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From the PBSW Archives: A word on FDA regulations, or Why I Can’t Cure Your Pentapox…

Posted by Hayley on

Originally published June 14, 2012:

Buckle in, kids, this post’s a heavy one…

Some of you may remember my venting a bit on Twitter a few weeks ago about trying to help a fellow seller navigate the waters of FDA regulations. Ultimately, it was wasted effort – the seller in question decided to ignore my advice – but it did get me thinking about how we as sellers & manufacturers are allowed to market our products, & how little the buying public really knows about those regulations. More importantly, it drove home how important it is that products are labeled truthfully & accurately.

I have received some really wonderful feedback from my customers over the years, including much glowing praise about how my scrubs, butters & creams have helped folks with eczema & chronically dry, itchy skin. I love hearing that my products have brought relief where other treatments didn’t. I try to formulate new products that I believe will help heal, soothe & satisfy.

But here’s the thing – I can’t tell you that’s what they do.

According to FDA regulations, I am allowed to say that my soap will get you clean. If I don’t mind a little extra labeling, I can go so far as to say that my soaps, scrubs & creams make you smell good & moisturize your skin. But that’s it. Period. Full stop.

As long as I label my products accordingly, I am allowed to make claims involving cleaning & moisturizing because those qualities are considered cosmetic in nature – they change the appearance, feel and/or smell of your skin.

The minute I stray beyond these qualities, I enter a perilous new realm. Any mention of my products being intended “to cure, treat, or prevent disease, or to affect the structure or any function of the human body” lands them squarely, in the eyes of the FDA, into drugterritory.

To illustrate, here’s a few examples of things that I absolutely cannot say in product descriptions, on labels, or in my advertising:

“Created for those with: Psoriasis, Atopic Eczema, Irritant Contact Dermatitis, Infantile Seborrheic Eczema, Varicose Eczema, Discoid Eczema, Psoriasis, Dermatitis, Hives, Acne, and other severe skin conditions.”

“Contains Plantain leaf – antibacterial and antimicrobial properties help prevent infection, while anti-inflammatory properties reduce pain, burning, and itching.”

“Helps to heal lips with cold sores or fever blisters with the healing anti-viral effects of Organic Lemon Balm & Organic Calendula.”


“Gentle and Effective Treatment of: Blackheads, Bumps, Whiteheads, Cystic Acne, Imbalanced Complexion”

“Protects against UVA and UVB rays”

…and so on.

Each of these examples (culled, I regret to say, from fellow Etsy sellers) defines the product in question not as a cosmetic, but as a drug. Regulations for cosmetics are reasonably simple & largely self-governing; drug regulations, on the other hand, are understandably much, much more restrictive. In order to legally make the above claims, each of the sellers would have either had to prove to the FDA that their product fit a pre-approved monograph (established requirements for various categories OTC drugs), or submit & pass a New Drug Application with the FDA.

“Yeah, OK, Girl Scout,” someone out there is probably thinking, “But come on, these are little tiny companies. Like the FDA really cares enough to go after them.”

Hey, smart guy. At the end of the day, it’s not about the FDA. It’s about your safety.

Without going through the proper approval processes with the FDA, a seller can, in theory, put any claim they want on any product, whether it works or not. Whether it is safe to use or not. (Want to see what can happen when an indie company ignores FDA regulations? Google Glittersniffer Cosmetics. SPOILER ALERT: a freaking train wreck, is what.)

Buying soap & cosmetics from small, indie businesses requires trust. We make our products with our own hands, as safely as we can, & test them on ourselves, our families, our friends, before offering them for sale to the public. We read up on the rules & regulations & do everything in our power to ensure that we are offering safe, quality products that we can sell with a clear conscience.

But for some, the desire to keep up with the major cosmetics companies overrides common sense, & you end up with sellers like the one I tried to help. They justified ignoring the FDA regulations by saying they had to make medical claims to stay competitive against Big International Skincare Companies. Never mind that what they were offering could have discouraged their customers from seeking proper medical treatment until real damage was done.

So, where does all this leave you? How can you know you’re giving your money to a company who takes your safety seriously? A few words of guidance:

  • Buy from companies that earn your trust. Read feedback, check social media, Google the company & owner’s names. Get to know the people who make the products you’re buying. If something strikes you as odd, dig deeper. When in doubt, trust your gut.
  • Look for safe practices. Tamper-resistant packaging, full ingredient lists, use-by dates & preservative-based formulas all speak to a company’s commitment to good manufacturing processes.
  • Buy from artisans, not self-proclaimed doctors. If you want to treat a medical condition, start with your GP, not a CAPSLOCK junkie.
  • Expect great products & stellar service; leave the miracles to your deity of choice. It’s soap. There’s really only so much it can be expected to do, don’t you think?

(Pentapox? That’s one for the Avatar fans…)