FDA Labeling Requirements
The MOMENT you stray away from soap, your product is considered a "cosmetic." Cosmetics have strict labeling requirements that are mandated by the FDA. While the FDA does not actually actively police small company labels, the laws have been set in place for YOUR protection. All companies have stumbled a bit to get to 100% compliance with these rules. I, myself, still have rogue labels here and there missing "directions."
- Label must cover at least 40% of the container (excluding top and bottom)
- Product name (can be fanciful, but then must also include a common name- like “sugar scrub”)
- Net quantity of contents (weight excluding container)
- Name and place of business
- Directions for safe use (if product can be misused)
- Ingredient font may not measure less than 1/16 inch in height
- ALL Ingredients are listed in INCI* name in descending order
- Exceptions to the INCI rule are ingredients that make up less than 1% of the total formula, fragrance, flavoring, and colorants. (You still need to SAY colorant, fragrance, preservative, etc., though.)
*INCI stands for International Nomenclature of Cosmetic Ingredients. At the time of this blog writing, in the USA, it is still permissible to use more common names (CTFA editions 2-11) of ingredients on labels. HOWEVER, if a company wants to ship internationally- they need to use INCI codes. For an interesting summary of this topic, check out LotionCrafter's site.
But the point I am trying to make with this post is that you want to know that a company is AWARE of these regulations and working diligently to comply with them. It's simply the right thing to do. Consider what it could mean if a company's label is completely ignoring the FDA.
Do they have any IDEA that cosmetics have rules? If not (to be quite blunt), what business do they have making your skincare products? FDA labeling requirements are no secret and widely discussed and referenced in the industry. A person would have to literally wake up and start both a hobby and a business on the same morning. (Which is also scary, isn't it?)
Do they just not care? If they know and do not care, what does that suggest about their other business practices?
Again, we've all stumbled and we've all made mistakes. But you can still see when the effort is being made! =)
Happy bunny trails! Love, Jenna
7 comments
I’m new to this…
My wife sells bath bombs as part of her small business.
Her packaging was made by a “Professional” that said he would make sure she was in compliance. So….. As I read the post on here I have seen some interesting things?
Is there a “definitive clarification” for labeling bath bombs?
The package states it is a “novelty item”.
It is not a cosmetic because it does not beautify, enhance appearance and is not meant to be applied to the body.
It is not a "drug because it does not “treat or cure” anything. ie it is not a moisturizer.
Are there different rules if you sell under $5k per year of that product?
Any thoughts?
Thank you in advance!
Than you for posting about this topic! I’ve been quite curious as a consumer as to what exactly the FDA required from companies.