Labels with Drug Claims

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Parke Co. Grapevine

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I want to say Thank You, to everyone for this discussion so far. It is very, very helpful. I know Christinak, it all sounds weird. According to the FDA, we cannot just be simple and say what the soap is IF the customer is going to buy with preconceived notions about some item's healing or medicinal properties. ? Gives me some new research to do and new info to 'chew' on with hubby concerning any soap business activities.

Thanks again, esp. to Genny.
 

SoapPapaw

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Thank you all.
I reviewed the FDA rules - no label requirements for True or Pure Soap.
Cannot say, moisturizing, softening, healing, hydrating, or any other term that says the soap improves or changes the skin. If you do then it is a drug or cosmetic and follows rules for those products.

I reviewed MarieGales blog. I can say on the main label:
(company name) Papaw's Soap Works
(Tag line) Made the Old Fashioned Way
(Soap name) Papaw's Back Woods
(Somewhere separate from name) With Pine Tar

Or

(company name) Papaw's Soap Works
(Tag line) Made the Old Fashioned Way
(Soap name) Grandma's Back Porch
(Somewhere separate from name) Contains 6% Shea Butter

Or

(company name) Papaw's Soap Works
(Tag line) Made the Old Fashioned Way
(Soap name) Aunt Betty's Brew
(Somewhere separate from name) Aloe and Vitamin E Enhanced

I know I will get feed back.
 

christinak

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That seems ok to me, Frank. You are not making any claims yet you're listing the ingredients.
 

SoapPapaw

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Also you can have Informational Panels on another part of the packaging like:

"Gets an A+ on moisturizing" - Sarah M

Or

"Get that Baby Softness your skin deserves"
 

la-rene

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I came across this one today... (I will paraphrase.)

I've heard that your products... (cure stuff)...
The FDA prevents us from using the word cure... but we have hundreds of testimonies... have been so delighted with our products ... treating their conditions.... They go on to state how the healing of the oils is wonderful....

I have to say that it's really disheartening for anyone who is trying to do right to see a possible competitor selling really expensive stuff with impossible and FDA illegal claims all over the place on their very beautiful and compelling website.

It seems to me that if you disregard FDA guidelines and tout your products' healing properties it's an unfair advantage in the popular, upscale, handmade, no chemical, good for you, green product market. Honestly, if I were an affluent soccer mom looking for the next best spa product for my and my babies skin, I would shop at the website of the people with these claims because that is what I want to hear. I would not have done my research to know that Jane Soapmaker has the same stuff in there, but sells it $4 cheaper a bar.

The bad thing is, I've seen so much of it lately! Ugh!!
 

Genny

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Also you can have Informational Panels on another part of the packaging like:

"Gets an A+ on moisturizing" - Sarah M

Or

"Get that Baby Softness your skin deserves"

The informational panel is for your ingredients, warning statement and name & address.
 

christinak

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Frank, I am pretty sure you cannot have any claims on your packaging...even testimonials.
 

SoapPapaw

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From the FAQ section om Marie Gale's blog
Start Quote
What else can go on a label?
You can put whatever you want on the informational panels (not the front) to tell about your product, how great it is and all that. The informational panels are for providing information to the consumer.
End of Quote

So as long as it is not on the front you should be able to provide a panel that says, "how great it is and all that."

I think that could include a testimonial.
 

Genny

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From the FAQ section om Marie Gale's blog
Start Quote
What else can go on a label?
You can put whatever you want on the informational panels (not the front) to tell about your product, how great it is and all that. The informational panels are for providing information to the consumer.
End of Quote

I'd double check with the FDA or CPSC before doing that, just to be sure if I were you.

Honestly, there's no way I could fit anything else on my informational panel. It's hard enough fitting the ingredients, warning statement, address & my website on it and make sure my letters aren't too small.
 

MarieGale

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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
 

melstan775

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Wow. That was a ton of information. Thank you Marie for taking the time. Now I am so curious about this and other things. I will chew it over and try tO narrow down what I mean before I post. Have a great time at the conference!
 

Nevada

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Miscreants abound!

Search for "Tea Tree Soap" in Etsy, eBay and Amazon

Lemongrass and Tea Tree Oil Soap Bar 5 Ounces by Nubian Heritage
Paul Mitchell Tea Tree Body Bar Soap 5.3 oz. / 150 G by Paul Mitchell
PediFix FungaSoapLiquid with Tea Tree oil, 6 oz. by Pedifix
Dr. Bronner's Magic Soaps Pure-Castile Soap, All-One Hemp Tea Tree, 5-Ounce Bars (Pack of 6) by Dr. Bronner's Magic SoapsBar Soap-Tea Tree Therapy 1 Bar by Desert Essence
The Body Shop Tea Tree Body Wash, 8.4-Fluid Ounce by The Body Shop
Tea Tree Therapy Vegetable Base Soap with Tea Tree Oil -- 3.5 oz by Tea Tree Therapy


Because of consumer perception. It's the same reason that if you make whipped shea butter, you have to call it something else, like Whipped Body Butter. Or, if you make Tea Tree Soap, you have to call it something else.




http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm

"How is a product's intended use established?

Intended use may be established in a number of ways. The following are some examples:

Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.
Ingredients that cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.

This principle also holds true for "essential oils."
 

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