This is an expanded version of the article originally posted and removed due to a photo copyright issue. Several people asked it to be replaced, so here you go. I’ve made a couple of edits and additions in response to both the overwhelming concern about S.1014 and comments that it’s nothing to worry about because the bill contains exemptions for people making soap for their families. I am posting a link to the bill and contact details first. If you already read the article, jump down for important (imo) considerations about the nuances of what soap and cosmetics are according to the FDA, along with a few other comments and links.
Bill Information: 4/20/15 Senator Dianne Feinstein (D-California) and Senator Susan Collins (R-Maine), introduced S.1014: A bill to amend the Federal Food, Drug, and Cosmetic Act to ensure the safety of cosmetics. It is referred to as the Personal Care Products Safety Act. Here is a great summary by Modern Soap Making, if you don’t have the stomach for 94 pages of legaleze.
As of 5/6/2015, S.1014 is in the Senate Health, Education, Labor, and Pensions Committee. Committee Chairman Lamar Alexander (R-TN) will determine if it moves past the committee stage. Phone: (202) 224-4944, email: http://www.alexander.senate.gov/public/index.cfm?p=Email.
Click and scroll down here to see who else is on the committee. If one of your senators is there, or a presidential candidate, why not contact them . They love to hear from their constituents.
People who are trying to do good for their families and the planet by living a simple life based on traditional skills are facing yet another assault. The Handmade Cosmetic Alliance says new regulations, proposed by Senator Dianne Feinstein (D-California) and Senator Susan Collins (R-Maine), will put small artisanal soap and cosmetic makers out of business.
The Handmade Cosmetic Alliance posted this form on its website that can be used to reach out to elected representatives.
The form includes a statement on behalf of handmade body care product makers that says, in part:
“My products comply with FDA labeling requirements and the ingredients are commonly known (i.e, olive oil, oatmeal, sugar, coconut oil, etc). My best customers are in my community. I cannot afford the user fees proposed in S. 1014. Further, my business has no capacity to do the reporting requirements for each product batch (10-50 units) as it could be several hundred FDA filings per month.” Those who sell online will also be affected.*
It is fair to mention here, that HCA’s director, Deborah May, also built a kitchen table soap operation into a $10 million business called Wholesale Supplies Plus, that looks to be very much impacted if the bill becomes law.
The view of Sen. Feinstein and her corporate backers (listed below) is that the Personal Care Products Safety Act is necessary to make the world a safer place by scrutinizing “everything from shampoo and hair dye to deodorant and lotion.” She introduced the amendment to the Committee on Health, Education, Labor, and Pensions, because of troubling negative health effects from chemicals used in personal care products. She says the Federal Food, Drug, and Cosmetic Act should be more progressive like laws in Europe rather than antiquated US regulations in effect since the 1930s.
The Personal Care Products Council, which supports S. 1014, provides an article with a different view on cosmetic regulation in Europe, (Kingham and Beirne, of Covington & Burling LLP)
”It is sometimes suggested that cosmetic products are more strictly regulated in the European Union (EU) than in the United States and that the EU system is, for this reason, a better model than its U.S. counterpart. In fact, however, the approach to regulating cosmetics in the EU and the United States is fundamentally the same.”
Problem ingredients Feinstein cites include:
Methylene glycol, (an ingredient in the popular hair smoothing treatment known as the “Brazilian Blowout”) turns into formaldehyde when heated, and exposure has been reported to result in hair loss, rashes, blistered scalps, nosebleeds, bleeding gums, shortness of breath, vomiting and increased risk of cancer.
Propyl paraben, a preservative used in a wide range of products including shampoo, conditioner and lotion, mimics the hormone estrogen and can potentially disrupt the endocrine system and cause reproductive system disorders. She then goes on to say “consumers deserve to know that the products they use every day are safe.”
Huh? She just said they’re not safe, which is why I and many women already choose to spend a few dollars more on natural products. Feinstein does not propose to ban these dangerous ingredients from soaps and cosmetics, just regulate them with tests and warning labels, fees, and recall authority. She thinks some of these products, though harmful to health, magically become “safe when used by professionals in a salon or spa setting.” My question is; after a half century of so called feminism, why are women still knuckling under to industry pressure and voluntarily paying to have these poisons applied to their bodies on a regular basis? But I digress.
If the industries that back this law are really so concerned about safety, why don’t they voluntarily make healthy products, like the small time producers already do?
It sounds like the problem could be more easily solved with an education campaign, and subsidies for the natural soap makers so they could offer their products for less and increase their market share. Why not include them on EBT cards so poor women can buy them — I mean, if you want to really be “progressive,” we need to be able to get them at the Dollar Store.
Other potentially dangerous chemicals Feinstein wants to clamp down on include:
Diazolidinyl Urea, which is used as a preservative in a wide range of products including deodorant, shampoo, conditioner, bubble bath and lotion.
Lead acetate, used as a color additive in hair dyes.
Quaternium-15, a preservative used in a wide range of products including shampoo, shaving cream, skin creams and cleansers.
The new law would require the FDA to review at least five chemicals used in personal care products each year… Wait a minute, isn’t there a revolving door between FDA, industry lobbyists, and Congress? Is this yet another example of bureaucratic job security while the small operator is forced out of business? Remember what happened last year, when the FDA wasted taxpayer (your) money by attacking Dr. Bronner the soap maker, for pointing to a scientific study that said coconut oil is good for you?
Feinstein says her proposal is a “streamlined national system of oversight” and it won’t cost the taxpayer anything because it’s funded by industry user fees (until they pass the extra cost to the consumer, that is). Big multinational soap makers may be able to manage the increased fees and paperwork called for by Senate Bill S.1014 but the the Handmade Cosmetic Alliance says it will cripple cottage industries like those in its association that generally employ 1 – 3 people.
The senator assures the new law encourages public input with many opportunities built in for consumer groups, companies, medical professionals, scientists and the public to weigh in …but according to the Handmade Cosmetic Alliance, they’re already not listening.
“The HCA had several meetings over many months with the sponsor of S. 1014 and presented information to support small business exemptions similar to those the 2011 Food Modernization Safety Act (FSMA). Sadly, a decision was made to use prescription drugs and medical device standards for small handmade cosmetic businesses. This does not make sense. My products are soaps, lotions and scrubs made largely with food-grade ingredients found in any grocery store,” according to the letter provided by HCA, that natural soap makers can send to lawmakers.
Companies and brands that support the bill:
Johnson & Johnson, brands include Neutrogena, Aveeno, Clean & Clear, Lubriderm, Johnson’s baby products.
Procter & Gamble, including Pantene, Head & Shoulders, Clairol, Herbal Essences, Secret, Dolce & Gabbana, Gucci, Ivory, CoverGirl, Olay, Sebastian Professional, Vidal Sassoon.
Revlon, brands include Revlon, Almay, Mitchum
Esteee Lauder, brands include Esteee Lauder, Clinique, Origins, Tommy Hilfiger, MAC, La Mer, Bobbi Brown, Donna Karan, Aveda, Michael Kors.
Unilever, brands include Dove, Tresemme, Lever, St. Ives, Noxzema, Nexxus, Pond’s, Suave, Sunsilk, Vaseline, Degree.
L’Oreeal, brands include L’Oreeal Paris, Lancome, Giorgio Armani, Yves Saint Laurent, Kiehl’s, Essie, Garnier, Maybelline-New York, Vichy, La Roche-Posay, The Body Shop, Redken.
Additional Comments
Some people are saying S.1014 will have no impact on cottage industries that make natural soap. The main reasons stated are that soap is not regulated by the FDA and that small producers are excluded. Others say FDA regulation is good when it comes to anything but the smallest businesses. Lets address those from last to first. Disclaimer: These are my opinions. There are lots of links on this page for you to investigate further and reach out to others in the natural soap and cosmetic community.
Can FDA Be Trusted?
Are there harmful ingredients in commercial cosmetics? According to the bill’s sponsors, yes. But the idea that government will make things right with more regulations is a pipe dream. For one thing, FDA gets funding from big businesses it regulates, and they can afford to ignore the rules while the little guy is a vulnerable target. Watch this documentary called “War on Health – the FDA’s Cult of Tyranny (2hrs) for some revealing conflicts of interest.
Does S.1014 Impact Your Small Business?
The proposed amendment says any facility that grosses more than $100K a year has to register, but only those making more than $500k have to pay a fee. While $100k exempts some producers, $100k gross is not unusual for a family business run from home. If half is the pretax net spread among three or more people, they are barely making a livable wage. Even if your natural products business doesn’t make that much now, you might be wanting to build your business. And, if you want to get together with a few other soap makers, in a guild, for example, and share production or storage space, the $100k applies to the facility overall, not the individual businesses, the way I read it.
Online Sales?
The bill says websites of ALL personal care products sold online must include information that is on the label. Does it really mean ALL, or just those who sell more than $100k?
*”As more consumers choose to shop online, it is of growing importance that they have access to the same product information they would see in a store. This bill requires all personal care products sold online to include information that is on the label. Consumers will be able to see all ingredients listed, along with any product warnings and other important information on use.”
What Exactly is Soap?
It depends on what you mean by soap. FDA has a very narrow definition of soap. If you make small amounts of soap from animal fat, vegetable, or mineral oil and lye, and nothing else, things may be okay. But when you get into FDAs finer definitions of soap versus cosmetics, you may want to consult a legal expert.
Soaps/Cosmetics/Drugs
In FDAs view, the line between soap, cosmetics, or drugs can be easily misconstrued. Cosmetics may really be drugs in FDAs thinking, and soaps may be cosmetics. It depends on several factors: the ingredients, the purpose of the product as stated either on the label or during marketing, and consumers’ perceptions and expectations. As a producer, your life can drastically change on a turn of phrase.
According to FDA.gov, the agency considers a product soap if it consists primarily of alkali salts of fatty acids and is intended only for cleansing. However, if there is an intention to make the user more attractive by imparting fragrance, acting as a deodorant, or moisturizing the skin, for example, it becomes a cosmetic and is regulated as such, even though it may legally be labeled soap. FDA says hardly anybody makes plain old fashioned soap anymore.
Cosmetics are “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)]. Any body care product that is not soap in the strict sense of the word, is regulated as a cosmetic or drug. Natural products made by home based producers may include: moisturizers, balms, salves, shampoos, deodorants, and massage oils. FDA classified them as either cosmetics or drugs, depending on the intent behind them. For example, if you bottle a natural oil and add a scent for massage oil, it’s a cosmetic if you intended to lubricate the skin and emit a pleasant odor. The moment a claim is made that it helps relieve soreness, it becomes a drug and different regulations kick in. That video linked above addresses the issue further.
But It’s Organic!
When it comes to safety, FDA does not distinguish between ingredients like methelyne glycol or propyl paraben and those that are natural and/or organic:
“An ingredient’s source does not determine its safety. For example, many plants, whether or not they are organically grown, contain substances that may be toxic or allergenic…Under the FD&C Act, all cosmetic products and ingredients are subject to the same safety requirement…”
The trend is to assume a thing isn’t affecting you because you are not seeing a direct threat to your own life, so no worries. Even if you make “soap” by FDA standards, not “cosmetic” soap or other body care products, this law can impact you if you buy healthy body care products from other small producers.
Resources
http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm
http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074201.htm#Definecosmetic
http://www.fda.gov/Cosmetics/GuidanceRegulation/LawsRegulations/ucm074248.htm
http://www.fda.gov/Cosmetics/Labeling/Claims/ucm203078.htm
http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5068442
Sen. Feinstein’s introductory remarks S. 1014 [Congressional Record Volume 161, Number 57 (Monday, April 20, 2015)] [Senate] [Pages S2274-S2275] From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]
Soap photo courtesy of Sozo Artisan Soaps
Thanks to everybody else who offered soap pics. They are buried in the avalanche of comments and emails at the moment. If you’d like me to include an image if I do a follow up, please re-msg.
Filed under: Backwoods Self-Reliance Skills, Current Events & Signs of the Times, Simple Living Tagged: cosmetics, FDA, fda requirements, government regulations, Handmade Cosmetic Alliance, handmade cosmetics, Personal Care Products Safety Act, regulations, S104, Simple living, soap, soap makers 
