FDA Questions & Answers

It is getting so suspenseful.I'm battling tooth extraction problems,that is why I have not called,but I will soon,because no way will I use my street address.

woo hoo! Don Havery of the FDA who is on the conference call said that a web site or a PO box are just fine!!! That the customer just needs a way to reach us!

regarding INCI names...

The point of the regulations is to tell consumers what is in there - clarity is everything. So...

1 - Common name (with INCI name in parens) = good, OR
2 - Common name only = good
but just INCI names... not really good because most consumers don't speak Latin...

NOTE: US only. If you want to go outside the US you need to follow their rules...

"The safety of this product has not been demonstrated" does not to be put on labels.

I'll come back and tell you why after the conf call break.

I wonder if we could get this in writing?

IrishLass

members can get access to the recording, which should be good enough, I imagine.
and we can send Debbie questions she will put to him for a response in writing.

That Elmo is dancing Thanks for the info and doing the work.

Other things - your web site is considered part of the labeling! it's called collateral labeling. so you have to be careful what you say there re: claims. AND TESTIMONIALS COUNT TOO!!

(I will pull these together and post as a sticky somewhere but whatn to get it out now).


LIP BALM - the word "balm" is ok - it's not going to be considered a drug claim unless there is other content which takes it in a drug direction.

(DON just offered to answer all questions by email -- [email protected]).

OK -

FIRST AND FOREMOST - SOAP IS NOT A COSMETIC. But as soon as you go past soap=soap then you move into cosmetic.

COSMETICS cleanse, moisturize, or change the APPEARANCE of skin. If you say it changes the skin physically - it's a drug; if it treats or prevents or protects - it's a drug! If you talk about any specific disease (rosacea or acne, for example) it's a drug.

Any product that even hints or suggests that it provides some protection (even naturally occurring in ingredients) is a DRUG.

Ingredients that impart color MUST be approved for that use by the FDA - some colorants also need certification (mfg of the colorant gets that).

Oh thank god! I'm gonna go yank my street address off those labels ASAP!

Still haven't received a call back from Mary Toro with the Consumer Product Safety Commission. They are the ones who regulate SOAP.

So far, what I've been told is that a PO Box will only suffice if you have a "Commercial Business" address.

Hopefully, she will have the answers.

As for Cosmetics (FDA), the answers have been conflicting.

Either way, an address is required on all products. FDA or CPSC.

I suppose we (homebased businesses) are a small enough demographic that the question isn't raised that often?

As I stated before, I will continue to use my home/business address. It's why I have a home occupation license.

Poo.....I thought it wasn't required per Carebear's post. But I guess I'm wrong. Thankfully I got busy and didn't have time to change my labels lol. I'll just suck it up for now. I haven't had any psychos yet thankfully!

yes, soap isn't a cosmetic.

BUT I think I heard that. according to the FDA dude, if you add color it becomes a cosmetic. It was a little confusing at that point, so I'd like to clarify that so will send him an email.

Is that guy good with anyone contacting him? Because I have an insane amount of questions. I feel like this is one of those things where issues are dealt with by individual agents who all have different opinions.

I got my PO Box...6 Dollars a month,don't need a business license in my town,waiting for my state tax id have to study the labeling book.....

Labeling Clarifications

Hi -

This thread was brought to my attention and I thought maybe I could help clarify some of the labeling points.

Name and address ARE required. The regulations say "physical address", so technically a PO box doesn't qualify. Website definitely doesn't qualify.

IF the name on the label is listed in a PRINT phone or city directory (not just directory assistance or online), then the street address can be omitted, but the city, state and zip code still need to be on the label.

Ingredients are required on all cosmetics. Soap is classed as a cosmetic if there are any claims made other than "cleansing" and "soap". So if you say it's moisturizing, soothing, exfoliating or anything other than "it cleans" and "it's soap", and ingredients are required.

Ingredients need to be in INCI format. HOWEVER, the regulations specify the 2nd edition of INCI, which uses common names. Subsequent editions changed to include the Latin names --- so technically, either common, common with Latin in parenthesis (7th edition) or Latin with common names in parenthesis (current) are acceptable.

I think that covers most of the issues brought up ... I've created a Quick Labeling FAQ (http://www.mariegale.com/labeling-faq) on my website which addresses these points and a few others. Check it out and if you have other questions that aren't addressed, email me and I'll add them.

I set this to notify me if there is a response, so if you have any additional questions and post them here, I'll answer.

Marie

Off topic here but I want to say welcome to the forum to Marie Gale. I'm thrilled that you've come onto the forum to clarify labeling info. It's been a topic that has been extremely confusing and frustrating for many members.

Welcome - thanks!

Thanks for the welcome.

I'll be glad to answer any questions that come up.

Marie

Re: Labeling Clarifications

MarieGale said:

Name and address ARE required. The regulations say "physical address", so technically a PO box doesn't qualify. Website definitely doesn't qualify.

Click to expand...

Marie, in the recent conference call with Don Havery of the FDA (through the Indie Network), he told us that as long as the contact information was there, it was ok. He said PO Box, email, or web site (as long as web site has contact info) are all acceptable and that a physical address is not required, despite the way it was currently written.

I have a PO Box and the rest of my label states my town,zip code and state.
There is no way I would give away my home address.
This is something everybody should think about how dangerous this could be having your private home address on a label !
Why don't I attach my house keys with the label, too
If I would get in trouble with the FDA,bring it on.

There are a lot of sick people out and about, I think a PO Box is enough,since they have all the info about where you live etc.....