA). There are three classes of devices categorized by the FDA according to the risk they pose. Class I includes devices with the lowest risk, and class III includes those with the greatest risk. All three classes of devices are subject to general controls that are the baseline requirements of the Food, Drug and Cosmetic (FD&C) Act. A class I device may be a lymphatic drainage device while a laser may be in class II or III depending on the type of laser. Who is allowed to use a particular device is determined by State Licensing Boards, not by the FDA or the class of the device; the rules differ greatly between states. On the other hand, some devices are only for use by medical professionals because they perform medical or surgical treatments.
Lobbies working on behalf of associations, such as the American Medical Association (AMA), cite public protection to push hard against skin care professionals using certain devices or products. They can only be used by physicians or under the supervision of physicians after the lobbies succeed at changing the laws or rules.
PRODUCTS
Production facilities manufacturing cosmetics or skin care products for retail or professional use are regulated by the FDA and frequently inspected by FDA agents. The regulations and record keeping are stringent; the rules apply to skin care or cosmetics manufacturing and over-the-counter drugs, such as sunscreens.
Over-the-counter products have a few extra requirements. The regulations are the same for products sold or used by skin care professionals, including doctors. Claims on some brands’ websites or on social media that skin care products offered in medical settings are subject to more scrutiny for quality or purity, or have higher percentages of actives, are untrue. There are different qualities of ingredients a manufacturer can choose from, cosmetic-grade or pharmaceutical-grade, but the FDA does not impose either.
THE FDA
The regulations for skin care products or cosmetics are the same regardless of where they are being sold; the FDA does not regulate where brands can sell their products. Brands decide where they sell in line with their business model and marketing. They can sell to the public directly (B2C) or B2B to retail stores, spas and aestheticians, wellness centers, the hospitality industry, or medical professionals, and sometimes to all of the above. The FDA is responsible for protecting the public’s health by regulating medications, medical devices, tobacco products, human and animal food, cosmetics, and radiation-emitting electronics.
The FDA requires cosmetics to have an ingredient declaration, or a list of all the product’s ingredients under the Fair Packaging and Labeling Act (FPLA). Ingredients must be listed on retail packaging in descending order of percentage; in other words, the higher percentage is listed first.
PROFESSIONAL PRODUCTS
Professional-only or backbar products, such as peels, may come in different strengths. The brand or manufacturer may choose to only sell higher-strength peels to medical professionals for a number of reasons, such as safety, liability, and professional training. Their insurance companies may impose restrictions as to whom to sell to. Practitioners, such as aestheticians, may have restrictions and guidelines by their liability insurance, too. Those barriers are independent from a state’s licensing board’s rules.
A company or brand can label a skin care product maximum strength, clinical strength, medical strength, or doctor’s formula for any reason it sees fit as the terms are not regulated and do not guarantee that the product is stronger or more concentrated in actives than others on the market. Percentages of ingredients are not disclosed; the ingredient list is not required to be disclosed for professional products. Over-the-counter products must list the percentages of actives per FDA rules.
There are many gray areas when it comes to skin care professionals’ state regulations and scope of practice. With these clarifications, professionals and clients alike can decipher what is best for them and what is just marketing or social media noise.
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Catherine Atzen is an innovator and trendsetter in the spa and wellness industry and was recognized by DERMASCOPE Magazine as an AIA Legend for her lifetime contributions to the field. She is credited with coining the term “day spa” and setting industry standards for high-end, clean, and effective skin care. Atzen has trained over 20,000 professionals worldwide and has had 225 articles published. She founded ATZEN which has more recently became ATZEN Superior to Organic Skin Care when she took the line to new heights by incorporating the best organic ingredients with naturally derived high-performance cosmeceuticals to truly transform one’s skin.
