Labels with Drug Claims

[christinak]

Active Ingredient: (Calendula) Cosmetic Ingredients: (Olive Oil, Beeswax)

Is this all I would have to do for the ingredients for a salve that boasts the medicinal properties of calendula?

I've read a bazillion posts on a trillion websites, inc. FDA...labeling is sort of a pain

 

[christinak]

I forgot to mention that it's an infusion of calendula IN the olive oil....

 

[melstan775]

What is the claim you are making?

 

[christinak]

Healing Salve....sorry, lol

 

[melstan775]

Check the panels of an aspirin container for drug labeling requirements, and copy. Label as a drug labels, and you'll be golden.

 

[christinak]

Thanks! I've been reading the FDA site and it seems that the only diff between cosmetic and drug are the "active ingredient" portion. I am assuming the active ingredient is the one attached to the claim in a cause/effect kinda way

 

[sistrum]

You should probably check more that just labeling requirements if you planing on making a product with claims that puts it in the "drug" category.

 

[christinak]

Thanks sistrum, what do you suggest? It is so weird that it's such a simple recipe...so much hooplah around it! What other checking are you referring to?

 

[christinak]

Is it possible to not call it healing but include a description of what calendula is good for...like on a hangtag? Would that bring it back down to cosmetic category?

 

[Genny]

Thanks! I've been reading the FDA site and it seems that the only diff between cosmetic and drug are the "active ingredient" portion. I am assuming the active ingredient is the one attached to the claim in a cause/effect kinda way

You can't just label it as a drug. Drugs have to be tested and receive premarket approval from the FDA. Also, all drug manufacturers have to adhere GMP guidelines during manufacturing.

http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/UCM2007005.htm
http://www.fda.gov/Drugs/GuidanceCo...ion/DrugRegistrationandListing/ucm2007058.htm

 

[Genny]

Is it possible to not call it healing but include a description of what calendula is good for...like on a hangtag? Would that bring it back down to cosmetic category?

No. If you imply in any way that any ingredient in your product can heal, treat, prevent any disease or affect the structure or any function of the body (human or animal), then your product becomes a drug.

You can't give handouts with what the ingredients do, you can't direct them to websites that will tell them what the ingredients do and by putting "Active ingredient" on your label, you are implying that it treats something.

 

[paillo]

Also, one of the first questions my insurance agency (RLI) asked me was whether I made any medical claims on my products. If so, they would not have insured me.

 

[green soap]

Is it possible to not call it healing but include a description of what calendula is good for...like on a hangtag? Would that bring it back down to cosmetic category?

Do not call it healing. If it is a cosmetic, you have to follow the FDA labeling guidelines, this is not hard at all. If it is a drug (healing claims) then you have to PAY the FDA to test it for you. This would close many of us down (it would close me down at least).

'Calendula salve' or something like that would work well. You can have information on the side (signs, brochures...) describing the use of calendula and calendula infusions over the years. Still, be careful about medical claim even on signs that are not on the product.

Another suggestion is to look at the way Burt's bees label their products. They are wonderful and healing, but I believe they are not labeled as drugs. For example, their "hand salve' has as a description '...protective hand salve......specially formulated to deeply penetrate skin....." no health claims anywhere. They have comfrey root extract in there, a well known healing herb, but no health claims about it.

It is an exercise in semantics more than anything else.

 

[AlchemyandAshes]

I make salves and tinctures, and only list them as a "salve" or "tincture". I list all (every!) ingredients with INCI labeling - I don't list "active ingredients". I don't list what ailment it's for, and any of its "healing" properties.
http://www.etsy.com/listing/108139631/dandelion-clover-nettle-salve-with-tea?
I leave it up to the consumer to research and decide what they want to use it for. Most folks looking for a Calendula salve will know what it's used for. Herbalism takes research, but it is all about being able to take care of yourself. Supplying a product for people to do with as they please (as they will do anyway), as long as the are informed of the ingredients, shouldn't require the FDA's approval, in my opinion.
It's a touchy subject with herbal products, with lots of grey area.
There are tons of Etsy sellers (as well as other internet sites) with all kinds of claims listed. How they get away with it, I'll never know. I guarantee they have not been registered and lab tested. I guess the FDA is busy with bigger fish. There is a section on the FDA website that states if there is any implied use (for curative properties) or if the product is publicly associated and used as a drug, it should be labeled with an active ingredient. This is where things get a bit sticky for me.
Is that the only requirement- an active ingredient?
What about registering the product and intended use with the FDA?
Lab testing for safety and efficacy?
How do all these supplement/diet companies get away with their outrageous claims?
Salves, ointments, balms, tinctures and the like are most likely associated with "healing" (think Neosporin ointment). However, my salves could be used as a cuticle conditioner (cosmetic), skin barrier for hair color (cosmetic), moisturizer (cosmetic), used on heels and feet for moisturizing and exfoliation (cosmetic), essential oils can be used as fragrance (cosmetic)...so it gets to be a bit of a "grey area". Tinctures and Extracts can be used for "spiritual" or "ritual" purposes (or as a cosmetic fragrance like Vanilla extract), so that takes care of those, as the FDA doesn't regulate those, unless I'm stating an internal (healing drug) or cosmetic use.

I would be interested to hear how others handle this situation...

 

[christinak]

Thank you everybody for your input. I have learned some things that I was wondering about! Especially to you, Shawnee; those are all points I was implying from my short post

I thought just saying the name of an herb made it a drug, that's why I was trying to figure out what I could do. I have been making infused salves for so long and would love to sell them but didn't know if it was possible. I know so many people sell them online but I am the kind of person that gets caught if I do one thing out of step Im kinda gunshy when it comes to breaking any rules.

There is a clear section in the FDA that does say if there is an implied use or if it's publicly associated and used as a drug that you just need the proper label (active ingredient). I'd say that herbs would fall under that category. It says nothing about having to test and approve each product.

 

[AlchemyandAshes]

This is a good reference to the dilemma of not putting the claim on the label, but using brochures and such to promote the products intended purpose/claim:

Claims made in advertising but not on product labeling are regulated by the Federal Trade Commission, although advertising claims can be used to establish a product's intended use.

http://www.fda.gov/Cosmetics/ProductandIngredientSafety/ProductInformation/ucm127054.htm

 

[VanessaP]

Even using brochures and other promotional material for the products' intended purpose can classify it as a drug.

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:

• 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.

 

[AlchemyandAshes]

Even using brochures and other promotional material for the products' intended purpose can classify it as a drug.

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

To clarify, I think it's stating that if your labeling indicates your product is a "cosmetic", but your marketing insinuates medical claims, the FDA can use your marketing information as "intended use" and would consider your product a "drug", which has many more regulations and requirements than a cosmetic. Lots of supplements (especially diet products) use this method...the product will just state the ingredients, but the marketing and advertising will lead you to believe the product acts as a drug (heals, cures, etc). Seems like that violates the FDA laws...so how do they continue to "get away with it"? There must be some legal loophole that they use...
I contacted an accomplished and successful (and very educated) herbal product manufacturer in California asking her how this effects her products (tinctures, ointments, etc...I would consider her claims "herbal medicine")...her products are so creative and awesome, I just wonder what her situation is regarding this. Hopefully she gets back to me and I can share her "real world" information instead of an FDA reply directing me back to their guidelines page...

 

[jcandleattic]

I contacted an accomplished and successful (and very educated) herbal product manufacturer in California asking her how this effects her products (tinctures, ointments, etc...I would consider her claims "herbal medicine")...her products are so creative and awesome, I just wonder what her situation is regarding this. Hopefully she gets back to me and I can share her "real world" information instead of an FDA reply directing me back to their guidelines page...

And hopefully if she is making any claims, she IS following FDA R&R's...
Doing something the right way, and having real world experience are not always synonymous unfortunately...

 

[new12soap]

You can't just label it as a drug. Drugs have to be tested and receive premarket approval from the FDA. Also, all drug manufacturers have to adhere GMP guidelines during manufacturing.

http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/UCM2007005.htm
http://www.fda.gov/Drugs/GuidanceCo...ion/DrugRegistrationandListing/ucm2007058.htm

This.

Of course there are a lot of people that do it, and a lot of people get away with it. That doesn't make it right, and it doesn't make it legal. I'm sorry, but it isn't a "grey area" IMO. The FDA is very clear about what constitutes a drug and how they have to be handled and labeled if selling to the public. The "real world information" that someone is getting away with it is anecdotal at best. What you (the OP and PP) or anyone else chooses to risk is your business, but encouraging others to disregard the regulations is IMO irresponsible.