Tips for personal care, cosmetic and dietary supplement product start-up companies
Licensing regulation and labeling requirements for personal care, cosmetic, and dietary supplement products is explored.
Some personal care products are defined as Cosmetics. The U.S. Food and Drug Administration’s (FDA) Small Businesses & Homemade Cosmetics: Fact Sheet states that a product is a cosmetic if it is intended for uses such as cleansing the human body, making a person more attractive or changing a person’s appearance. Some examples FDA gives of such products on the fact sheet are makeup, moisturizers, hair dyes, hair permanent waves, hair straighteners, hair removers, perfumes and colognes, nail care products and essential oils labeled and marketed as fragrances.
The fact sheet notes that cosmetic products and ingredients, with the exception of color additives, are regulated by the FDA and do require FDA or state approval before being sold. However, the fact sheet encourages companies to register their business and file their product formulations with the FDA Voluntary Cosmetic Registration Program (VCRP). For more information, see the following FDA guidance documents: Cosmetic Information Fact Sheet and Resources for Industry on Cosmetics.
In addition, the fact sheet is clear that it is not against the law to manufacture cosmetics in your home, although it’s the responsibility of the manufacturer to make products in an environment that will not cause them to become adulterated. FDA does not have regulations specifying good manufacturing practices (GMP) for cosmetics nor do they need to inspect your product or process before the product is sold. However, the fact sheet gives the Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist, which is referenced as a list of factors an FDA investigator would look at during an inspection if there is a report of a problem with the product. In addition, assigning an appropriate shelf life is the manufacturers responsibility in making sure the product is safe for consumers, per FDA.
A cosmetic product must be labeled according to cosmetic labeling regulations. See the Cosmetics Labeling Guide, the Cosmetic Labeling Regulations and the Cosmetic Labeling Manual that includes information on cosmetic labeling.
The FDA defines drugs as products that are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease and intended to affect the structure or any other function of the body or other animals". FDA’s examples of common personal care items that are classified as drugs are lip balms, essential oils when marketed as aromatherapy, diaper ointments, mouthwashes marketed with therapeutic claims, antiperspirants and treatments for dandruff or acne.
The term cosmeceutical is not a term recognized as a category by FDA. However, when a product normally classified as a cosmetic makes claims on what it can do to mitigate, treat or prevent something, it falls into a combination of a cosmetic and a drug. This combination means the product must meet the requirements for both cosmetics and drugs, per the FDA. Examples of common personal care items that fall in this category include moisturizers with sunscreen, make-up with sunscreen, shampoo that markets as a dandruff treatment and cream marketed as an anti-wrinkling agent.
Drug products must either receive pre-market approval by FDA through the New Drug Application (NDA) process or conform to a monograph for a particular drug category, as established by FDA's Over-the-Counter (OTC) Drug Review. Companies will need to register their firm and list their products with FDA. For more information, contact FDA’s Center for Drug Evaluation and Research (CDER), Division of Drug Information, Small Business Assistance, at CDERSmallBusiness@fda.hhs.gov.
Under the FDA, homeopathic products are subject to the same requirements related to approval, adulteration and mis-branding as other drug products. There are currently no homeopathic products approved by FDA. Per the FDA Fragrances in Cosmetics, if an aromatherapy product is intended to treat or prevent disease, or to affect the structure or function of the body, it’s a drug.
The FDA guidelines on labeling give general labeling needs along with defined needs for OTC, prescription drugs and several other factors.
Unlike drugs, dietary supplements are not intended to treat, diagnose, prevent or cure diseases. Per the FDA, dietary supplements include such ingredients as: vitamins, minerals, herbs, amino acids and enzymes. Dietary supplements are commonly marketed in the following forms per FDA: tablets, capsules, soft gels, gel caps, powders and liquids. These products are regulated by the FDA and do require FDA or state approval before they go to market. Per FDA, manufacturers need to register themselves pursuant to the Bioterrorism Act with FDA before producing or selling supplements. An information page by FDA covers a variety of topics on supplements.
Since supplements are not intended to treat, diagnose, prevent, or cure diseases, their labeling shouldn’t make health claims, such as “reduces pain” or “treats heart disease.” Claims like these can only legitimately be made for drugs, not dietary supplements. Supplements are to follow the FDA Guidelines for labeling and addresses the following: identify statement, net quantity, nutrition label, ingredient label and more.
To be a soap, according to the FDA’s Frequently Asked Questions about Soap, the bulk of the product consists of an alkali salt of fatty acids, the product's detergent properties are due to the alkali-fatty acid compounds, and the product is labeled, sold and represented solely as soap. Per the FDA, “to be regulated as soap, it must be labeled and marketed only for use as a soap”. Soap, as defined above, is regulated by the Consumer Product Safety Commission (CPSC), not by FDA. See their Soap Business Guidance for more information.
If the product doesn’t meet the soap definition above, it is regulated by FDA as cosmetic, drug or a combination of both based on labeling claims and intended use. If it is intended for purposes such as moisturizing the skin, making the user smell nice or deodorizing the user’s body, it’s a cosmetic per the FDA. Or, as the CPSC notes, if the product is intended to treat or prevent disease, such as by killing germs, or treating skin conditions, such as acne or eczema, it’s a drug and will be regulated as such by the FDA.
True soaps as defined above with no colorants or hazardous substances have no specific CPSC-enforced regulations regarding the labeling of soap ingredients. Regardless of whether it is regulated as a soap, cosmetic or drug, the word soap on the label is still allowed. Consumer interest in labeling to identify ingredients, the company name and location of processing, as well as marketing drives labeling with this product.
The U.S. Food and Drug Administration’s (FDA) web page called Small Businesses & Homemade Cosmetics: Fact Sheet, provides guidance on the use of organic and bio-based claims on a label, noting that a company would need to meet United States Department of Agriculture (USDA) standards. See the USDA National Organic Program and the USDA Certified BioBased Product for the requirements to use such terms.
The MSU Product Center and MSU Extension is no longer taking on new clients with products that are cosmetics, drugs, dietary supplements and/or soaps. The center recommends that individuals or companies wishing to produce such products seek assistance from an attorney who has experience in assisting companies in these areas.
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