It is the intended use of a product that determines what it is. Oddly enough, it can be the exact same product formulation, but it could be classed as different types of products depending on what you say is its intended use.
What is it?
- If the intended use is… To cleanse and it is marketed only as “soap”
It is … Soap - If the intended use is… To cleanse and/or improve appearance (e.g., moisturize)
It is a … Cosmetic - If the intended use is… To treat, cure, mitigate or prevent disease (e.g., “cure acne” or “antiseptic”)
It is a … Drug - If the intended use is… To repel bugs (e.g., “bug away” or “flea shampoo”)
It is an … Insect Repellent - If the intended use is… To be eaten as a food, “is edible”
It is a … Food - If the intended use is… To be ingested as an aid to nutrition (but is not a food)
It is a … Nutritional Supplement
This is a very important concept to understand: the intended use is the determining factor for what the product IS. Seems crazy and backward (and pretty much is crazy and backward) but that is how you determine how to label your product and what the applicable regulations are.
Soap is the worst possible offender—and the most confusing—because the same bar of soap can be so many different things! Take a bar of cold processed soap that contains lavender, tea tree and citronella essential oil; it could be a soap, a cosmetic, a drug, or an insect repellent, just because of what you say it will do (clean, mosturize, cure acne, or repel insects, for example).
Claims
You’ll often hear people talk about “making claims” for a product. The claims are what you say the product can do, which is what determines the intended use.
Mind you, these are not just the claims that are made on the product itself; it is also all the claims and statements you make about the product in brochures, on display signs, in website product descriptions, even in Facebook posts or Twitter tweets about the product or customer testimonials.
Not only that, the claims made for an ingredient can (and frequently do) help decide the intended use of the product.
The bottom line is that the intended use is what the consumer thinks it is. And the consumer determines that based on the claims that you have made for the product and its ingredients. If you claim that the product “reduces the itchiness of poison oak” or is a “poison oak soap,” then the consumer thinks the intended use is to “treat poison oak” or “mitigate the effects of poison oak,” and so the product is now a drug. If your product contains lavender and you say that “lavender oil is known to soothe itchy skin,” then the consumer thinks the product is intended to “treat itchy skin” (otherwise why would you have mentioned it?) and so the product is a drug.
Why is it So Important?
WHAT the product is (based on the intended use) determines not only the agency responsible for oversight and regulation of the product, but also which laws and regulations apply.
Soap
Soap (provided it is “the alkali salt of fatty acids,” is identified as “soap” and only claims to clean) is regulated for SAFETY by the Consumer Product Safety Commission, and for LABELING by the FTC. No registration of facilities or products is required.
Label: The label requires identity of product (soap), net weight and name and address of manufacturer or distributor. Ingredients are not required.
GMP: The product must be safe, but good manufacturing practices are not required in the regulations.
Cosmetics
Cosmetics are regulated by the FDA. Soap is considered a cosmetic unless it meets the exact definition (given above). No registration of facilities or products is required at the federal level. Some states require facility and/or product registration before products may be made or sold.
Label: Label requires the identity, net weight, name and address, and ingredient declaration.
GMP: The product must be safe, but good manufacturing practices are not required in the regulations. However, the FDA’s GMP Inspection Checklist is used as a guideline for determining whether a product is likely to become unsafe (adulterated or misbranded), so if your GMP isn’t reasonably in place, then the product will be considered “likely to be adulterated or misbranded” (read “unsafe”).
Additional: Color additives must be on the list of color additives approved for cosmetics. Some products (such as bubble bath, sunless tanning products, feminine hygiene products, for example) require mandatory warning labels.
Drugs
Drugs are regulated by the FDA and most states also have regulations. Over-the-Counter drugs must meet specific requirements to contain ingredients which are known to meet the intended use of the OTC product (called “OTC drug monographs”). Prescription drugs must be fully tested and approved by the FDA prior to marketing or sale. Drug manufacturing facilities must be registered, inspected, and approved by the FDA (and possibly at a state level as well).
Label: Label requires the identity, net weight, name and address. Ingredient declaration is required and must include the percentage of active ingredient(s) and all inactive ingredients. There are additional requirements for what may be said on the label (marketing text), what claims may be made, the inclusiveness of directions for safe use, and any necessary warnings and how they must be presented.
GMP: Good manufacturing standards are required in regulations and are a prerequisite for manufacturing approval.
Additional: There are substantial other regulations and laws pertaining to the manufacture and sale of any type of drugs.
Insect Repellents
Insect repellents are regulated by the Environmental Protection Agency and most states also have regulations. All insecticides must be fully tested and approved by the FDA prior to marketing or sale. There is a small window of exemption for insecticides using “safe” ingredients (such as citronella) which don’t need prior approval by the EPA. State regulations may vary, however.
Label: Label requires the identity, net weight, name and address. Ingredient declaration is required and must include the percentage of active ingredient(s) and all inactive ingredients. There are additional requirements for what may be said on the label (marketing text), what claims may be made, the inclusiveness of directions for safe use and any necessary warnings and how they must be presented.
Food & Nutritional Supplements
Manufacture of food and nutritional supplements is regulated by the FDA at the federal level and by states at a local level. Food manufacturing facilities require registration, inspection, and approval.
Label: Label requires the identity, net weight, name and address, and ingredient declaration, as well as nutritional information and various other things.
GMP: Good manufacturing practices are required in regulations and are a prerequisite for manufacturing approval.
Additional: There are many, many regulations covering food and nutritional supplement manufacturing and marketing. Before manufacturing any type of edible or ingestible product, be sure you know what local, state, and federal regulations apply.
Summary
When you create a handcrafted soap or cosmetic product, always be aware of the intended use you envision for the product. It is your decision and vision that will ultimately determine where your product falls in the regulatory scheme of things and what you need to do to ensure your product and actions are legal.
In other words…
Know before you go!
Shameless plug!
Besides labeling, there are many other laws and regulations that apply to handcrafters. To find out which ones apply to you and how to comply with them, buy my book and keep it handy!
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