Chiming in - help on labeling
Thought I would chime in here and maybe help clear up a few points ... (trying to answer the various questions posted by different people)
First, when it comes to labeling and regulations, you have to remember that it is determined by what CLAIMS are made about the product.
For example, a soap can be:
- a SOAP if the only claim is that it cleans (and it's a "true soap" made with lye and oil)
- a COSMETIC, if there are claims that it promotes attractiveness or makes one more beautiful
- a DRUG, if there is a claim that it treats, cures, mitigates a disease or physical condition
- an INSECTICIDE, if there is a claim that it repels bugs
- a FOOD, if it is intended to be eaten (not really applicable to soap, but there have been "edible cosmetics" --- which are treated as food.
The FDA defines the LABEL as the information that is ON the product. They define LABELING as the information that goes WITH a product (as in a brochure with the product, or information on a website about the product). The FDA regulates LABELS and LABELING of foods, drugs and cosmetics.
The FDA has been cracking down lately on drug claims made for "cosmetic" items. In recent warning letters, they have cited information in brochures, on websites (including in explanations of ingredients and testimonials), facebook pages, and even meta data on a site's website. See my blog post:
FDA Cracking Down on Cosmetic Product Claims.
Note that making a claim about an INGREDIENT in a product is considered to be making a claim about the product itself. So if the product contains tea tree oil, and you say that tea tree oil is "known to be an anti-fungal" - then you're considered to be making the claim that the product itself is anti-fungal (and so an "unapproved drug").
ADVERTISING, which is done separately from the product itself (ie TV, magazine, radio), is covered by a different federal agency.
ALL PRODUCTS require four things on the label:
- Name of the product
- Identity (what it is)
- Net Weight
- Name and address of responsible party.
Soap (if it's "true soap" and only claims to clean) isn't regulated by the FDA, but it still requires those 4 things on the label. In that case, it's regulated by the Fair Trade Commission.
Cosmetics require those 4 items on the label, AND the ingredient list.
Drugs require those 4 items, plus information about the active ingredients and a few other things. Drug
Foods require those 4 items, plus ingredients, plus nutritional facts.
There are two types of drugs ... drugs that require pre-approval from the FDA (usually prescription drugs that are "invented" by a company, tested and then proven to work ... and then approved by the FDA) and Over The Counter (OTC) drugs, that contain ingredients that are
already approved for certain uses.
Even though, for example, tea tree oil is known to be anti-fungal, but it's not on the FDA approved list for OTC drugs. There is a list of the ingredients that are approved for different uses, and each one has clearly defined usage levels and what claims can be made about it. Those are called "Monographs". You can't just add the "Active Ingredient" to the label and put it in the right form - it has to have a monograph that is followed.
Drug manufacturers (including OTC drugs) must be registered with the FDA and inspected, and are required to follow good manufacturing practices that are outlined in regulations (and are VERY detailed). So even if you make an anti-bacterial product containing tryclosan and do it exactly per the monograph - you would then be a drug manufacturer and have to follow all THOSE regulations as well.
Food supplements, which are also regulated by the FDA, have some allowances for making nutritional claims that can be tied to healing or curing conditions caused by lack of a substance. These allowances are very specific and for use only with nutritional supplements. If you've ever seen that disclaimer, "This statement has not been evaluated by the Food and Drug Administration..." - it's part of what they are allowed to do. See my blog post on
Using an FDA Disclaimer on Cosmetics for more about that.
I hope this helps a bit. If you have any questions about any of these points, please comment and I will try to answer. Or you can email me. There's also more information on my blog (
blog.mariegale.com) or my website (
www.mariegale.com).
Note that I'm getting ready for the Handcrafted Soap & Cosmetic Guild annual conference in Raleigh in a few weeks, so I may not be super-fast in responding.
Marie Gale
