This article was written by Kelly Bloom of Southern Soapers. It has been reprinted here in its entirety with express permission. You can read the original on Kelly's blog.
Are you a Drug Dealer? Are you a small micro bath & body business? Do you sell lotions to prevent sunburn, or made to block the damage of the sun on skin? Do you sell products for diaper rash, acne blemished skin, eczema or psoriasis, hot flash sprays, anti bacterial products? All these items, and many more examples, are considered by the FDA as Over The Counter Drugs. Manufacturing and selling these products requires following many federal guidelines that far exceed what is required to manufacture soap or cosmetics.
The most common response is for the formulator to simply change the name of their product to try and obfuscate what it really is. I hate to be the bearer of bad news, but just changing the name of a product does not make it legal to sell.
Over the last few years we have become very complacent thinking that since we can make almost any product the larger manufacturers make, that we can sell them too. We started off making just soap, and then expanded to emulsions, balms, and gels as we learned formulating skills, learned more about cosmetic science, and ingredients became more readily available. Gradually, we have added an entire pharmacy of treatments to our product lines though… MSM for pain relief, Essential Oil blends for insect repellent, herbal infused balms to make bruising fade, ointments to make healing go faster, balms for treating diaper rash, products for eczema and psoriasis, SPF or Sunscreen/Sunblock lotions, anti-fungal products for toe nail infections, blemish sticks for acne complexions.. the list goes on and on and on.
None of these products should be sold to customers or distributed to treat or prevent conditions by homebased or indie beauty cosmetic or soap companies. You can make these products for yourself, but it violates FDA regulations to sell these untested, unregistered products to others. No matter what you call these products, if customers buy these products for the intended use to treat themselves with them, than they are OVER THE COUNTER DRUGS. This makes the seller technically a drug dealer, drug manufacturer, or distributor of drugs. So … JUST SAY NO TO DRUGS. We tell our kids to say no to drugs, now it is time for us to lead by example.
You may not feel the FDA & EPA regulations are fair, or that you should have to abide by them. If we all do what we think or feel we are entitled to though, we have anarchy. The regulations on OTC drugs are there for your safety as a consumer. The regulations are there to ensure your trust and confidence when you purchase an over the counter treatment for your sick child. The FDA is there to ensure that Over the Counter Drugs have been:
1. Manufactured in properly registered facilities
2. That the manufacturers have used cGMP (current Good Manufacturing Procedures) to manufacture these over the counter drugs
3. That OTC products are properly labeled with the ‘Active’ ingredient listed separately from the rest of the product formulation, and conforms to drug product ingredient listing format, which differs from cosmetic labeling.
4. that the manufacturer has done safety testing, to include studies to determine dosage, frequency of usage and any possible side effects. These studies often require several years to conduct so that the products are properly evaluated on scientific data, not just someone’s personal testimony.
While it may seem unfair that we can not sell these types of products, it is also important to remember that the very fact that these products are effective is all the proof the FDA needs to prove that your product is actually a drug and not a cosmetic. A catch 22. By proving your lavender Essential Oil blend for postmenopausal facial spray really does make anxiety and hot flashes go away, you also prove the product is a drug. Additionally, many are not aware that while your HSMG or IBN Business Liability Insurance is valid for soap, cosmetics, and candles, it does NOT provide coverage for manufacturing OTC or new drug products.
The FDA is here to protect the consumer being sold untested and possibly dangerous concoctions by snake oil salesmen. We only need search Google to see fine examples of entities hawking miracle cures for everything to increasing bust size (and other appendages) to diet success, to hair regrowth, or rolling back the years of time. Some might even work.. I don’t know about you though .. but I do not want to be lumped into that category of snake oil salesmanship.
Best advice for new and old soapmakers and formulators alike… if a customer asks what you have for insect repellent, pain relief, sun screen, diaper rash, insomnia, nerves, antibacterial products, ointments for broken skin or bruises, etc.. Tell them that YOU ARE NOT a DOCTOR, can not diagnose, can not prescribe, and sell only soap and cosmetics. If your goal with your business is to treat peoples problems, than you need to revisit your business plan and possibly enroll in a program that will allow you to legally diagnose and prescribe treatments. If your goal is to have a successful bath & body business than you would want to focus on that - bath and body products. It will not only serve your business better, but you will be legally compliant.
Be sure to see the FDA Links in our blog roll. Here is the most relevant one: FDA: Drug, Cosmetic, or Soap?
Get familiar with the FDA website where you can validate what you can and can not manufacture for resale. Don’t simply rely on what you see others getting away with, or seeking someone that will tell you what you really want to hear. Only you will bear responsibility if you are not following the FDA regulations. It will not matter if someone outside the FDA gave you erroneous advice.
This is an important topic and I thank Kelly for bringing it up and putting it out there for everyone to see, learn and research so we can all stay safe.
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