When I started my apothecary brand way back in 2003, I had precious little clue about what I was doing. I’d never heard of “GMP” (good manufacturing practices) for cosmetic companies. I understood that personal care brands in the U.S. were beholden to the Food & Drug Administration (FDA), and I was aware of the specific rules surrounding product labeling, but manufacturing protocols weren’t a primary area of focus for me. That soon changed.
Over the course of the next several years, I worked hard to implement GMP protocols within my indie beauty brand. That work was a Herculean challenge, since these guidelines were written with huge corporations in mind (though even the tiniest of companies within the U.S. is obligated to comply with them). So I put my nose to the grindstone and crafted distinctive strategies for making these outsized regulations workable for a micro manufacturer like myself.
Teaching GMP to other beauty entrepreneurs has now become a cornerstone of my consulting practice. I often hear from indie beauty brands that they believe they’re compliant, though it’s apparent that they don’t truly understand the GMP mechanisms and how comprehensive they ultimately are. Here’s an analogy I often use to explain the actual scope and power of GMP…
IMAGINE THIS NIGHTMARE-INDUCING SCENARIO…
Imagine that you receive a call from a panicked gentleman who explains that his wife has been using your makeup remover. It was purchased at a local shop, and she’s having a bad reaction when it was applied as directed. He’s driven her to the ER and she’s being examined at the moment. Her eyes are red, swollen, and painful and she’s having visual disturbances. He needs you to send him all the information you can round up about that product ASAP.
That frightening scenario makes my blood run cold. If you own an apothecary company, I imagine that it makes your heart beat faster, too. I’m confident that you could send him all of your company’s contact information. You could probably send him an invoice showing when the product was sold to the shop, provided that John could tell you where his wife made the purchase. You really should be able to send him a complete listing of every ingredient in the product (I’m assuming your ingredient label is complete + accurate, yes?)
But could you send him…
- The date on which that particular bottle of makeup remover was made by your company?
- The origin of every single ingredient that was used in the formula (which supplier the ingredient came from, when the ingredient was received by your company, and the related documentation that shows it met your quality standards)?
- The physical record which displays the exact proportions of ingredients that were used and the conditions under which the eye makeup remover was manufactured?
- The results of any microbial testing that demonstrates that the product was free of bacteria and mold when you originally shipped it to the store?
I imagine that better than 90% of the artisan beauty brands in our sphere couldn’t provide that information. And that’s a HUGE problem. GMP applies to brands big and small. Brands that are created in your kitchen, in your home workshop, and in commercial space. In fact, there’s no brand that’s too big nor too small for GMP, according to the FDA.
GMP IS DESIGNED TO PREVENT ADULTERATION + MISBRANDING
If you thought that being GMP-compliant simply meant adding a batch number to your products, then you should know that’s just the tip of the iceberg. At it’s core, GMP is a series of manufacturing protocols designed to ensure three things:
The United States Code of Federal Regulations (CFR) outlines very specific GMP principals for both food and drug manufacturers, though it’s mum on good manufacturing practices for cosmetic products. However, personal care products within the U.S. are governed by the Food, Drug and Cosmetic Act. That law specifically prohibits the sale of any cosmetic product which is adulterated or misbranded.
Adulterated: Section 601 of the FD&C Act [21 U.S.C. 362] describes what causes a cosmetic to be considered adulterated. A product may be deemed adulterated if:
1. It may be injurious to users under conditions of customary use because it contains, or its container is composed of, a potentially harmful substance.
2. It contains filth.
3. It contains a non-permitted, or in some instances non-certified, color additive.
4. It’s manufactured or held under insanitary conditions whereby it may have become injurious to users or contaminated with filth.
Misbranded: Section 602 of the Food, Drug and Cosmetic Act says that a cosmetic product may be deemed misbranded if:
1. It displays false or misleading labeling.
2. It fails to state prominently and conspicuously any information required by or under authority of the FD&C Act.
3. It has a misleading container presentation or fill.
GMP is a system of ensuring that you could answer all of those questions about the makeup remover, limiting your company’s liability and ensuring that your insurance coverage will pay any necessary damages. But being GMP-compliant delivers a host of other “unseen” benefits that will make your company more efficient, more competitive, and easier to scale.
THE BENEFITS OF GOOD MANUFACTURING PRACTICES
Once you bring GMP into your business, you’ll sleep more soundly at night with more certainty about how you’d stack up if an FDA inspector suddenly showed up on your doorstep. And yes, FDA inspectors can and do show up on doorsteps.
Your personal care brand will get a boost in several areas by being GMP compliant…
1. Products are produced more consistently, reducing waste and increasing profits.
2. Quickly and seamlessly add new production team members as your company grows. Build your empire faster and with fewer headaches.
3. GMP compliance increases confidence.
4. You reduce your vulnerability and minimizes corporate risk when you’re GMP compliant, so your company is poised for long term viability.
5. GMP compliance (when promoted to the public) increases consumer confidence in your brand, which can lead to dramatically increased sales.
6. GMP compliance provides access to huge international markets that your competitors aren’t able to legally access.
7. New federal legislation (which has been teased for years) doesn’t have you trembling in your boots because you’re one step ahead of the game.
GRAB YOUR SEAT IN MY GMP LIVE CLASS
I’ve taught my popular GMP Made Simple(r) class to hundreds of soapmakers and beauty entrepreneurs since 2013. For the last two years, the detailed curriculum has been available “on demand,” but I’m pleased to bring it back in 2019 for the one and only live run of the year. Enjoy the same rich curriculum, plus two group Q+A calls to help clarify concepts, answer your questions, and make recommendations. Grab your seat in my GMP class, as space is limited to ensure that I can give ample time to each participant.
Tomorrow I’ll introduce you to several graduates who are eager to shed some light on how GMP has transformed their businesses. Have a question about GMP? Drop it below… I’d love to hear from you!