Enjoy Your Life! Build Your Business! Have Your Way!
I contacted the EPA last week, inquiring about whether I could legally make and sell a natural mosquito repellant lotion bar (that uses essential oils to repel). I received an email back, letting me know that they are looking into it for me, but haven't received the answer to my question yet. We are currently having labels designed and I'd love to know one way or another ASAP, so that our graphics guy can know whether to move forward with his part on that one or not, and also so that I will have a clear idea of which products we can launch with.
I've seen many natural mosquito repellants, some handcrafted and others very commercial, but after learning recently about the difficulties of legally making/selling SPF lip balms (or anything with SPF), I am afraid to get my hopes up on this one. I have heard that the EPA is even more complicated than the FDA when it comes to regs--I hope that's not true! Thanks ahead of time for any insight!
Insect repellents are regulated by the Environmental Protection Agency pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). They are also regulated differently in some states. When researching this issue, it's important to check FIFRA and any laws that exist in your own state.
Regarding FIFRA, generally, pesticides must be registered unless they are exempt.
They are exempt if they are deemed "minimum-risk pesticides" by EPA. The fact that a product is exempt from federal EPA registration as "minimum-risk pesticide" does not necessarily mean it's exempt under state law. Again, it's important to check.
EPA defines a "minimum-risk pesticide" very specifically. You can see the list of requirements here.
I don't want to discourage you, but considering your other question about SPF and your response to that above, here's some encouraging news -- you can make and sell thousands of products without SPF, and that are not drugs and not pesticides, and you can make a healthy profit doing so.
My suggestion is to focus on products you can make easily and safely with minimal regulatory concerns and build a solid brand and business platform that generates a steady stream of income. Once you've done that, you'll have the resources (both time and money) to get into products that are a bit more heavily regulated.
You can see FIFRA in all its glory here.
EPA also has state and regional offices you can contact to ask more specific questions about laws in your state.
Hope this helps.
Thanks for your response! 2 of the 10 original items I had originally planned to launch with are "outdoor" items--partly because of our own lifestyle (we naturally thought of them when brainstorming ideas), and partly because of the type of stores locally that were good prospects for selling for us (family owned outdoor sports stores). Fortunately, there are other prospects as well--those 2 products just represented a different category. Thanks for the encouragement regarding the less regulated stuff! I will be glad when this stage is over and we can start selling! Blessings!
For anyone coming across this thread also seeking information on EPA regs on mosquito repellent, here is the response I got from the EPA (as you will see, it looks like quite a process to get the product approved!):
Thank you again being in touch with the U.S. Environmental Protection Agency's Office of Pesticide Programs - Biopesticides and Pollution Prevention Division (BPPD).
Many of the questions you have will be covered in the 'pre-submission meeting', which is scheduled after a product has been given a biochemical classification. The next best steps for your product are for you to separate the ingredients into a list of active and inert ingredients, and for you to email them to my colleague Russell Jones (cc'd) for biochemical classification. When emailing Russell, please provide the following information (please note that if you consider this Confidential Business Information (CBI), please do not send the information via email):
1) If it is a naturally occurring compound
2) What is the mode of action (the purpose and formulation of each active ingredient, and how it works against the target pest)
3) The history of exposure (have humans been exposed to these active ingredients?)
Russell can be reached at email@example.com
Once Russell has made a biochemical classification for your product, I will be in touch with pre-submission meeting information.
Additionally, the web links provided below offer helpful information from the EPA on regulating biopesticides, as well as "tools" for biopesticide regulation:
The web links provided below offer helpful information from the EPA on regulating biopesticides, as well as "tools" for biopesticide regulation:
I also wanted to relay that since the registration process is so complex, the U.S. EPA recommends - but does not require - that registrants consider working with a biopesticide regulatory consultant. A partial list of consultants is maintained at this website:
Thank you for your post, it's kind of disheartening learning about the SPF & Bug Repellant because customers have asked for those from us as well, but I also agree with DM regarding waiting until our businesses are more profitable and work on the items with a little less regulation for now.