Personal Care Products Safety Act (2015)

On April 20th, 2015, Senators Diane Feinstein (D – CA) and Susan Collins (R – ME) introduced The Personal Care Products Safety Act (S. 1014), which, if passed, will update the Food, Drug and Cosmetic Act as it pertains to cosmetics.

There has been considerable discussion about various aspects of the bill and what its effects will be. Several people have asked me for my take on the bill, so I’ve gone through the bill in detail . (What a process!) My comments about it and what it might mean are detailed below.

Please remember, these comments are my personal opinions and are based solely and only on my understanding of the existing laws and regulations and how this bill could, potentially, change those laws and regulations.

Additionally, since I am most familiar with the handcrafted soap and cosmetic industry my view is from that perspective. Those who are in the “big business” realm of cosmetic manufacturing will probably have a different take on some aspects of the bill.

Chances of Success

First off, before getting worried and upset, it’s important to keep in mind how the legislative process works and what chances this bill has of making it through all the steps and becoming law. Let’s take a look at some of the factors:

The process for the bill (somewhat simplified) is that it must get through committee (all previous similar bills have failed at that point), then it has to get passed by the Senate, passed by the House and signed into law by the President. So there are a minimum of three points at which it is voted on and must pass by a majority vote. At each of those steps there is a possibility of amendment to the text.

The Senator who introduced the bill is a Democrat. Granted, she has some legislative history and political clout, but she is working in a Republican-controlled Senate. The bill will also have to make it through a Republican-controlled House.

There was only one co-sponsor (Republican Susan Collins from Maine) when the bill was introduced. Since then two new co-sponsors have signed on; Barbara Boxer (D-CA) and Amy Klobuchar (D-MN). Previous bills had numerous sponsors, but they still failed.

Govtrack.us, which monitors all pending legislation, gives the bill only a 3% chance of passing. You can track the bill here.

What the Bill Addresses

The intent of the bill is to “ensure the safety of cosmetics.” To do so, it amends the Food, Drug and Cosmetic Act; mostly the cosmetic section, but bits and pieces elsewhere in the Act as well. This bill is similar to those that have been introduced in the past, with focus on registration, GMP, ingredient safety, adverse reactions and funding to the FDA.

Honestly, if I didn’t know anything about the handcrafted soap and cosmetic industry, I’d probably look at the bill and go, “Hey, that looks great! Cosmetics should definitely be safe. The FDA should make sure that any dangerous ingredients are banned and know who is making what products. If something is going to kill someone, then the FDA should be able to require the product is recalled. Wait!… couldn’t they do that before?” (No, by the way.)

So, since I DO know something about the handcrafted soap and cosmetic industry, I look at the bill and think, “I got into making soap and cosmetics because I wanted better, more natural products to use. Putting all those regulations in place may be a way to get some control on what the big cosmetic companies are doing, but applying those same levels of control to handcrafters could be devastating.”

Some provisions have been made for small businesses, which would cover some (but not all) handcrafted soap and cosmetic businesses. I believe many of these provisions are the result of the advocacy work of the Handcrafted Soap and Cosmetic Guild. I agree with the HSCG’s stance that there are insufficient protections of small business as the bill is currently worded.

This bill applies to COSMETICS. It does not apply to soap that is exempt from the definition of a cosmetic. It also does not apply to candles or home fragrance products.

Breaking it Down

Now let’s break down what the bill covers and what it might mean. I’ve put the more applicable points first, even though they come later in the bill.

Keep in mind, once again, that the liklihood of the bill passing is slim. Also, many of the provisions of the bill are fairly general and the FDA will have to put detailed regulations in place, and that process gives multiple opportunities for input and comment.

I apologize in advance for the length of this post; at 98 pages, there is a lot of information in the bill!

1. Labeling Changes

There are a couple of labeling changes included in the bill; none of them are very substantial. They would go info effect one year after the bill is enacted. There would probably also be additional FDA regulations created to cover the requirements in more details, which will take months or years to get into place (and I would have to update my Labeling book again).

a. Contact Information

The telephone number or electronic contact information (both are encouraged) would be required on the label. That shouldn’t be an issue for most people. If there are privacy concerns, a separate phone number and/or email could be used.

Consumers should be able to report adverse events and get additional information about cosmetic ingredients. As a sort of odd inclusion (there must be some reason for it), the consumer must be able to ask if a specific ingredient is in the product that is not listed on the label (huh?) or if it is in a fragrance or flavor used in the cosmetic. The manufacturer has to be able to get that information to the consumer and the supplier (of the flavor or fragrance) is required to release the information to the manufacturer.

b. Safety Labeling

Part of the bill includes the FDA review of ingredients and their determination of the ingredients’ safety (see #6 below). In the event that an ingredient is determined to be unsafe for children, pregnant women, or other vulnerable populations, the label must include an appropriate warning.

I assume that these warnings would be similar to the existing warnings that are required on cosmetics under some circumstances (such as the bubble bath warning and warning for tanning lotion without sunscreen). For the most part, I hope that those making handcrafted cosmetics are not using ingredients that are determined, through real science, to be unsafe for children or pregnant women, or anyone else for that matter.

c. Products for Professional Use

The bill includes special labeling for products for professional use and defines what qualifies as professional use. Ingredient lists are required, and if the product contains an ingredient or a concentration of an ingredient that requires safe handling by trained professionals, the product would require a notice.

My guess is that this is for products like professional hair bleach or dyes or the stuff that was in the Brazillian Blow-out hair products that caused so much trouble. I sincerely doubt that any handcrafter will produce products that fall into this category.

2. Internet Sales

The bill requires that an internet website offering cosmetic products for sale to consumers must provide the same information that is required on the label. In other words, the identity of the product, the net contents, the ingredients, and any required warnings, along with the directions for safe use, and any other material facts.

This might be an issue for internet websites that are selling cosmetic products from multiple manufacturers, but I would assume that most people who are selling their own products already have most of this information on their website. It’s good marketing!

There don’t appear to be any exemptions, so if the bill passes, the information will be required on all websites across the boards.

3. Facility Registration

Facilities that make cosmetics will need to register with the FDA. The information will be public, excepting residential addresses will be kept private.

Businesses that make LESS than $100,000 in cosmetic sales annually are exempt. In my opinion, in order to protect the industry, this exemption should be higher. Sales over $100,000 may sound high, but it’s a DROP in the bucket of overall cosmetic sales. At that level a business making handcrafted cosmetics is just beginning to get into a new realm; added administrative and financial burdens could be devastating.

However, keep in mind that this is in cosmetic sales annually and does NOT include revenue from candles, household products, or soap that is exempt from the definition of a cosmetic.

Over $100,000 in annual cosmetic sales, the facility must register, but there is no fee until the annual cosmetic income averages more than $500,000 for the previous three years, at which time the fee is $250.

Above that, there’s a gradient scale that goes from $500 when the cosmetic income is $2.5 million per year, to a fee of $1.1 million (yes, million) if the gross annual sales are $5 billion (yes, billion, with a “b”) or more. Luckily, at that level, it’s definitely outside the realm of “handcrafted.”

4. Product Registration

Cosmetic products will need to be registered with the FDA. The product registration must include the ingredients, but the bill allows for a range of possible amounts of each ingredient, and a “list of fragrances, flavors, and colors that may be included in the product interchangeably.”

I expect that the range of possible amounts is to keep exact cosmetic formulations secret, and it’s similar to the way it is for patents and akin to how it is handled in other countries, I think. The list of interchangeable fragrance, flavors, and colors means that you could have a line of lotions that come in 20 different fragrances and/or colors, and you’d only have one product listing. Of course, you’d have to determine in advance what those fragrances and colors would be.

Again, businesses that make LESS than $100,000 in cosmetic sales annually are exempt.

For small businesses, the bill allows that the FDA may create simplified ingredients statements for businesses that have to register their products, but have a 3-year average annual gross revenue in cosmetic sales of under $500,000.

5. Safety of Finished Cosmetic Products

Generally, each “responsible person” must make a written determination that the product is safe under the conditions of use recommended in the labeling of the product. The determination of safety should be based on the safety of the individual ingredients in the product and of the finished product.

By the definition of “responsible person” in the bill, businesses that make LESS than $100,000 in cosmetic sales annually are exempt.

The FDA is required to issue guidance describing the evidence necessary to determine safety, and may establish exemptions to the requirements if they are supported by adequate evidence and would have no adverse effect on public health.

In addition, the FDA is required to issue more guidance for small businesses, which should include specific examples of options for compliance that do not place an undue burden on small businesses.

If the bill passes, it remains to be seen what the FDA would consider as appropriate “evidence” of the safety of a cosmetic. For those small businesses that make more than $100,000 in annual cosmetic revenue, but not much more, this part of the bill could be a problem. It really depends on how the FDA approaches the issue, how they assess the effect on public health, what they determine to be “adequate evidence,” what they consider “undue burden” on small business, and what exemptions they end up allowing in regulation.

The final regulations and guidances will take several years to get in place and there will be many opportunities to participate in the process.

Quite aside from the legislation and any regulations, if you are making cosmetic products you should at least have some idea that they are safe, and why. If you haven’t already, you should honestly review your formulations, document them in detail, and write out your view on why they are safe (your ingredients, preservative system, etc.). Collecting documentation on the safety of your ingredients—even if they are “generally regarded as safe” food items—is also a good idea (and part of good manufacturing practices).

6. Preemption

The bill includes a provision for preemption, applied to registration, good manufacturing practices (see #7 below), adverse event reporting (see #9 below), and recalls (see #10 below). In other words, it says that the states can’t create laws or regulations that are different from the federal laws. There are a few exceptions, as in the case where there is already an existing and implemented law in place.

I’m not sure how the various states will react to this. Maybe they will think it’s a good thing and they won’t have to worry about all the different aspects of registration, GMP, recalls, and adverse event reporting; maybe they won’t like the fact that the federal government is telling them what to do.

In any event, it would make things easier all around, especially since some of the states are considering their own registration processes.

7. Good Manufacturing Practices for Cosmetics

If this bill is passed, the FDA will propose regulations for good manufacturing practices for cosmetics. The Cosmetic GMP regulations will be in accordance with national and international standards “as the FDA determines practicable and appropriate.” The FDA has 18 months to issue a proposed rule, and 3 years to issue final rules; rules will take effect for small businesses 2 years after that.

The international standards for good manufacturing practices are issued in ISO 22716 Standard, Good Manufacturing Practices for Cosmetic Manufacturing (available for about $125 from the International Standards Organization).

My book, Good Manufacturing Practices for Soap and Cosmetic Handcrafters, covers ways in which handcrafters can adapt the basics of GMP to their operations. (See Shameless Plug above.)

There don’t appear to be any exemptions for small businesses in this section other than to allow two years before the regulations take effect for small business while big businesses only have 180 days.

In my opinion, if the bill passes (again, unlikely) ensuring that the FDA understands the handcrafted industry and takes our needs into account when promulgating GMP regulations will become extremely important.

8. Review of Ingredients

As part of the bill, the FDA is required to review cosmetic ingredients and “non-functional constituents” to determine their safety in cosmetics. The bill includes a number of provisions about how the review is supposed to take place and establishes a Cosmetic Safety Advisory Committee with members from the industry, consumer groups, and other individuals to advise the FDA on what ingredients should be reviewed, and do other things.

The first ingredients to be reviewed are diazolidinyl urea, lead acetate, methylene glycol/methandeiol formaldehyde, propyl paraben, and quaternium-15. I expect those ingredients were picked because they are the focus of public scrutiny and have been (or are being) regulated in other countries. After that, the FDA is supposed to review five ingredients or non-functional constituents per year. They are allowed several years for each ingredient to go through the review process.

This portion of the bill shouldn’t have any effect on cosmetic handcrafters. In the long run it will be some additional information to keep track of and, for some people, could result in reformulating if an ingredient is determined to be unsafe. But, if that’s the case, you probably want to reformulate anyway!

9. Adverse Event Reports

Most people don’t realize that cosmetic manufacturers are not REQUIRED to report adverse reactions to their products. The FDA requests that they do so, and has a campaign to get the public to report problems, but none of it is required.

This bill requires that cosmetic manufacturers report any “severe adverse event” for a cosmetic product. A severe adverse event is one that results in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, or significant disfigurement. (Yikes!) It goes into detail on how reports are submitted and what should be done with them by both the manufacturer and the FDA.

Technically, businesses that make LESS than $100,000 in cosmetic sales annually are exempt. However, in my opinion, if you make a cosmetic product—regardless of your annual sales—that results in the hospitalization, disfigurement, or death of a customer, not only should you report it, you should seriously consider a different line of work.

10. Mandatory Recall Authority

Another thing that many people don’t realize is that the FDA has no authority to order a cosmetic company to recall their products. The product could be harming customers, but all the FDA can do is warn the manufacturer about the issue, request they voluntarily recall the product, issue a public warning as a Consumer Alert, or seize the product (where they can).

This bill, if passed, will give the FDA mandatory recall authority. In other words, after they’ve given the manufacturer the opportunity to recall a product that is likely to cause serious adverse health consequences or death and nothing is done about it, the FDA can require them to recall the product. The bill lays out the steps for hearings, notices, and orders.

Again, businesses that make LESS than $100,000 in cosmetic sales annually are exempt. In my opinion, I think the FDA should have the authority to order the mandatory recall of a dangerous cosmetic product.

11. Animal Testing

Lastly, the bill addresses the issue of animal testing by encouraging manufacturers to reduce or eliminate animal testing and requiring the FDA to provide information on other adequate testing options.

My Opinion in Summary

First of all, I wish that this were two different bills: one having to do with the safety of ingredients, adverse reaction reporting and mandatory recalls (which I support); and the other covering everything else (which I generally don’t, at least not without higher exemptions for small business). But, sadly, that’s not the case.

As it is, I feel that even with the relatively decent aspects of the bill, the fact of the low exemption levels for handcrafters means that it could potentially do more harm than good to our industry.

Worst Case Scenario

As I see it, the worst case scenario is that the bill is passed as-is, without higher exemption caps for small businesses.

Less Than $100,000 Annual Cosmetic Revenue

Businesses that gross less than $100,000 in annual cosmetic revenue and intend to stay below that income level will be the least affected. They will still have the costs of changing labeling and updating their websites. The most unpredictable factor is how the FDA will deal with the regulatory implementation of GMP. If the FDA exempts this size business it will not be an issue, but if compliance with full-on GMP regulations is required, it could be devastating to this group of handcrafters.

Between $100,000 to $2 million Annual Cosmetic Revenue

The group who will be most affected will be those who make over $100,000 and less $2 million in cosmetic revenue per year. There are numerous small, small businesses (many still working out of their homes) that fall into this category, particularly those in high density, high cost-of-living urban areas, or that have very successful websites. It only takes selling 200 lotions at $20 each, 500 soaps at $7.50 each and 200 bath bombs at $4.00 each per month to make over $100,000 in annual revenue.

That may sound like a lot to some people, but when a business reaches that level it is still very small and probably very fragile. It is the most difficult time for a business when it is JUST getting to the point of some “decent” profit, but is still struggling with maintaining production, meeting demands, providing for capital improvements, getting new facilities, adding and training staff, and all those things that go into the “transitional” stage of a business.

At this stage, it doesn’t take much to collapse a business; a huge wholesale order gone bad or the burden of additional regulatory costs and administration could do it.

Discouraging Growth

Probably one of the worst results of the bill, in the unlikely event that it is passes as-is, is that it would discourage growth in the handcrafted soap and cosmetic industry.

Best Case Scenario

The provisions in the bill to ensure consumer safety stay intact (serious adverse event reporting, FDA ingredient reviews, mandatory recalls), and the exemptions for small business are sufficiently increased to reduce the burden on small and emerging handcrafted businesses, particularly those that have “made it” and are in that delicate transition stage.

I’m rooting for the HSCG and their legislative advocacy efforts to carry the message to Washington and get the exemptions suitably increased. So far, their actions have served the industry well.

If you’re not a member, I urge you to consider joining the HSCG. Making headway in Washington takes not only time and a deep understanding of the industry, it also takes money to cover the expenses of going there and having meetings, providing materials and paying for an advocate to watch our collective backs. And the only source of funds for those activities comes from our membership dues. Plus, the larger the group, the stronger the voice.

1. Legal Dictionary at thefreedictionary.com ↩︎