Do OTC drugs need to prove that they provide whatever benefit they are claiming or not?

Tagged: fda, otc, regulatory

General

Do OTC drugs need to prove that they provide whatever benefit they are claiming or not?

Posted by Abdullah on June 1, 2022 at 12:27 am

Does an OTC drug become OTC just by stating a drug claim and adding an OTC active ingredient or it is being tested and regulated by authorities to see if it really have any drug benefit or not?

For example: does a soap or cleanser become OTC drug just because they claim acne healing and have salicylic acid in it or they are being tested and regulated by authorities to see if it really does what it says it does and prove it?

If they are being checked and regulated, how does salicylic acid soap or cleanser proves that they are healing or having any drug benefit for acne?

If they are not being checked and regulated then how should someone know if a drug product is really a drug and cures a disease or it is just a lie and marketing?

Abdullah replied 2 years, 5 months ago 5 Members · 13 Replies
13 Replies

Rockstargirl

Member
June 1, 2022 at 2:05 am

The ingredients and % determine if is a drug or a cosmetic. Soap is a cosmetic. So if they make a “cures acne” claim - that is incorrect for a cosmetic. “Helps the appearance of acne” may be more suitable. The claim itself does not make it a drug. The man power of health authorities is not great and lots of this falls under the radar. However the fines levied when caught are no joke. It’s not worth the risk. Research what claims are allowed and the wording before marketing. I believe BP and Sal acid may make acne claims however “ cure” is not a word I would use.
Abdullah

Member
June 1, 2022 at 5:08 am

Rockstargirl said:

The ingredients and % determine if is a drug or a cosmetic. Soap is a cosmetic. So if they make a “cures acne” claim - that is incorrect for a cosmetic. “Helps the appearance of acne” may be more suitable. The claim itself does not make it a drug. The man power of health authorities is not great and lots of this falls under the radar. However the fines levied when caught are no joke. It’s not worth the risk. Research what claims are allowed and the wording before marketing. I believe BP and Sal acid may make acne claims however “ cure” is not a word I would use.

Thanks

One particular question.
Are OTC products controled by regulations to see if it realy do what it claims?
PhilGeis

Member
June 1, 2022 at 10:05 am

By definition, “intent” establishes a drug product. Product claim is the most obvious indicator of intent. As Rockstargirl noted - and you see it in antiaging products with wrinkles, etc. - addressing “appearance” can be a means of maintaining cosmetic status.
In US, simple “soap” (as the metallic salt of a fatty acid) is an article regulated by EPA and CPSC not a cosmetic. Surfactant based soap is a cosmetic.

For OTC drugs, read the relevant monograph. Some require testing to confirm efficacy. https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm
Abdullah

Member
June 1, 2022 at 10:54 am

@PhilGeis thanks.

The particular thing i want to know is this.

For example: 40% glycerin is an OTC active ingredient. you can use 40% glycerin in a lotion, claim for skin protection and register the product as OTC.

Now if you use 40% glycerin in a cleanser, can you register it as OTC and claim skin protection from it?
PhilGeis

Member
June 1, 2022 at 11:04 am

Assume you’re looking at the skin protectant monograph.
What is your intent for the glycerine use?
Rockstargirl

Member
June 1, 2022 at 12:27 pm

Abdullah said:

Rockstargirl said:

The ingredients and % determine if is a drug or a cosmetic. Soap is a cosmetic. So if they make a “cures acne” claim - that is incorrect for a cosmetic. “Helps the appearance of acne” may be more suitable. The claim itself does not make it a drug. The man power of health authorities is not great and lots of this falls under the radar. However the fines levied when caught are no joke. It’s not worth the risk. Research what claims are allowed and the wording before marketing. I believe BP and Sal acid may make acne claims however “ cure” is not a word I would use.

Thanks

One particular question.
Are OTC products controled by regulations to see if it realy do what it claims?

Well.. some is already established (spf filters etc) But you should do testing to back up your claims. The responsibility is of those making the claim.
Abdullah

Member
June 1, 2022 at 1:40 pm

PhilGeis said:

Assume you’re looking at the skin protectant monograph.
What is your intent for the glycerine use?

This was as an example because i couldn’t tell you properly what i wanted to know about salicylic acid in cleansing product.

I am looking at acne monograph.
2% salicylic acid is an OTC active for ance.
Now if it is in a cleansing product, it doesn’t do any benefit for ance vs simple cleansers. So how are all OTC salicylic acid cleansers which doesn’t do anything for ance being allowed to claim so?

Salicylic acid for ance from cleanser is as useless as glycerin for skin protection from a cleanser. Isn’t it?
Abdullah

Member
June 1, 2022 at 1:47 pm

Rockstargirl said:

Abdullah said:

Rockstargirl said:

The ingredients and % determine if is a drug or a cosmetic. Soap is a cosmetic. So if they make a “cures acne” claim - that is incorrect for a cosmetic. “Helps the appearance of acne” may be more suitable. The claim itself does not make it a drug. The man power of health authorities is not great and lots of this falls under the radar. However the fines levied when caught are no joke. It’s not worth the risk. Research what claims are allowed and the wording before marketing. I believe BP and Sal acid may make acne claims however “ cure” is not a word I would use.

Thanks

One particular question.
Are OTC products controled by regulations to see if it realy do what it claims?

Well.. some is already established (spf filters etc) But you should do testing to back up your claims. The responsibility is of those making the claim.

My point was also this.

If salicylic acid from cleanser is useless, how do all these salicylic acid OTC acne cleansers back up their claims?
MarkBroussard

Member
June 1, 2022 at 2:01 pm

The determination of OTC status of a product is a function of:

(1) Using an OTC monograph ingredient in percentage ranges as defined in the monograph

(2) The intended use is that defined in the monograph (for instance: Acne)

(3) This allows you to use the claims language allowed in the monograph (ie: Acne)

In some instances you will need to conduct an assay to determine the stability and concentration of the active in your specifc formula. But, you generally do not have to conduct studies on individuals to prove that your formula is effective in alleviating the targeted condition.
PhilGeis

Member
June 1, 2022 at 2:31 pm

Please look at the specific monograph - some do require specific testing - e.g. spf determination for sunscreen products.
see monographs at https://www.accessdata.fda.gov/scripts/cder/omuf/index.cfm

I gather you’re concerned with the skin protectant monograph - that does not specify testing.
https://www.accessdata.fda.gov/drugsatfda_docs/omuf/OTCMonograph_M016SkinProtectantDrugProductsforOTCHumanUse09242021.pdf

Further - please understand these are drugs products and must comply with relevant regulations under 21CFR for registration, GMP’s etc.. A product can also be both a cosmetic and a drug and comply to both sets of regs.
https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap
Abdullah

Member
June 1, 2022 at 2:35 pm

@PhilGeis @MarkBroussard got it

Thanks a lot
Pattsi

Member
June 2, 2022 at 3:47 am

Flow chart summary.

https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/New-Drugs/Process/NDD_APPL_Organogram.pdf

You can contact your local state authority if your formula requires clinical trial or not.
Abdullah

Member
June 2, 2022 at 7:49 am

Pattsi said:

Flow chart summary.

https://cdsco.gov.in/opencms/export/sites/CDSCO_WEB/Pdf-documents/New-Drugs/Process/NDD_APPL_Organogram.pdf

You can contact your local state authority if your formula requires clinical trial or not.

Thanks