In 2017, the global cosmetics industry was valued at $532.43 billion, and is projected to grow to $805.61 billion by 2023.1 In a sector with such substantial growth potential, companies are exploring ways to distinguish their products from their competitors and meet consumers’ needs. As the consumer trend to seek “natural” products continues to grow, primarily due to their unfounded assumption of safety, products with “natural” labels are virtually everywhere and cosmetic products are following the trend to be “more natural” than competing products. For example, companies are now marketing “wild” cosmetics, hoping to position “wild” products as superior to their “natural” equivalent, but “wild” cosmetics are not inherently safe and must be evaluated for safety.
“WILD” COSMETICS
Much like “natural”, the term “wild” is not defined by the FDA, allowing for variations in the definition of the term. Based on the latest marketing trends, “wild” may include ingredients derived from botanicals grown in environments that have not been manipulated by humans, such as a remote rainforest or temperate deciduous forest. In contrast, a “natural” botanical may be harvested from a greenhouse, garden, or farm. The erroneous belief is that “wild” products and ingredients are inherently safe. In reality, the source material does not solely dictate an ingredient’s safety profile, instead the constituents (and their concentrations) and conditions of use (e.g., target population, dose, or frequency of use) of the ingredient all contribute to its safe use.
For example, red henna, which is derived from Lawsonia inermis grown in Africa and Asia, is commonly used to dye hair, skin, and nails.1 When used to dye the skin of adults and some children only occasional reports of contact dermatitis have occurred. However, children with glucose-6-phosphate dehydrogenase deficiency (affecting approximately 400 million people worldwide) have experienced severe adverse effects, potentially due to the naturally-occurring constituent, lawsone (2-hydroxy-1,4-napthoquinone).3 Further, it is becoming increasingly popular to add p-phenylenediamine (PPD) (dye) to red henna to create black henna, “but use of black henna is potentially harmful”,2 because when black henna is applied to the skin, reported adverse effects include, allergic contact dermatitis consisting of red rashes, itchiness, blisters, and sensitivity.2,4 These adverse effects highlight the importance of evaluating cosmetics for safety, despite the source(s) of the ingredients.
REGULATORY FRAMEWORK
There is not an FDA pre-approval process1 for cosmetics2 in the US, but the sale of cosmetics is governed by the provisions of the Federal Food, Drug and Cosmetic Act (FFDCA) (21 U.S.C. 9), and the regulations published in the Code of Federal Regulations (CFR) issued under its authority. Per FFDCA, it is strictly prohibited to introduce an adulterated or misbranded cosmetic into interstate commerce. A cosmetic would be considered adulterated if it contains a poisonous or deleterious substance3 that may injure a consumer if used as directed on the label or according to customary use.4 Under 21 CFR §740.10, before a cosmetic product may be marketed, the safety of the cosmetic and the ingredients must be “adequately substantiated for safety”. Further, the label must contain a warning statement if the product is hazardous when misused (21 CFR §740 Subpart A). As such, cosmetics are regulated products under the FDA’s jurisdiction, and regardless of the source material(s), must be evaluated for safety when used according to the directions on the label or customary use (FFDCA Section 601(a)).
The FDA also has a voluntary registration for cosmetics sold in the US, and requests that owners and operators of manufacturing and packaging facilities register establishments 30 days prior to commencing operations (21 CFR §710). In addition, manufacturers, packers, and distributors are requested to file cosmetic product ingredient composition statements, although ingredients may be labeled as “confidential” and are not be viewable in registration documents (21 CFR §720).
CONCLUSION
As companies attempt to differentiate their products from competitors’ products, it is critically important that the safe use of cosmetics containing botanicals (or “wild” ingredients) is not assumed based on the source(s) of the ingredients. All cosmetics and ingredients must be assessed for safe use under the conditions of use specified on the label or according to customary use. Burdock Group has extensive experience in the regulatory and safety of cosmetics. If your company has questions regarding the appropriate safety evaluations or regulations, please reach out to us, as we would be happy to assist.
Orbis Research (2018) Global Cosmetics Products Market-Analysis of Growth, Trends and Forecasts (2018-2023). Site last accessed February 22, 2019.
FDA (2013) Temporary Tattoos May Put You at Risk. Site last accessed February 25, 2019
de Groot, A.C. 2013. Side-effects of henna and semi-permanent ‘black henna’ tattoos: a full review. Contact Dermatitis, 69(1): 1-25.
Penfili, E., Esposito, S., and Di Cara, G. 2017. Temporary black henna tattoos and sensitization to para-phenylenedyamine (PPD): two paediatric case reports and a review of the literature. Int J Environ Res Public Health, 14(4): 421.
Color additives are an exception, as most color additives require pre-market approval
Per the FFDCA, cosmetics are, “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” (FFDCA §201(i)).
Under 21 CFR §700 Subpart B, specific ingredients are strictly prohibited for use in cosmetics.
Products containing “filthy, putrid, or decomposed substance” or “prepared, packed, or held under insanitary conditions whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health” are also unlawful. Color additives must be used according to the approved intended use. And, the containers for cosmetics must not be composed of any substance that is poisonous or deleterious which may be injurious to health.