Regulations for producing consumables in a home-based business

[Nuday]

I am currently formulating an herbal remedy that will be deliverable via a spray bottle to the mouth. What sort of regulations do I need to look out for in terms of producing a consumable product out of my home? I assume there are both federal and local regulations. I'm in Massachusetts if anyone has experience doing anything similar here.

I know I will be exempt from a nutrition label, and I plan on printing ingredients on the bottle. Given that I am marketing it as an herbal or natural remedy, I assume I wil need to put the typical "these claims not endorsed by the FDA" label on there as well. Will I need to establish a dedicated area of preparation, or simply be able to show I bring my work area up to a certain standard of cleanliness when I produce and package my product?

If anyone has been in a similar boat and has any links to specific regulation, I would greatly appreciate them. I've been trying to search through the FDA website, but I've found it hard to discern what is and is not applicable to me. Thanks!

[vangogh]

Welcome to the forum Nuday. First let me say I have absolutely no idea what the answers are to your questions. This is far from my area of expertise. However, I want to help keep your thread active so I did a little bit of research.

On a site discussing regulations in Canada I found this about the U.S.


In the United States, many natural health products are regulated as "dietary supplements," which means they do not require pre-market review or proof of safety by the manufacturer before marketing, and they cannot make treatment/cure claims.

I'm not sure how you determine if that applies to what you're producing, since you're calling it a remedy. It sounds like you might not be able to use the word remedy given the above. I then found this page on FDA site about dietary supplements (http://www.fda.gov/food/dietarysupplements/)

Here's a PDF I found. It's a small business guide to the FDA (http://www.fda.gov/downloads/ForIndustry/SmallBusinessAssistance/SmallBusinessGuidetoFDA/UCM081030.pdf). I don't know if it'll have the information you need, but it does list some regional offices. There's one in Stoneham, which looks like it's the closest one to you. I might start by giving the regional office a call. I'm thinking the regulations you need to meet are going to be from the FDA. If not I would think they could point you in the right direction.

[Nuday]

Wow, thanks a lot! I didn't come across that small business FDA guide before, I'll give it a close read. I'd prefer not to, but paying for at least an hour sit down with a lawyer may be in my future just to make sure by butt is covered.

[vangogh]

In the end talking to an attorney is probably the best thing to do. Most of us here can share what we know or in my case search for something I hope is helpful, but an attorney will have much better advice. Nothing wrong with learning what you can first though. It'll help you choose an appropriate attorney and also help you know what questions to ask.