Aromatherapy: Good Manufacturing Practices

How good manufacturing practice requirements are different

Good manufacturing practice (GMP) is an important factor in assuring that your aromatherapy and cosmetic products are neither adulterated nor misbranded.

However, no regulations set forth specific Good Manufacturing Practice requirements for cosmetics. Do you know what this means?

It simply means, everything in the cosmetic aromatherapy manufacturing is allowed. No wonder that you find about five carcinogens alone in lipsticks! Let alone the known carcinogens propylene glycol and sodium lauryl sulfate in your bubble bath and shampoo. Did you read the labels lately? Your toothpaste has a Warning Label: "Contact the Poison Control Center immediately!"

Propylene glycol is a substance that is smooth like velvet (commonly used as garage floor cleaner and engine degreaser). It is often mixed with essential oils to give the oil a luxurious texture.

In addition, there are companies out there that have made it their mission to manufacture a synthetic oil for every pure essential oil distilled. You may well guess that synthetic oils are considerable cheaper. Aromatherapy companies that solely operate for their profits with no consideration of people's wellbeing use of course synthetic oils.

In contrast to cosmetic and aromatherapy product regulations, the law requires strict adherence to GMP requirements for drugs, and there are regulations specifying minimum current GMP requirements for drugs [Title 21 of the Code of Federal Regulations (CFR), parts 210 and 211]. Failure to follow GMP requirements causes a drug to be adulterated [FD&C Act, sec. 501(a)(2)(B)].

How registration requirements are different
FDA maintains the Voluntary Cosmetic Registration Program, or VCRP, for cosmetic establishments and formulations [21 CFR 710 and 720]. As its name indicates, this program is voluntary. That's right - voluntary. In contrast, it is mandatory for drug firms to register their establishments and list their drug products with FDA [FD&C Act, sec. 510; 21 CFR 207].

How labeling requirements are different
A cosmetic product must be labeled according to cosmetic labeling regulations. See the Cosmetic Labeling Manual for guidance on cosmetic labeling. OTC drugs must be labeled according to OTC drug regulations, including the "Drug Facts" labeling, as described in 21 CFR 201.63. Combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling. For example, the drug ingredients must be listed alphabetically as "Active Ingredients," followed by cosmetic ingredients, listed in order of predominance as "Inactive Ingredients."


Maria Schasteen is the owner of Aroma-essence.com and publisher of the Aromatherapy Tip of the Week.