California's Estheticians: What's the scope?

Esthetician's services in the aesthetic industry are ever rapidly evolving.

Understanding the regulatory landscape is crucial for any aesthetic professional operating in California. The state has specific guidelines that differentiate between cosmetic procedures and medical practices, ensuring the safety and efficacy of treatments provided to clients.

Product Compliance

California enforces strict guidelines on skincare product safety. Products must comply with the California Safe Cosmetics Act, requiring the disclosure of harmful ingredients. This ensures estheticians use safe and effective products. To ensure compliance, review your professional products MSDS for a full list of ingredients, and review them on the California Safe Cosmetics Program (CSCP) Product Database. https://cscpsearch.cdph.ca.gov/search/

Device Compliance

California's Cosmetology laws state

"992. Skin Exfoliation

(a) Only the upper layer of the skin, known as the epidermis, may by any

method or means be removed, and then only for the purpose of improving

the appearance of the skin.

(b) Skin removal techniques and practices that result in destruction of

living tissue beyond the epidermal layer of the skin is prohibited.

may be used for the purpose of skin exfoliation.

(d) All skin exfoliation products must be applied using the manufacturer's

instructions for consumer health and safety."

In terms of treatments commonly performed, this section of California's regulations often is regarded as a murky area for estheticians. Many find themselves wondering "How do I know if my device or product results in the destruction of living tissue beyond the epidermal layer?"

California's Cosmetology state board states in it's industry bulletien - 08/07/2023 that it does "does not approve or regulate equipment or products used in the barbering and beauty industry. Consequently, the Board provides no opinion on the contemplated use of any machine a licensee is considering purchasing."

The board neither regulates nor provides opinions on any machine that a licensee is considering purchasing.

So…How does a licensee determine if the device they own or are considering purchasing falls within their scope?

Step 1: Research the Intended Use

Research the devices "intended use" and marketing terms on the manufacturers website. Look for terms like "improves the appearance of" vs "cures"

If a device or product claim to "cure" acne scars, it might fall under the scope of medicine. It's crucial as well, that in your own marketing of your spa that your website and social media do not make marketing claims that might fall under the practice of medicine. All marketing must remain within the scope of beauty and cosmetic appearance improvement.

Step 2: Lookup the FDA Registration

California's Cosmetology state board clearly states it does not regulate nor provide recommendations on what is or is not "allowed". So who does?

The FDA has a classification system for devices, categorizing them into different classes such as Class I, Class II, and Class III, based on their level of risk and regulatory controls.

When considering the scope of practice, it's important to recognize that the interaction of a device with the skin can be subject to varying interpretations. Therefore, relying on concrete guidelines such as the FDA's classifications ensures compliance with regulatory standards.

According to the FDA, a "Class 1" device is not considered a medical device - and is therefore falling "under" the medical category into the cosmetic category.

However, it's essential to note that not all "Class 1" devices would be considered for cosmetic use. For instance, using a toothbrush, despite its "Class 1" classification, is not advisable for cosmetic purposes due to its intended use. A device must be appropriately classified for use on a client's skin. Using a food-grade cheese grater during pedicures, for example, would violate regulations due to it's intended use.

If a company does not have an FDA device registration - this step is unverifiable. Because Cosmetology state boards cannot regulate equipment, an inspector might see a device with a perceivable risk of damaging the skin beyond the living layers, and issue a code violation. Without the FDA's classification system to verify the device is not medical in nature, and it's intended use is for beautification, a licensee cannot prove their equipment falls within their scope.

Proving your equipment falls within your scope is the licensee's responsibility. It's advisable to only use equipment (and products) from vetted manufacturers that can prove via FDA registration that the devices do not penetrate past the living layers of the skin. Ordering unverifiable equipment from Alibaba, or Amazon, put you at risk during an inspection. All devices used should have a registration, and also provide manufacturers instructions for safe use (MSDS) and include proper sanitation protocols. Lookup your devices manufacturer or device name on the FDA's Database here:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm

Step 3: Prepare your Equipment Evaluation Form

To further ensure compliance, estheticians should prepare an Equipment Evaluation Form, which helps verify that the devices they use are safe and within their professional scope.

Here's what to include in the form:

Equipment Identification:

Name, type, and model number of the equipment.

Intended Use:

Manufacturer's intended use.

Your intended use.

Distributor/Manufacturer Contact Information:

Name, address, contact details.

Registrations/Certifications:

FDA registration number and class.

Copy of the Safety Data Sheet (SDS).

Any relevant safety certifications (such as UL, CSA, or CE).

Liability insurance details from the manufacturer and/or your insurance provider.

Manufacturer's cleaning and disinfection protocols.

Contraindications for equipment use.

Preparing and maintaining this form ensures that estheticians are using compliant and safe equipment, thus minimizing risks during inspections and enhancing client safety. Keep this where your device is stored at your facility in case of an inspection, and print out the manufacturers FDA registration page for good measure.

California's esthetician regulations shape the beauty industry by ensuring high standards for training, product safety, and market compliance. This results in a safer and more reliable experience for consumers and professionals. Exhibitors at trade shows must understand and adhere to these regulations for success in the Californian market. Ensuring compliance with these regulations not only protects clients but also enhances the credibility and professionalism of estheticians.

Not Legal Advice: The information provided by the Alliance, including compliance with state boards and regulations, is for informational purposes only and does not constitute legal advice. We recommend that you consult with a legal professional for specific legal guidance. Crowdsourced Information: The content on this website is crowdsourced from estheticians and industry professionals. While we strive to ensure the accuracy of this information, it is subject to change as new information becomes available and as legal requirements evolve.

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