What are health claims?

[Genny]

Is it this http://personalcaretruth.com/2012/04/hr-4395-cosmetic-safety-amendments-act-of-2012/
If so, then it's still on the table.

 

[Kansas Farm Girl]

It doesn't mention soap, but you never know how they would interpret the GMP portion and if they make sure they continue the soap exemption.

 

[Robert]

Is there a definitive list of words that are considered health claims or cosmetic claims?

There are some for which the precedent is that they are, and some for which the precedent is that they're not, and everything else is a "maybe". And by "precedent" I don't even mean anything as solid as a court decision!

I have a friend who makes money advising makers and marketers of dietary supplements on this issue.

 

[Robert]

As long as you abide by the cosmetic labeling regulations, which you would have to anyways for body washes.

Unless (in the USA) the body wash is made of soap.

 

[Robert]

We really need someone from the FDA here to explain it all.

But the next person from FDA might say something else. Seriously, this is what keeps them and lawyers in gen'l in business. If laws were simple enough, courts would be empty.

I'll give an example as to how finely the line can be drawn for shampoo. Both Prell and Vidal Sassoon (at least) have been advertised as saying they remove dandruff flakes -- which of course they do -- and that's a cosmetic claim. However, if they claimed to prevent or slow the reappearance of dandruff, that'd be a drug claim. Removing the flakes from the skin and/or plastering the remaining ones down is deemed not to be affecting the structure of function of the body, but the production of dandruff is deemed to be a physiologic process. That one's not actually that hard a line to draw biologically; "moisturizing" is a lot more arbitrary classif'n.

But having only cosmetic claims doesn't get you out of the woods in the USA (or vs. state att'ies gen'l). There's still the FTC, which now says you have to have a good scientific reason for believing the claims you make. This is becoming an issue for dietary supplements, and no reason to think it couldn't be for cosmetics. They're no longer taking the existence of data on an isolated ingredient in a product as necessarily enough reason to think the whole product is effective in doing what that ingredient is supposed to make it do.

 

[Robert]

I agree. Those regs are way out of date. But lately, when the government updates something, it hurts independent business only.

For example, the FCC regulation update a couple years ago mandated that bloggers must disclose when they are given a freebie for review. But news companies did not have to follow the same regulation. This means, Good Morning America does a product review, they don't have to tell you it was given to them for free, nor do they disclose what they get for the kickback when the product's sales go up.

That's not true. The reason the new reg didn't apply to them is that the old reg still did. That's why you see or hear the anmt. at the end, "Promotional consideration provided by...."

Even scientific journals that assess page charges to authors have to include a disclaimer in the fine print explaining that for that reason, the article has to be labeled "Adverisement".

 

[christinemm]

Difference between book or co claims & face to face seller

Hi, I am new here and am reading this old but still interesting and relevant thread.

The issues here are similar to the herb world. Herbalists who make teas, foods, lotions, cremes, salves that have medicinal properties have these laws applied to their practice.

One herbalist I know was discussing this conundrum. Even when there are studies validating that tea tree oil kills skin fungus she is not supposed to make that claim on her products she sells for that purpose. Clear as mud...

Meanwhile I heard a lecture this spring by an RN who is very interested in herbs and plants for healing and wellness. She explained it in a way that cleared it up for me, for the US government:

a book author can publish a book listing plants, oils or whatever as having been used to cure or help symptom X. These are considered historical discussions, especially when specifically framed "the Native Americans used sasparilla for ___
" and "Colonial settlers in the 1600s used X to cure back pain". Book authors are not giving medical advice they are sharing information to people they do not know or interact with. They are not meeting a person and hearing I have X medical problem what can I cure it with?

The nurse shared with us some medicinal qualities of herbs but kept saying I am not selling you a product or service and this is for your information only, so she was protected and not giving out medical advice.

When a person knows someone and talks to them and says "I need something to help my acne" if the person answers them "use this soap" they are in the eyes of the US Government, giving out medical advice. Therefore the person is treating a person when they do not hold a medical license. This is because they met them and interacted with them. (The book author sold information in a book not having a "personal relationship" with the consumer.)

By the way the American Medical Association is behind all this. In America pharmacists cannot give medical advice or recommend treatments. My friend just got back from Italy and had a rash. The local friend she was visiting brought her to a pharmacy and she showed her arm to the pharmacist and he said "buy this drug and use it 3x a day" then sold her an OTC medication that in the USA is prescription only.

So if an herbalist or a soapmaker is at a farmer's market and selling a product that makes a health claim it is considered breaking the law, because they are giving out medical advice.

Herbalists who have training and run an herbalist practice can give out medical advice but they have to keep all kinds of records. One herbalist I buy things like tea and hand salve from just sent us a questionnaire that asked some of our medical history just in case anything she uses in her products may harm us in some way.

The last I knew a few years ago, giving brochures as a separate piece of educational literature was okay. That is why the health food stores still have such brochures written by, printed by, and given to the store free by the vitamin and supplement manufacturers. I see them doing that today, so I question if the law changed and if we really cannot do that. Another example is read the amazon.com supplement product pages, they give a lot of medical claims, on the company websites they usually cite some research. I don't know if they can make the claims due to the research or what. I will say some of it is a stretch though, such as the study said X helped children with attention span then they make a more general claim that it can help everyone with attention span (or whatever).

I am using herbs and herbal infusions in my soaps. I think I am hog tied with telling the real benefits of some of these.

I am thinking about starting a small cottage business via etsy but am not sure I truly have time for it. I'm researching while I make batches of soaps with my own custom made recipes, I'm experimenting.

Thanks for this thread on the forum. This has been informative.

 

[Robert]

When a person knows someone and talks to them and says "I need something to help my acne" if the person answers them "use this soap" they are in the eyes of the US Government, giving out medical advice. Therefore the person is treating a person when they do not hold a medical license. This is because they met them and interacted with them. (The book author sold information in a book not having a "personal relationship" with the consumer.)

It's not the US gov't that's concerned with this, but the state gov't. Even then, if the person is not getting paid by or soliciting business from the individual, the states don't consider it health practice. And there are even ways around that in some states--for instance, the acceptance of a free will offering in the course of "faith healing", which was a loophole my friend Ralph found for NJ, where "faith healing" is defined without reference to religion.

 

[christinemm]

I saw this today, a soap and lotion seller online, look at these claims. I read the FDA page that was linked in another thread about labeling, this:

http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/CosmeticLabelingManual/ucm126438.htm

and this seems suspect. http://www.essential-soaps.com/Night-Cream.html

But I am a newbie and what do I know? Also when selling on the Internet maybe I am confusing product descriptions on the site versus the label attached to the product?

Confused, ChristineMM


Sent from my iPad using Soap Making

 

[Kansas Farm Girl]

If you go to that FDA link and down to this sentence: For additional information, refer to Is It a Cosmetic, a Drug, or Both? (Or Is It Soap)?
you find this:
How is a product's intended use established?Intended use may be established in a number of ways. The following are some examples:

• Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin (pigment) in the skin, or regenerate cells.
• 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." For example, a fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain "aromatherapy" claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use. Similarly, a massage oil that is simply intended to lubricate the skin and impart fragrance is a cosmetic, but if the product is intended for a therapeutic use, such as relieving muscle pain, it's a drug.
.........
Soaps are in a different category unless it is being marketed to do something else:

• is intended not only for cleansing but also for other cosmetic uses,

it is regulated as a cosmetic. Examples of cosmetic uses include making the user more attractive, by acting as a deodorant, imparting fragrance to the user, or moisturizing the skin.
......
This is from the same site
http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm

My understanding is that you can make these types of claims IF you follow the Cosmetics rules and not the soap rules. Soap is regulated by the Consumer Product Safety Commission, not the FDA, as long as it meets the FDA definition of soap:
How FDA defines "soap"

Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when

• the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and
• the product is labeled, sold, and represented solely as soap [21 CFR 701.20].
• ...
• is intended not only for cleansing but also to cure, treat, or prevent disease, or to affect the structure or any function of the human body,

it is regulated as a drug, or possibly both a drug and a cosmetic. Examples include antibacterial cleansers and cleansers that are also intended to treat acne.

If a product

• is intended solely for cleansing the human body,
• has the characteristics consumers generally associate with soap, and
• does not consist primarily of alkali salts of fatty acids,

it may be identified in labeling as soap, but it is regulated as a cosmetic.

Products that meet this definition of soap are regulated by the Consumer Product Safety Commission (CPSC), not by FDA. Please direct questions about these products, such as safety and labeling requirements, to CPSC.
.....
Long-winded, I know and it can be confusing. I don't sell my soap but I do put labels on it for my friends and just call it soap.