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    • CommentAuthorDawn
    • CommentTimeSep 20th 2009
      0 points
    I plan on doing a few craft fairs this holiday and have been thinking about adding a couple non-soap items to the inventory but I'm a little nervous with all the FDA regs, etc. I've been thinking about selling a scrub and a lip balm. I know they're all oil and don't require preservative (except for the scrub for water that's introduced by the consumer), so that should eliminate the USP 51, etc. Question #1 - As long as the labeling is correct on the scrub, am I okay without further testing? Question #2 - When I type in "lip balm" at the FDA site, I am taken to a page that is referring to it as a drug. Is this true? *big sigh* Can someone bring light to this subject? Thanks, Dawn
    •  
      CommentAuthorKatnip
    • CommentTimeSep 20th 2009
      4 points
    Dawn, wading into the deep and often muddy waters of FDA regulations can treacherous, tedious, frustrating and downright confusing! In a nutshell, here's what I have concluded:
    FDA's definitions are not common definitions like you and I would think. Examples: acne and bug bites are medical conditions. Therefore, if you claim (on labels, website, or verbally) that your product is a remedy for ANY medical condition, then that product is a DRUG. Drugs have a whole set of rules and regulations to follow, including registering and paying large (thousands of dollars) fees. Most folks like you and me can't afford to let our products get classified as drugs. And if, by chance, the FDA or one of its watchdogs finds you and decides to enforce their laws, you also can be fined heavily and ordered to cease and desist.

    Soap: by the FDA's definition, is in a category by itself. As long as you don't claim that it does anything other than clean, you don't have to do anything special to label or sell it (no list of ingredients necessary, etc.) HOWEVER - if you say that your soap moisturizes, or soothes, or ANYTHING other than cleans? You just caused your soap to be re-classified as a cosmetic. Cosmetics don't have the same rules for marketing that drugs do, but the rules are very specific and strict. Rather than try to repeat the FDA's complete list of rules, you need to look this up on their website, or find a really good book that tells you in plain English how to comply. Here's a quick look:

    Cosmetics are defined as products that beautify or enhance the appearance. Interestingly, aging skin is not considered a disease (thank God!) but just about everything else (eczema, poison ivy, even itchy skin!) are considered medical problems, so be very careful. Cosmetics have to be labeled properly, and that includes soaps that claim more than cleansing, and here are some of the rules: INCI names for all ingredients in descending order, except ingredients of 1% or less do not need to be listed; weight in ounces and milliliters; name of manufacturing location with contact information; expiration dates and batch numbers are excellent ideas, but I can't tell you for sure if they're required but I use them!

    My thought is that by calling your product "lip balm" that the word "balm" implies healing. If that sounds ridiculous to you, remember that this is the FDA we're talking about! And I am accustomed to working with attorneys in my former profession, so this is frustrating, but not unfamiliar to me. Maybe if you called it something else? How about Lip Butter? Lip Gloss? Love My Lips? Just not Lip Therapy, or Lip Fix! Remember, no claims, direct or implied! - or then it magically (as far as the FDA is concerned) your product is *poof* a drug...well, it's an Over The Counter (OTC) drug...but still has to follow all those rules.

    Good luck! And don't take just my word for it - I didn't believe everything I read, but went to the FDA website and read it for myself. Fortunately I am a (former) paralegal and I can read this stuff without falling asleep or ripping my hair out, most of the time. This is why most of us here just make the soap...
    • CommentAuthorDawn
    • CommentTimeSep 20th 2009
      0 points
    Thanks Katnip! I have been reading the FDA website and the information is so chopped up that It's difficult to know if what you're reading is the end and not just a part. I did read that cosmetics that include "aqueous" substances must have the eficacy of the preservative tested. I understand that, I was just wondering if there were other testing rules for non-aqueous cosmetics that I didn't find. Muddy and merky definitely describes the FDA, ha ha. Sometimes I think they do it on purpose.

    Anyway, I ordered Marie Gale's Soap and Cosmetic Labeling book. I'm sure that will answer many of my questions. Are there any other books that might be recommended reading?

    Thanks so much for the info.
    •  
      CommentAuthorKatnip
    • CommentTimeSep 20th 2009
      0 points
    Dawn, Marie Gale's book is considered an industry standard, and it is an excellent book. I'm sure you will enjoy reading it much more than the FDA website. That book is the only one that I know of that specifically addresses the soap/cosmetic labeling issue, but about a year ago a buddy of mine emailed me a link to an e-book set up like a Power Point slide show that was the greatest explanation I've ever seen on FDA reg's for the common folk. Did I bookmark it? Sadly, I did not. I've kicked myself many times for not saving it, because it was such a great little resource. If anybody reading this remembers seeing this, and where I can find it, I promise to save it this time!

    I don't think that the FDA means to be vague, but legal writing is a whole different animal than other types of writing. It's written by attorneys, for attorneys, and they don't really care if non-legal folk can understand it - in fact, they like to be paid for their services to interpret this sort of thing. It's what they do.
    • CommentAuthorZany in CO
    • CommentTimeSep 21st 2009 edited
      3 points
    Q #1 - As long as the labeling is correct on the scrub, am I okay without further testing?

    A: Yes.

    Q #2 - When I type in "lip balm" at the FDA site, I am taken to a page that is referring to it as a drug. Is this true? *big sigh*

    A: Yes. Ditto what Katnip said. "Balm" = "Drug"; change "balm" to "gloss", "butter", "wax", "cream", etc. -- takes it out of the drug category and into the safer cosmetic category. For example, I use "Lip Lube" for my flavored lip balms; "Calendula Cream" for my healing lip balm with herb infused oils. I make no claims about "healing cracked lips" or "prevents sunburn/wind burn" etc. Follow "cosmetic labeling" guidelines.

    TIP: MMS has a template guide for lip balm labels. Think about whether you want the label to be vertical or horizontal on the tube. Check out lip balms on line or at your local drugstore to see which orientation you prefer. With all the info that needs to be on there, I find horizontal to be easier to format.

    Zany in CO

    Edited to add:
    For liquid products: fl.oz./ml (volume)
    For solid products like lip balm: oz./grams (weight)

    Once again, examine commercial products to see how they are labeled.
    • CommentAuthorDawn
    • CommentTimeSep 22nd 2009
      0 points
    Thanks you two! I feel much better now.

    Dawn