On Wednesday evenings from 8 to 8:30pm ET, I host #MakerBizChat, an Instagram event to help Makers and Handmade Entrepreneurs build a solid business foundation, increase your income, and use your business to create the life you love. Our topic last night was 10 Facts to Know Abut the Personal Care Products Safety Act of 2015, and I posted a useful list of things every cosmetics Maker needs to know about the newly introduced piece of legislation.
As I mentioned at #MakerBizChat last night, this is not an exhaustive discussion of the bill, and I am not providing legal advice here. I am sharing information to inform you and provide guidance you can use to learn more on your own. You can read the entire discussion on Instagram at this link. Because Instagram is specifically geared toward mobile, you will be able to view all of the discussion on a mobile device, but only part of it from your laptop or computer. Here is a overview.
FACT NO. 1: COSMETICS ARE REGULATED, AND HAVE BEEN FOR DECADES
Cosmetics have been regulated by the Food & Drug Administration since 1938 when the Food, Drug & Cosmetic Act became law. If you are not familiar with existing laws and regulations, you can find them in the Cosmetics area of the FDA's website.
If you make and sell cosmetics, the federal laws apply to you.
PCPSA as currently drafted does not change the current definition of a “cosmetic,” which is defined as “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.”
Since 2008, several pieces of new cosmetics legislation have been introduced. Each has either never made it to a committee or has died or become inactive in committee. You can get a full view of the history by reading the posts in the Law and Advocacy Category of this blog, where my post go back to June 24, 2008. PCPSA, the bill under consideration now, is just a bill and is undergoing consideration and discussion as we speak. It is NOT the law at this time. It is under consideration, and would change federal cosmetics laws in several ways.
Advocacy groups on both sides of the issue are currently working with legislators and their staffers to argue their various points. This is a fluid process which will continue until the bill either dies or become law. For now, continue to follow current law, but know what may be coming down the pike.
FACT NO. 2: SOME STATES HAVE THEIR OWN COSMETICS LAWS
A few states have very specific cosmetics laws, among them Florida and California. If you make cosmetics and/or sell cosmetics in those states, you must follow the federal laws and also the laws of those states. (In the past, other states have considered new cosmetics laws of their own, including Colorado and Massachusetts, but those bills have not become law.)
FACT NO. 3: REGISTRATION
PCPSA includes a provision requiring everyone who makes and sells cosmetics to register with FDA. This includes registering your company and products and ingredients in them. Currently, registration is voluntary under FDA's Voluntary Cosmetic Registration Program. If you make cosmetics from home, you would have to register under PCPSA, but your address will not be made public.
FACT NO. 4: FEES
PCPSA includes a provision requiring everyone who makes and sells cosmetics to pay an annual fee to the FDA. The annual fee is $250 if you gross between $500,000 and $2.5Million per year (averaging the past three years). You would not have to pay a fee if you gross less than $500,000 per year, (averaging the past three years).
FACT NO. 5: GOOD MANUFACTURING PRACTICES (GMP)
PCPSA requires FDA to create mandatory Good Manufacturing Practices (GMP). If the bill in its current form becomes law, small businesses (not yet defined) would have two years to implement GMP. Larger companies would have to do it faster. At present, GMP is more a “guideline” than a law. (Though that is a generalization.) You can find the current GMP guidelines at FDA's website at this link.
FACT NO. 6: SERIOUS ADVERSE EVENTS
PCPSA requires manufacturers to report serious adverse events with regard to their products, such as a threat to life, death or any persistent or significant disability or incapacity, within 15 days. If you have no adverse events, you'll state that in your annual registration filing, and if you have adverse events that are not so serious, they'd have to be reported as well.
FACT NO. 7: COSMETIC INGREDIENT STATEMENTS
PCPSA would require submission to FDA of a cosmetic ingredient statement for each cosmetic you make, within 60 days of the product going to market, and the statement would indicate that the product is safe. It's not clear yet exactly how that substantiation would need to be made. You would have longer than 60 days after introduction of a product to submit the statement if you are defined by FDA as a “small business,” but the legislation leaves that definition to FDA's later discretion, based on the Small Business Act's definition of small business.
FACT NO. 8: INGREDIENT REVIEW
Under PCPSA, FDA would be required to review at least 5 ingredients per year for safety, and make their findings public after time for public comment.
FACT NO. 9: PREEMPTION
The bill says that states that do not now (or at the time the bill as drafted becomes law, if it does become law) have laws about registration, GMP, recalls, or adverse event reporting, cannot pass such laws. (It's not clear whether states can pass their own labeling laws under this provision.)
FACT NO. 10: SUCCESS CALL TOMORROW
I will host a Success Call on Friday, May 1, 2015 at 12pm ET to further discuss the legislation.
My guest for that call will be our member, Anne-Marie Faiola who leads the Coalition for Handcrafted Entrepreneurs and who is working with a lobbyist to advocate for small businesses regarding this bill. The call is open to the public and will include tips on how you can proactively and positively participate in the advocacy process as a small beauty business owner. I encourage you to register to attend.
If you are an IBN member, you do not have to register as the call information has been emailed to you and posted in our Secret Facebook Group.
When Is The Next #MakerBizChat?
The next #MakerBizChat will be Wednesday, May 6, 2015, at 8pm ET.
Our guest will be Caitlin Bacher of Little Farm Media, and our topic will be How To Use Instagram To Tell Your Brand Story.
#MakerBizChat takes place Wednesday evenings at 8pm ET on Instagram. Be sure to follow so you can catch all of the questions and participate in the live and lively discussion.