Sooo, I stumbled into a little situation today and found out that I have to be registered with the FDA. Talked a nice enough guy named Robert and he confirmed that this needed to be done.

So here's the scoop from what I understand from my chat with him:

If you have a separate kitchen that is used for the purpose of a food business you must register with the FDA. As of 2003 it doesn't matter if you ship goods or not you must register. He told me you are exempt if local regulations allow you to use your home kitchen but if you have a separate kitchen in your home or on your property for food business purposes you must register. Further, if you ship (or have shipped to you) food items from overseas that is a whole nuther kettle of fish so you better call yourself and get the 411.

Just thought some of you may want to do this or at least check into it. I had NO IDEA!!! I've had my biz for 5 years and never got wind of this. I just left a message for my HD inspector to chat with her about it and let her know. I told Robert (Mr.FDA in my house) that I would pass the word on this.

Now, is it likely the Feds are gonna knock on your door? Prolly not but the registration was quick and painless and I ain't gotta sweat it. My HD is pretty strict and I had to go the whole nine yards so I'm pretty confident that I have met all of the requirements. I filled out the information and hope it won't bite me in the butt later.

I just thought I would pass this on... not trying to be the food police or anything

Did he back this up with a reference to the FDA food code on what the FDA's specific requirements are?

I did find this clarifying document, which states that the FDA has jurisdiction over food that is composed of ingredients that were shipped across state lines (which is just about everything).
http://www.fda.gov/ICECI/ComplianceManuals/CompliancePolicyGuidanceManual/ucm073820.htm

Timely post!

We have a post going over in the Cupcake forum about shipping cake pops and someone brought up FDA rules. Do you ship? I am going to call the local FDA office to see what I need to do, but it sounded like what was needed for shipping was way more trouble than it may be worth. What paperwork did he say you had to do and what was the aprox cost?

Could the operational word here be "manufacture"? Not every HD in the country can be wrong. Plus, my information came directly from the FDA. Here is my information from them:

The FDA license must be acquired for interstate commerce except in the condition of the Fair Trade Between States Act. This pertains to people on state lines, such as myself. I had to comply with all Of Washington Co., MD laws, submit to their inspections, have filed with them my WV license and my insurance, and file MD sales tax. I do not have the ability to sell to other parts of the state unless I get the license, which is cheap, but not needed by me. My kitchen must also be in compliance. But this type of state line situation does not fall under FDA jurisdiction.

As for shipping across state lines except on a state line, the FDA has jurisdiction. Also, any worldwide shipping out of the country is FDA jurisdiction. If I choose to get my FDA license, which again, is only the cost of the license without the interstate shipping, I will be exempt from all local inspections and I can sell as far as I want in my area which includes WV, PA, MD, and VA, just not shipping. I still must pay all applicable sales tax to each state.

If anyone chooses to ship across state lines, except for the exemption, One must have an approved kitchen, register with the Bioterrorism Act, have a recall protocol, keep daily logs on their forms for a set amount of time, have all products nutritionally analyzed, and have an approved FDA nutritional label.

Only separate kitchens can be approved. No home kitchens are allowed. Floor drains are a must, which most separate kitchens do not have.

If you read the application and look at the logs for production and have the recall protocol, you will see that it is set up for manufacturing. It is actually difficult to convert a bakery production to the forms.

Since I have met all requirements and worked very closely with the FDA, I would think that this huge issue would not be overlooked. I also do not believe that they don't know their job. It is my belief that in this situation, a bakery is not a manufacturing entity, therefore, not in the jurisdiction of the FDA.

A Pepperide Farm bread plant in the middle of a state with no out of state commerce but with ingredients from another state may be what they are referring to.

Well, I am certainly not going to go around with anyone about this. It was new information to me and I thought I would pass it on for each one to do what they will with it. I was very clear to the person I spoke to that I decorate cakes and cookies from a separate kitchen in my house, don't know how much more plain I can get than that. Again, just trying to help and give the info that was given to me.

Lenette, I'm not trying to go round and round either, but every local HD would have to be wrong across the entire US. I operate in two states with the exact same information from MD State Health Dept (not local) and the Dept of Ag itself.

If you actually read the application, you may find the answer you are looking for. My local HD in WV gave the same information.

Again, there are different forms in the application for processing plants and manufacturing.

I am not claiming that anyone is wrong, I don't profess to know the law, health codes or be an expert on anything. I was just going off what I was told when I called the FDA help line. If I was misinformed then I apologize for posting in the first place.

Lenette, this is a forum. You can post anything you want. I have spent a fortune on an FDA kitchen. I have read every single word on every form and worked for six months with the authorities. My information is not from one phone call, but through the entire six month construction of my commercial kitchen. Not one stone was left unturned because shipping is in my future.

I am also on a state line where I had to comply with the laws of two different state and I not only deal with interstate commerce daily, I am purchasing ingredients interstate also. If I needed to register with the FDA due to this, I would have been informed by one of the three HD's that I am subjuect to, plus the Dept of Ag/FDA.

On another related note: With the deadly recalls we have seen in recent years, anyone in baking would be prudent to have a recall protocol in place. It involves you knowing where your products came from and where they went.

An elementary protocol would consist of always buying your products the same brand and from the same store. For example, I always buy GM AP flour, Land o Lakes butter, eggs (always the same brand) from Walmart. I buy dairy from a local farm. Fresh churned butter from the Pa Dutch Market. You get the idea. Because my protocol is in place, preparing for a much more detailed record in the future, if there is a recall, I don't have to wonder if my eggs, for example, are tainted. I can go to the time I used the tainted product and my orders will show where they went.

If we ever do have a problem, I'm sure the insurance company and the FDA will be happy to see a recall protocol, even a simple plan, in place.