FDA Globalization Act

[Scented]

Hey peeps ... WSP is doing a survey to take the responses to the Hill. Posted for you to take part. If you don't know about the Globalization act ... they want to charge a fee and require a lot of other restrictions on American makers.

http://www.surveymonkey.com/s.aspx?sm=DosuOVE0LC4E4oggi0M12g_3d_3d

[beau's mama]

I just wanted to bump this up.

There has to be more than 26 small businesses here!

[Scented]

Oh there are, but probably none thinking it will affect them Maybe what isn't understandable to everyone is the fees they'll pay and the restrictions they'll be under when/if this goes into a proposed bill.

I finally heard from one of my senators, but still it seemed like a brush off unfortunately.

[Luci]

I sent my info in immediately after receiving Debbie's newsletter. Everyone should be concerned or we will become the new bootleggers.

[birdieluvr76]

I don't make any of the products that this is in reference to, but I filled it out from my perspective as a buyer.

[guppygirl]

Thanks Scented - just filled it out.

[Brat]

Got mine filled out. Thanks Scented!

[MissMary]

Aside from the fee, frankly - I think it's a good idea. I'm not sure why people are scared of it. Because it will require what? That we register our ingredients? Supposed to do that anyways. That we report adverse reactions? I think that's a HUGELY great idea. Document good manufacturing processes? I work in a sanitized environment. For the cosmetics I do buy, it'd be nice to know the same.

I think a lot of this is aimed at hitting the fly by night companies who don't care what they do to people.

I DO want the fee changed to sliding scale. If a company's profits don't exceed say... $1000, no fee... $2000 is $20, and for each $1,000 add $10. But under the conditions, after paying the fee, cosmetic submissions are free.

[Scented]

But that isn't what is proposed. What you want and that this group of people thinks the fees are too small are two hallucinatory things.

Actually, hope you don't make at home in what you think is a sanitized kitchen, because you won't get to do that either.

And the fee isn't just $2,000 a year. It's fees for a slew of other things, which include having every one of your products tested -- not just tested for safety and the stuff that's in it ... also for being able to sell to another country. You may not even offer to sell to another country, but you still get to pay the fee to be sure your stuff can go global. Every formula. So if you can afford to pay rent or buy a building and take it to code, pay for the inspection fees, pay your fees and pay for all the different testing of your products, insurance and for increases in oils ... great.

If you want to go support the cause. Go do it. Considering you just started in soaping, good luck getting your business off the ground.

[ForHisGlory]

Done!

[candlelady]

Done!

[yoyo]

Done!

[kidsngarden]

The certified kitchen alone would get me. While my kitchen is scoured especially before making lotions, they want a whole seperate facility.

I really don't want to have the red tape and fees associated with it every time I change a scent or add a different color. I don't want to pay a lab tech to test all my stuff every time there is a change. Testing lotion costs enough.

Like Scented said, $2000 is just the tip of the iceburg.

I'm filling out the form!

[heirloomoriginals]

I filled it out as soon as I got it.

Steph

[MissMary]

But that isn't what is proposed. What you want and that this group of people thinks the fees are too small are two hallucinatory things.

Actually, hope you don't make at home in what you think is a sanitized kitchen, because you won't get to do that either.

And the fee isn't just $2,000 a year. It's fees for a slew of other things, which include having every one of your products tested -- not just tested for safety and the stuff that's in it ... also for being able to sell to another country. You may not even offer to sell to another country, but you still get to pay the fee to be sure your stuff can go global. Every formula. So if you can afford to pay rent or buy a building and take it to code, pay for the inspection fees, pay your fees and pay for all the different testing of your products, insurance and for increases in oils ... great.

If you want to go support the cause. Go do it. Considering you just started in soaping, good luck getting your business off the ground.

Like I said, I don't agree with the fee, or fees. But a kitchen - I do agree with. I don't expect someone to be making dinner next to my soap. I make my soap in a separate room, which is totally cleaned down, and not in the same room as where I make candles. Or someone who just fixed shrimp on the counter to make soap there too. A facility can entail a single room, that is used only for soap making and only products of soap making are stored there.

Additionally, I've read the actual act (old and new) and from what I read - part of the $2000 is to register your facility, and your inspections. Nor does it discuss any fees in regards to registering formulas. It DOES mention fees for importers and such, but NO other fees. Also, the reinspection window is every FOUR years.

It DOES require reporting adverse effects. This is a HUGE step forward I feel.

Now, the FOOD section DOES mention many more fees, and the IMPORT section mentions fees if you operate as an importer from a foreign country with limitations.

I appreciate those who want to take action against it. It's their right - but a lot of those standing behind this aren't getting the correct information.

Additionally, many of the links posted are to an outdated draft.

The new draft also exempts repackagers - which for many makers of cosmetics, this is all they do in regards to micas. It does NOT apply to soapmakers, because this act does not propose soap be labeled as a cosmetic (and there are no laws on the books claiming soap is a cosmetic, therefore is not regulated as such, in fact, it's expressly written that a product labeled only as soap and created as true soap is NOT a cosmetic).

They can also waive the fees as determined by the HHS Secretary. Additionally, it also has implemented a sliding scale to an extent (not the set fee) basing registration on number of facilities, cost of running that facility, and other factors.

This is also determined as to whether they decide to stick to the original wordings that drugs are also contained in cosmetics and are, for intents and purposes one in the same.

These changes are coming about because people are discussing what's important to them. I DO believe we need some sort of regulation. Maybe not as stringent for small businesses to an extent, but one of the biggest parts for me is the adverse reaction reporting.

Aside from the fees though - I still can't see much ado about most of this. No one has come up with any good reason why the rest of it shouldn't go through, aside from the fees.

How long I've been making soap has squat to do with it. (Especially since soap making doesn't apply here.) I intend to expand as I can, carefully and cautiously and eventually this could affect me. But if soapmaking is the prerequisite, then this discussion is moot, because if only soapmakers are allowed to have an input and they aren't even affected... guess your point is invalid anyways.

[SherriLynn]

The bill your referring to has been revised many times from the original document,, and it will continue to be revised throughout the process of putting it into a bill. I saw the same thing happen when the food handling laws came into effect.

I am licensed in food, and yes I do agree that lotions,soaps,balms.. etc.. all need to be made in an inspected, licensed kitchen, just like food products do.

I mentioned a while back about our experience with purchasing handcrafted lotion a show a few years ago, only to find hair in it. Ewwww!!! Who knows what pet or person was wandering around that house with hair falling out. That was reason enough to start making our own lotions, balms and soaps.

Clean kitchens are not only important, but so are the utensils your using for mixing. Are your bowls stainless steel, so they dont' absorb and retain bacteria like plastic and ceramic does? Are you wearing plastic gloves when packaging body products, so your body oils are not contaminating your product? Are you washing your hands, your counters your utensils before starting to package lotions? Are your body products packaged on wood tables, counters, cermic tile, all things that can absorb liquids and create bacteria from them? Are you using a plastic spoon or spatula for mixing? Even cleaning those surfaces on the top with bleach does NOT make the counter or utensil clean,because they're made of absorbant materials and the bacteria is held inside, under the surface. Thus the reason for using stainless steel certified kitchens, with stainless sinks, counter tops, utentils etc. Stainless does not absorb.

As far as fees,,, heck, these bills always start with out of whack and high fees... I'd venture to say you'll see the same type of sliding fee scale that you see in food producing. It's usually determined by amount of sales by the company. I know in our state, it is.

As far as labeling ingredients,,, ABSOLUTELY!!! and it should have started a long time ago. We have become an allergen world. When I started packaging my gourmet line, you didn't hear of many allergens. Now your required , by law, to list transfats, soy allergens, dyes used, milk allergens...because of the huge amount of people allergic to those ingredients. In my opinion every lotion, balm, soap, lipstick, cosmetic or anything applied to your skin, should be listed by ingredient, to protect those who have allergens.

For those worried about stainless kitchens,,, ask your church, the American Legion or VFW, local banquet halls. I lease a kitchen at a banquet hall, for $75 a month for up to 5 uses. They take care of all the state licensing requirements, etc. They have all the stainless steel utensils I need and many of these places rent their kitchens for very cheap.

Testing, making sure products are safe, ABSOLUTELY and something that shouldn't be taken for granted.

I realize most people disagree with this type of regulation,,, but you'll be darned glad you follow it, should you be sued for someone using one of your products, that doesn't have ingredients labeled,that might contain ingredients that could cause an allergic reaction, hospitalization or even death Be proactive about this,, keep your customers and your business safe... Just my 2 beans for today....

[lsg]

Using a licensed and inspected facility does not guarantee that one won't find foreign material in a product. Who hasn't found a hair in their food at a restaurant or something foreign in a bath and body product?

[SherriLynn]

The chances of it are slim...and when found..is investigated. It doesn't go unwarranted like it did with the person who made the tainted lotion that we bought.

Who do you report the incident to, other than the lotion was made in someone's house. There's nothing regulating them, no place to report it except to public health. Which we did, however, because there were no regulations about it.. nothing was done.

I'm not saying I agree with everything in the proposed bill, but I do think some type of regulations are needed.

[cindym]

Like I said, I don't agree with the fee, or fees. But a kitchen - I do agree with. I don't expect someone to be making dinner next to my soap. I make my soap in a separate room, which is totally cleaned down, and not in the same room as where I make candles. Or someone who just fixed shrimp on the counter to make soap there too. A facility can entail a single room, that is used only for soap making and only products of soap making are stored there.

Additionally, I've read the actual act (old and new) and from what I read - part of the $2000 is to register your facility, and your inspections. Nor does it discuss any fees in regards to registering formulas. It DOES mention fees for importers and such, but NO other fees. Also, the reinspection window is every FOUR years.

It DOES require reporting adverse effects. This is a HUGE step forward I feel.

Now, the FOOD section DOES mention many more fees, and the IMPORT section mentions fees if you operate as an importer from a foreign country with limitations.

I appreciate those who want to take action against it. It's their right - but a lot of those standing behind this aren't getting the correct information.

Additionally, many of the links posted are to an outdated draft.

The new draft also exempts repackagers - which for many makers of cosmetics, this is all they do in regards to micas. It does NOT apply to soapmakers, because this act does not propose soap be labeled as a cosmetic (and there are no laws on the books claiming soap is a cosmetic, therefore is not regulated as such, in fact, it's expressly written that a product labeled only as soap and created as true soap is NOT a cosmetic).

They can also waive the fees as determined by the HHS Secretary. Additionally, it also has implemented a sliding scale to an extent (not the set fee) basing registration on number of facilities, cost of running that facility, and other factors.

This is also determined as to whether they decide to stick to the original wordings that drugs are also contained in cosmetics and are, for intents and purposes one in the same.

These changes are coming about because people are discussing what's important to them. I DO believe we need some sort of regulation. Maybe not as stringent for small businesses to an extent, but one of the biggest parts for me is the adverse reaction reporting.

Aside from the fees though - I still can't see much ado about most of this. No one has come up with any good reason why the rest of it shouldn't go through, aside from the fees.

How long I've been making soap has squat to do with it. (Especially since soap making doesn't apply here.) I intend to expand as I can, carefully and cautiously and eventually this could affect me. But if soapmaking is the prerequisite, then this discussion is moot, because if only soapmakers are allowed to have an input and they aren't even affected... guess your point is invalid anyways.

Seems you are making a generalization here. I do not and would not make any bath and body product next to any food I would ingest. Soap included. This is an important topic for all of us, if you don't get that, yourt problem. Safety and great products is what we all strive for.

[cindym]

Oh by the way guys, be sure to fill out the survery, it is important.

[hawaiiansun]

Using a licensed and inspected facility does not guarantee that one won't find foreign material in a product. Who hasn't found a hair in their food at a restaurant or something foreign in a bath and body product?

true true true agree...

[lsg]

Oh by the way guys, be sure to fill out the survery, it is important.

Done:smiley2:

[jenniejr]

Done! And damn proud of it!!

[MissMary]

Seems you are making a generalization here. I do not and would not make any bath and body product next to any food I would ingest. Soap included. This is an important topic for all of us, if you don't get that, yourt problem. Safety and great products is what we all strive for.

If you haven't read my responses, I have NEVER said that EVERYONE does certain things. I said this bill would stop those who DO.

Discussing sanitation must mean that EVERYONE does it right? Because they post on a forum they do? If they DO use a sanitized area - then this bill wouldn't affect them, now would it? Seems like you may be one of the ones who DOES make soap on a counter you cleaned with Windex.

I guess it doesn't matter about all those people and the little kids who are hurt by fly by night idiots who can throw anything into soap (including those metal shavings from not using the proper "drain cleaner") and who cares if they get screwed right? Let's keep idiots - all over the US (idiots mind you, not the safe and sanitized people who do right) from not only hurting people, causing burns and scarring, but to keep them from hurting the homecraft area.

Again, the issue remains- that I've said everyone makes food next to soap - BUT I do know that a few here do, because it's been said in posts! (When they've mixed up dinner and their soap utensils, and doubling using crock for soap AND dinners.)

[hawaiiansun]

Are we suppose to be sanitized??? :confused: On dumb me I make soap on the kitchen floor. yikes I need a good teacher.

:laugh2: