FDA Regulations for Aromatherapy

Because essential oils and aromatherapy don’t have their own regulatory definitions, there is no simple, universal approach to safety. Essential oils can be found in products as diverse as beauty products, therapeutic oils, and lotions, so the FDA regulates them according to their purpose.


If that delicious lavender oil is merely there to add scent to a moisturizer, it’s treated as a cosmetic. It needn’t comply with any regulations, but if safety problems arise after it hits the market, the FDA will take action. Similarly, if labelling is incomplete or misleading, they will exercise their authority. Healthy Solutions takes its skincare seriously, using analytical chemists, strict quality control methods, and pure ingredients to assure safety.


Any product that makes therapeutic claims is treated as a drug, even though ingredients are taken from common flowers and plants. Aromatherapy oils that make therapeutic claims must undergo a thorough approval process, proving their efficacy in a series of phased trials. This is an expensive process and requires specialized manufacturing that doesn’t allow contamination by other ingredients.

Cosmetics and Drugs

If your cosmetic product is marketed as therapeutic, it’s regulated as a cosmetic and a drug. A scented oil that claims it soothes stiff muscles or eliminates headaches must comply with the same regulations that medications do.

Other Products Using Essential Oils

Candles and air fresheners aren’t regulated by the FDA. The Consumer Product Safety Commission is responsible for keeping the industry safe and honest.

Phased trials are often too expensive for even mid-sized businesses, so most aromatherapy retailers are careful about marketing their products as cosmetics and scents instead of drugs. Therapeutic claims on such products must be quashed, not only from packaging, but websites and advertising, too.

However you choose to classify your aromatherapy products, Healthy Solutions has the expertise and experience to guide ethical labeling, prevent contamination, and keep your product claims in compliance.