Are You a Drug Dealer?
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.
July 9th, 2009 at 10:15 pm
That was a very interesting article.
July 10th, 2009 at 3:50 am
What a fantastic informational article. The FDA’s article was particularly interesting and explained the whole Is it a cosmetic, a soap or a drug question in layman’s terms, easy to understand what they are aiming at. Thanks for sharing this with us.
July 10th, 2009 at 5:00 am
Excellent article Kelly, and I agree with most everything you say here. I get so put off when I see my colleagues making miraculous drug claims for their products. It damages the industry as a whole and people should “just say no”, as you indicate. I would like to add though that while we must abide by FDA rules, they heavily support the drug manufacturers and big pharma, so I don’t consider them to be the ultimate safety net they would like us to think they are.
July 10th, 2009 at 7:24 am
Maggie, I have to concur that the FDA is certainly not perfect. We hear in the news periodically about drug recalls due to additional, dangerous side effects that slipped past the initial FDA review process. It is this imperfect record that is also driving the FDA Globalization Act of 2009. I am still hopeful that the cosmetics portion will be separated out of that bill by the time is is finally up for vote.
July 10th, 2009 at 7:54 am
One question comes to mind~ with all the Extra Goodies the Gov is putting in our products, preservatives and things that have been TESTED safe for us~(then we find out they are not really as safe as we thought) Wonder what the requirements are for herbal or organic products. I know I’m not stating my position clearly, I’ve been up all night so I’m tired. BUT maybe ya’ll can figure out where I’m going. My son is going to school for Medicine(Botany), but he wants to work in the discovery field, finding new drugs to combat disease. He’s looking into All Natural Remedies, he says most drugs are now synthetic and only but plant based so he’s looking into I guess this Chinese method of herbs and healing? In fact, In addition to his college tuition, he NOW wants to attend an herbalist school (I heard there’s a good one in NY) Where you go and learn about plants, herbs, etc and live in the woods for a couple of weeks.
Any way you look at it, it’s great info~Info SO many people choose to ignore or just don’t know as newbies, so it’s good to keep putting it out there. I just think we all should have the right to eat, drink, and medicate as we choose, not as the Gov dictates. Unfortunately, we have to base our regulations on what is good for the whole, not what is good for a few. But we should have choice. That’s where I get aggravated. I don’t want the Gov to be able dictate WHAT I purchase or WHATS available to purchase. It’s like soap, I CHOOSE to use handmade soap. I know for a fact it’s different than store bought soap I would hate to think the Gov feels it’s no longer safe for folks to make since some people learn to make soap on Monday and sell at market on Friday and usually are selling lye heavy soap. It’s all good now, but what about the future? Which is why it’s so important to keep our voices vocal and in their face~!
Again~ Thanks Kelly
July 10th, 2009 at 8:04 am
I agree with this article 100%. The cottage bath / body industry has no business making medical claims or hints. I really don’t see what the FDA (good or bad) has to do with inexperienced people making medical claims.
And to be honest, do you really think it’s a good idea to allow someone who has just graduated from formulating in a kitchen and moved up to formulating in a backyard shed (from lowe’s) to sell you any type of cure or treatment?
I know that all sounds harsh, but this really is a recipe (formula?) for disaster.
July 10th, 2009 at 8:28 pm
I wasn’t aware that the government was actually putting anything in our products. Can you elaborate on that? Thanks!
The government’s many bad choices/regs/decisions don’t make bad formulation safe. I honestly don’t understand that logic.
Besides, if the big guys have to prove medical claims, why not the little guys?
July 17th, 2009 at 9:26 am
Kelly, you have certainly stimulated alot of discussion on this topic which is a very good thing. Thanks.
August 18th, 2009 at 10:16 pm
Added this page to Digg
September 5th, 2009 at 2:41 am
Over the years, the importance of herbs has increased in the cosmetic industry. The main benefit of using herbs over chemicals in cosmetics is that they are natural and they do not have any side-effects. Also the results are permanent. Most herbs do not cost a lot like chemical cosmetics.
September 6th, 2009 at 12:48 pm
Julie
I would have to absolutely, positively disagree with what you are stating here. First, Herbs are also chemicals. Everything in nature is a chemical. You are a mixture of chemicals. The demonization of ‘chemicals’ in our products is actually quite irresponsible. It is even more irresponsible to claim that herbs do not have any side effects. This is vastly untrue and incredibly false information to pass around. Nor are any results that herbs create any more permanent than any synthetic substance of similar nature. Last, the cost of herbs is not cheaper than chemical cosmetics.
January 24th, 2010 at 10:29 am
Well said, smart lady!
I’d like to reprint this on The Soap Bar for others to see, too. Spreading the word… let me know if this is okay.
-Jo
January 24th, 2010 at 10:32 am
Joanna, absolutely! Please feel free to reprint,