Update on Cosmetics Act Legislation

I wanted to provide you with an update on the latest news and events from Washington regarding the development of policies that could affect the soap and cosmetics industry in the future. On Thursday, April 18, FDA Commissioner Hamburg testified in front of the Senate Appropriations Committee regarding the FDA budget for the next fiscal year (FY 2014).

In the proposed budget submitted earlier this month by the President to the Congress, the Administration, just as they did last year, called for the establishment of new fees to be imposed on the cosmetics industry in order to stand up a more rigorous regulatory regime. It’s important to note that this is just a proposal at this point and has been introduced for the purposes of discussion. We are still a ways off from any new policies being seriously considered by the Congress, let alone enacted into law.

As you know, I, and other stakeholders from a wide spectrum of the cosmetics industry have been meeting with members of Congress and their staffs as well as the FDA to discuss any potential changes to the regulations impacting the industry and to make sure that the small businesses that make up our industry are protected as best they can be from potentially burdensome new rules and costs. While we’ve made a lot of progress, there is still work to do.

The President’s FY14 Budget proposes 21% increase over recently enacted levels to take care of all of the Food, Drug, Medical Device and Cosmetic industry. Of all of proposed new user fees, $19 million would come from a new mandatory and annual cosmetics user fee, to be to be paid by domestic and international cosmetics manufacturers. This is the second consecutive year FDA has proposed a cosmetics user fee. Congress took no action on the proposal last year. Any bill that affects the cosmetics industry should include small business exemptions from fees. That has been our message from the start and remains our clear and consistent message.

Currently, there is one bill in draft form that has not made it out of committee that would affect the cosmetics industry. It does contain small business exemptions. You can read the full draft of the bill here. This bill is still in committee. I will keep you posted if anything changes with the status of the proposed bill.

I know this is a lot of information, but I thought it was better to share more with you about what’s going on rather than have you not hear about it or not get the full story. Again, there’s a big distance between where we are now and any potential changes to regulations going into effect, but as you can see, the discussion is still open and it’s important that we remain vigilant to send the message that small business can and should be protected against any fees or burdensome regulatory paperwork requirements.

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25 Comments

  1. Patricia says

    Thanks, Becky! I have a bunch of heart-shaped molds in several sizes; many of them would work well for individual scrubs or soap samples. And it looks like the other one is a 4-cavity 4-inch square that would then be cut into 1-inch squares. No offense, but I’m in love with my little “1-inchers!” I used them today to make some bath bombs and I found that I had a 1″ x 1″ meat tenderizer hammer that fit perfectly into each little square and gave them a geometric waffle pattern. I hammered the meat tenderizer hammer with another hammer…lol. They look kind of like those strawberry sugar wafer cookies (I think that’s what they’re called)…only square cubes.

  2. Patricia says

    Whew! It sure takes me a long time to get back here! I’ll just address all your replies here.

    Katie’s website, Sterling’s Minerals, is awesome! I happened to click her name (above) earlier and checked out her site before reading the link you sent to me to your fantastic post about “Parabens, Cancer & Experts,” where you had also posted a link to Katie’s excellent blog post on this matter. It appears she has done her homework, and I would feel confident in buying her products. She echos some of the comments I have made here.

    I’ve read that some parabens are present in nature & that methylparaben is found in blueberries. Other natural chemicals with estrogenic activity are found in onions, garlic, cabbage, cashews, grapefruit, hops and American ginseng.

    Here’s an article you might find interesting…

    http://scienceblog.cancerresearchuk.org/2007/09/03/how-to-write-a-good-scare-story/

    Very true – more laws won’t fix the current problems. The current problems can be easily fixed by understanding the current laws. The body care business is a fun business that allows for one’s own creative expression, but production is only one aspect of it. You could make the best products in the world, but poor financial management or bad marketing will cause a business to fail. One must be good at all three to succeed. What is it – most businesses fail in the first 3 years? Think that’s it.

    Thanks for the link to the Handmade Cosmetics Alliance. I think that link may be in my favorites list on my old computer & I’ve forgotten about it. They state there are over 250,000 handmade cosmetic companies. That’s quite a bit more than Debbie May’s estimate, unless she was only referring to those who only sell soap.

    One of the issues I was just reminded of while at the HCA site that I don’t completely understand:

    “Exempt small manufacturers that meet the microbusiness definition from facility registration to a publicly accessible FDA database. With most handmade cosmetic companies operating from a personal residence or in a separate structure located adjacent to the business owner’s home, registering the address presents serious safety issues for the owner and their families.”

    I’ve seen you mention this issue in one of your older posts, but what I don’t get is “why this exemption,” since a manufacturer’s full business address is required on all cosmetic labels, unless such business is listed in a local printed phone directory, in which case only the street address may be omitted, but not the city, state and zip. Many company addresses can be found on their websites or at “Whois.” As such, this info is already public knowledge. What am I missing here?

    As I mentioned before, that massage bar label didn’t have a business address on it, only the web address, which is not required, but “may” be on the label. Nor did it have a batch number. Nor does she list ingredients by INCI name on the label or website. I am more than happy to give anyone the benefit of doubt, but seeing her label and after viewing her site, my doubt flew out the window when I saw so many mistakes. But like you said, I believe it’s a matter of not knowing the law rather than purposely disobeying it. At least when it comes to the little guys.

    Nope…did not do a complete read-through. After looking at the chances of passing and reviewing who would have to register and the associated fees, it kind of seemed pointless at this time. But I do appreciate the fact that you keep us informed. I’ll go back and read the whole thing when I have more time.

    I don’t remember whether it was in one of Gale’s books or where I read it, but the FDA considers the word “balm” to be something soothing or healing, thus a drug, be it OTC or prescribed. I read that lipstick is a cosmetic, (duh,) but lip balm is a drug. It kind of shocked me at first since it seems so many people sell a product called “lip balm.” (***Scroll up and see righthand sidebar – “Make your own lip balm”. What’s up with that? Just don’t sell it?) =)

    But if a balm is truly a drug, then there should be an “active ingredient” in it at a percentage high enough to be considered a drug. So if someone is going to make a moisturizing, yet colorless/semi-colorless product for the lips, they should call it something other than a lip balm, like “Lip Lube” or something along those lines, even if it has a bit of an active ingredient in it….unless they fully intend to be a drug producer and follow the FDA’s very strict requirements for such….at which point they should have the right percentage and be subjected to testing. Otherwise, they’ve misbranded it as a drug simply by calling it a balm, when there’s no, (or not enough,) active ingredient in it to make it so. At least that’s the way I understand it.

    I’m glad we’ve had this discussion. It’s my sincere hope that more producers will read it for the safety of their customers as well as protecting their business from complaint letters sent to the FDA or worse, a potential lawsuit. You’ve added lots of good info and links.

    Oh! I’ve been meaning to tell you! I stumbled upon the cutest ever silicone molds, perfect for the solid sugar scrub cubes you’ve made! (I can think of other uses as well!) You know your 25-cavity cube molds? Just like that, only 9-cavities that are just a smidge over 1″x1″x1″. Found them at a local Macy’s store. They’re actually ice cube trays, of course, but they’re soooo darn cute! Check it out…

    http://www1.macys.com/shop/product/martha-stewart-collection-ice-cube-tray-silicone?ID=701811&PartnerID=LINKSHARE&cm_mmc=LINKSHARE-_-6-_-77-_-MP677&LinkshareID=neQRQBqOKtQ-9A_WkUEdSjz8PrMs4Fvzxg

    All for now. There’s a baby on the way!! Hoping all goes well!

    • Susan says

      Can you point me in the right direction of a the FDA R&R and GMP definitions of ‘Cosmetic’ and ‘Drug’?
      I’m just starting to scratch the surface of what it would take to get started selling my hobby products instead of just giving them out to friends and family. I know enough to know…that I don’t know nearly enough to do this right.
      A book is great, but a lot of printed information is obsolete before it’s even published. I’m not sure that’s the case here, but how do I know? Is there a section of the FDA website that publishes regulations?

      • Patricia says

        Thanks for asking. I somehow feel like the Lone Ranger, though I don’t want that job. =)

        I see Anne-Marie has beat me to the punch. Everything you need to know is there.

        The key is “intended use” in determining whether it is a cosmetic or a drug, (or even a soap,) which is to be determined by the percentage of an active ingredient you use. You may be putting zinc oxide in a lotion, but not at a percentage high enough to make it a sunscreen which is classified as a drug and labeled as the active ingredient. Title 21 shows such percentages. You’ll find it when you review the links A-M listed. If you’re just starting out, I wouldn’t even think about drug production. Your kitchen won’t measure up to the GMP to make such products. I know mine surely doesn’t.

        As law is an ever-evolving thing it is true that it can become outdated. But like A-M has stated, there have been no recent changes.

        But should there be, you can also subscribe to Ms. Gale’s newsletter to get updates via e-mail at http://www.mariegale.com/ If I remember correctly, since I’ve owned them I’ve received only one correction (not an update,) to the first book she wrote….”Soap & Cosmetic Labeling.”

        I believe Bramble Berry sells both books and I highly recommend them. Since laws can get so convoluted, it makes for easier reading. I only wish she had put the actual citations of where the info can be found, but that’s just me.

        All the best to you!

  3. Patricia says

    I always wonder how many soap makers actually know that soap production is not under the R&R of the FDA – UNTIL they make a COSMETIC CLAIM on it, i.e., advertising in any way, anywhere (actual label or ANY form of advertising) stating something like, “This soap is moisturizing,” or “helps prevent wrinkles,” or “deodorizing,” or using their buyer’s testimonies as advertising for making claims of the same nature. Worse yet are the DRUG CLAIMS, as in “Eczema Soap,” or “This soap is good for psoriasis.” I see these claims made ALL THE TIME on nearly every website and in social media forums. ALL. THE. TIME.

    Soap is a consumable, wash off product, ordinarily used daily, and the selling & labeling (all advertising) of it is under the jurisdiction of the Federal Trade Commission and need only comply with the Fair Packaging & Labeling Act, which is comparatively simple in relation to the requirements of the FDA. IF you make no other claim than it “cleans” or “cleanses.” As far as the FDA is concerned, that’s all a soap does.

    But once a cosmetic or drug claim is made on a soap, (advertised as,) or if someone is actually making cosmetics or drugs, a producer is then subject to (or should be,) all the R&R and GMP (Good Manufacturing Practices) set forth by the FDA, a far more complex and higher standard, with registering your company, product testing and so on. Think squeaky clean laboratory conditions if you claim your soap helps with acne or any other skin condition. And be aware of the penalties of misbranding or adulterated products.

    What really scares me is the self-regulatory nature of the cosmetics industry. So far, it is a fairly unregulated industry, since registering and testing is still voluntary, not mandatory. So anyone can make a cosmetic under what the FDA & GMP would consider “filthy conditions.” I’ve seen videos of people making lotions in their kitchens with pets running around in the background. Think that meets the GMP? Hardly.

    But if that little hair-like thingie in your lotion gets reported, be prepared for a nasty little warning letter from the FDA, if not more. Like fines. Like cease as desist operations.

    How many small-scale body care producers even know that a bath bomb is a cosmetic or…get this…that lip balm is considered a drug? Are they making these under the strict guidelines of the GMP for drug production? Are they voluntarily submitting their lip balms for testing? Are they registered with the FDA?

    So if there are increases in regulations and fees, it is precisely to clean up the cosmetic industry, and in particular those small businesses that haven’t a clue as to what they’re doing.

    And yes, you have a stake in that. You don’t sell to the Revlons or the L’Oreals of the world who more than likely know and abide by the rules. But you do put out tutorials on lip balms and the like. I know too, that you’ve recommended Marie Gale’s excellent books, but I wonder how many have actually purchased them. Sadly, from what I’ve seen on the internet, very few.

    So to me, a product should stand or fall not based just on the quality of the product, but also on the integrity of the producer. In other words, are they playing by the rules? Would that not be the goal of the FDA? Is that what these pending new rules and regs are meant to ensure? As a stakeholder in this, I would think it a great idea to bring everyone up to speed on the current expectations of the FDA, for the benefit and protection of both producers and consumers alike.

    Off my cosmetic box now…

    • says

      Currently, we work extremely hard to educate the industry (our customers and others) about Good Manufacturing Practices, proper labeling, making medical claims and a wide variety of other issues around manufacturing safe, fully tested products. This blog has been writing about those very issues for almost 7 years now (and will continue to do so). While there are always some bad apples in every industry (you name it – food producers, medical clinics, gardeners, clothing manufacturers) who will always shortcut and the bath and body industry is no exception, in order to grow your company, you will have to follow GMP, appropriate labeling etc… If you’re making one-off batches in unsanitary conditions or mislabeling your products or making outlandish claims, you won’t have return customers. Products that don’t perform as advertised, or grow mold, or aren’t the same from batch to batch put off any customer! =) Any issues that happen right now in the bath and body industry (say, the Brazilian Blowout debacle for example) are generally covered under ‘existing’ law. In this case, I would urge you to read the currently proposed legislation out there and make up your own opinion on if it will help improve our industry. I have a strong personal opinion that you cannot legislate morality, and you cannot legislate people obeying the law. What we can continue to do is encourage, teach and mentor everyone equally to help our entire cottage industry produce the best, most safe, and most consistent products on the marketplace today by educating on GMP, labeling, claims and recipe formulation. Here is a great blog post on lip balms and drug claims: http://blog.mariegale.com/drug-claims-lip-balm/

      • Patricia says

        Sorry I wasn’t able to get back to you sooner.

        Indeed you have worked hard to educate the industry. I’ve read many of your older posts. And I was very pleased to read in one of them that you had included Gale’s 1st book in the “Business in a Box.” Smart move. Even though some posters got a little snarky over the whole concept, I thought it was pretty cool. =)

        I’ve also read Debbie May say there are around 70,000 small body care producers in the U.S. I doubt that most of them have read all your blog posts, or hers, or Indie Beauty’s, or many other suppliers, or the Guild, or the Saponifier, or Gale’s books. From what I’ve seen, there’s a whole lot of mistakes being made out there.

        It’s always been the goal in every industry to protect small business from over-taxation, (“fees,”) since it hampers innovation. Pretty sure the President and Congress realize that.

        After briefly reviewing SEC 1, Subchapter b, Secs. 611 & 612, I’ve concluded that IF (a big IF,) this bill should pass…

        Both foreign and domestic companies with annual sales receipts of over 2 million will have to register and pay a registration fee.

        Both foreign and domestic companies with annual sales receipts of over 10 million will ALSO have annual fees which will be PRORATED based on the establishment’s gross receipts or sales.

        Given that this applies to both domestic and international bath and body care businesses – a multi-billion dollar industry, that proposed 19 million to be collected through these “user fees,” while sounding exorbitant, is really a mere drop in the bucket when put in perspective.

        The Prognosis is “1% chance of getting past committee.”

        But what I found particularly interesting (or should I say “revealing,”) is…

        “Only 11% of House bills made it past committee and only 3% were enacted in 2011–2013.”

        I’m not going to be sweating bullets over this. As you can see by those numbers, almost nothing gets done in D.C. Only problem is, even if it were to get passed, are the thousands of small body care producers who annually gross less than 2 million can still fly under the radar, many of whom cast a dark shadow on the rest of this handmade industry. Buying from a bad producer makes a potential customer leery of the rest of the community.

        But doesn’t the 3% number sound like a whole lot of useless blowhard chatter with little results? Oh, yes. I forgot. That’s their job. This is what we pay these do-nothing porkers for so they can get a pension equal to their salary, full college scholarships for their kids, extended vacations, and not have to pay into Social Security. Any wonder why we’re ever nearing a fiscal tsunami the likes of which we have never seen? The most immoral among us are our leaders cashing in on the best welfare system ever. (Okay. That was a little rant. Sorry.)

        • says

          You and I agree about the chances of seeing this pass. It’s probably a low chance – but I also felt like I should mention something, just in case. =)

          While I’m not entirely comfortable disclosing numbers of readers for this blog or unique customers that Bramble Berry serves, I can tell you that it is safely over the number (for both) that Debbie has mentioned as the number of small businesses in the US. That doesn’t mean that people choose to follow or understand current labeling requirements just because they read this blog =) but we are trying, and I believe, making a positive dent in education and information. My sincere belief is that people do want to do the right thing.

          There are a lot of mistakes that are made by many small businesses in all industries. It doesn’t make it any less cringe worthy when it happens in ours but to grow, cleaning up labeling, claims, and general business practices is a must. You cannot grow in this industry without doing the ‘right’ thing – which involves following GMP, correct labeling requirements, and have a well-formulated line.

          If you haven’t checked out the Handmade Cosmetics Alliance, this is another clearing source (spearheaded by Debbie May) for information about what’s going on in the possible legislative arm that oversees the FDA: http://www.handmadecosmeticalliance.org/

      • Patricia says

        The second issue…

        “You can’t legislate morality” is apparently coined from the words of Scottish-born sociologist & educator, R.M. MacIver (1882–1970).

        I’d say it’s impossible not to. Every law imposes someone’s moral values on someone else. Those who object to the imposition of moral values should try working to repeal laws like those against such things as murder, perjury, and theft for example.

        What can’t be legislated is the conscience, as you alluded to >>> “you cannot legislate people OBEYING the law.” Clearly, an hour or two of TV news tells us there’s still a lot of violators out there.

        But as I began my original post, I think when it pertains to us little guys, it’s more a matter of not knowing the law, as opposed to flagrantly disobeying it.

        As an example….my friend was given an early birthday gift from another friend of hers who’d recently been on vacation in another part of the state. Among other things was a massage bar. On the label was only a web address (which showed the business had two stores in relatively close proximity,) a description, “Cocoa Butter blended with blackberries and tangerines,” and no weight listed. So I go to the website and it lists the ingredients as “pure cocoa butter, black raspberry & tangerine fragrance oil.? See the difference?
        What if my friend was allergic to FO’s? What if, on the rare chance, she didn’t have access to the internet? I won’t go into the other mistakes I found on the site.

        I don’t see this as a moral failing, just an ignorance of the law. And this owner has already established TWO retail stores? Apparently, the business is thriving.

        There’s another famous old legal
        principle. “Ignorance of the law is no excuse” (for breaking it), wherein, even if you don’t know that something is against the law, you can still be punished for doing it.

        This lack of knowledge is what seems to be most rampant. I think the hype belongs, for the most part, to the larger companies. Perhaps that’s how they got there. People still buy the hype, especially common where the word “natural” is used.

        I’ve recently read about the hype surrounding the use of parabens, written by a bio-chemist PhD working in this field. She stated that someone did a study, wrote a paper, it caught on like wildfire, yet there are no other studies in all the scientific journals to back it up.

        • says

          Legislating conscience; legislating morality. It boils down to semantics for me. What I was trying to say is that you cannot force people to do the right thing, no matter what the consequences are. Driving drunk is something really nice, normally law-abiding people do and the consequences are reallllly high for that offense. Name a crime or a law, and there will always be a subset that ignore the rules for whatever reason, no matter what the stakes are.

          Regarding what happened to your friend and the labeling issue. That is super lame and yes, could have been dangerous. I’m glad it wasn’t. I’ve seen that issue too and it drives me bonkers. And maybe you’re right that it was straight ignorance of the law. Or maybe it was any number of other reason. Maybe it’s that she was busy and had too many labels printed and was trying to use them up. Maybe she put on an old label in the fog of tiredness. It’s tough to say what happened there but there’s lots of explanations for what could have happened and you and I will be scratching our heads on that for a while.

          What I do know is that if someone is deliberating not following the law currently, is that more regulation won’t necessarily fix that issue.

          There are a variety of additional provisions in the SCA that you may have seen during your read through – reporting incidental ingredients (no matter how incidental), reporting full fragrance ingredient disclosure, contaminant declaration, website ingredient declaration. None of those issues solve the main justification I often hear for why the industry needs more regulation: “So and so isn’t following the law now.” If someone isn’t following the labeling laws that are out there now, they are breaking existing law. Adding more laws or red tape on top of it won’t solve that issue.

          Side note: Totally agree with your assessment of the parabens issue. Here’s a blog post on it that you might find interesting: http://www.soapqueen.com/bath-and-body-tutorials/lotion/parabens-cancer-experts-2/

    • says

      Good morning, Jennifer!

      We are so grateful to Anne-Marie for staying on top of these different legislative issues concerning the cosmetics and handmade craft industries. Make sure to keep following the Soap Queen blog for more updates on this and other legal issues. =)

      -Becky with Bramble Berry

  4. Jennifer says

    I hope everything turns out well… I envy(healthily) the ease and support for small and indi business there… the cosmetic insdustry is so tightly controlled here in Europe/ Spain… and you put it so nicley “burdensome regulatory paperwork requirements” can get me down sometimes and take up a lot of time. With all of the requirements for sanitary products and cosmetics here, I feel like they churn out clones… and the little guy, doing his own thing gets lost or can’t really operate legally. I know there are a lot of people fighting to keep things on track there so go for it!! xo Jen

    • says

      Ah, yes – and the thing that I also wonder about the EU requirements is how many people just go into other industries that are less regulated. For example, if it’s cheaper and less burdensome to go into another industry, some people will take that easier route – even if it’s not their passion and even if they could make a positive difference in their industry. I’ve heard nightmares about the EU system with regards to the paperwork but this is the first time I’ve read the insight about having a lack of choice in the marketplace because of the regulations. That’s great insight. Thanks for posting.

    • says

      Hi Amanda!

      We are so happy that Anne-Marie has stayed on top of this and is constantly working towards better legislation for small-business owners and soapcrafters. We can’t thank her enough for all the work she does! Keep watching the blog for more updates. =)

      -Becky with Bramble Berry

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