This was already posted in a link above:

http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=563f0b6235da3f4c7912a64cbceec305&rgn=div8&view=text&node=21:2.0.1.1.2.1.1.6&idno=21

(j) The following foods are exempt from this section or are subject to special labeling requirements:

(1)(i) Food offered for sale by a person who makes direct sales to consumers (e.g., a retailer) who has annual gross sales made or business done in sales to consumers that is not more than $500,000 or has annual gross sales made or business done in sales of food to consumers of not more than $50,000, Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. Claims or other nutrition information subject the food to the provisions of this section.

(ii) For purposes of this paragraph, calculation of the amount of sales shall be based on the most recent 2-year average of business activity. Where firms have been in business less than 2 years, reasonable estimates must indicate that annual sales will not exceed the amounts specified. For foreign firms that ship foods into the United States, the business activities to be included shall be the total amount of food sales, as well as other sales to consumers, by the firm in the United States.

(2) Food products which are:

(i) Served in restaurants, Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. Claims or other nutrition information subject the food to the provisions of this section;

(ii) Served in other establishments in which food is served for immediate human consumption (e.g., institutional food service establishments, such as schools, hospitals, and cafeterias; transportation carriers, such as trains and airplanes; bakeries, delicatessens, and retail confectionery stores where there are facilities for immediate consumption on the premises; food service vendors, such as lunch wagons, ice cream shops, mall cookie counters, vending machines, and sidewalk carts where foods are generally consumed immediately where purchased or while the consumer is walking away, including similar foods sold from convenience stores; and food delivery systems or establishments where ready-to-eat foods are delivered to homes or offices), Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. Claims or other nutrition information subject the food to the provisions of this section;

(iii) Sold only in such facilities, Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. Claims or other nutrition information subject the food to the provisions of this section;

(iv) Used only in such facilities and not served to the consumer in the package in which they are received (e.g., foods that are not packaged in individual serving containers); or

(v) Sold by a distributor who principally sells food to such facilities: Provided, That:

(A) This exemption shall not be available for those foods that are manufactured, processed, or repackaged by that distributor for sale to any persons other than restaurants or other establishments that serve food for immediate human consumption, and

(B) The manufacturer of such products is responsible for providing the nutrition information on the products if there is a reasonable possibility that the product will be purchased directly by consumers.

(3) Food products that are:

(i) Of the type of food described in paragraphs (j)(2)(i) and (j)(2)(ii) of this section,

(ii) Ready for human consumption,

(iii) Offered for sale to consumers but not for immediate human consumption,

(iv) Processed and prepared primarily in a retail establishment, and

(v) Not offered for sale outside of that establishment (e.g., ready-to-eat foods that are processed and prepared on-site and sold by independent delicatessens, bakeries, or retail confectionery stores where there are no facilities for immediate human consumption; by in-store delicatessen, bakery, or candy departments; or at self-service food bars such as salad bars), Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. Claims or other nutrition information subject the food to the provisions of this section.

There is NO labeling requirement for bakeries regardless of sales amounts unless I am reading this wrong. But I'm not. Nobody in my kitchen labels exc ept the few that sell to Whole Foods.

Thanks, Jason!

FromScratch, what confused me (besides the lengthy FDA explanations) was the statement that bakeries are restaurants. In the link I provided, a bakery is considered a restaurant only if food is consumed on premise. Many bakeries today do have onsite seating. But there are bakeries that have no seating; and home bakeries would also not qualify.

But apparently it doesn't matter all that much since the agency responsible for enforcement doesn't explain the rules to its employees.

The only part that seems to apply to shipping is the exemption for "food delivery systems or establishments where ready-to-eat foods are delivered to homes or offices", but I'm pretty sure that refers to meal delivery services and catering as opposed to shipping baked goods through the mail.

Of course I could be wrong, it seems like the FDA itself doesn't know how it wants to regulate this type of transaction and their regulations have not caught up to the current technology infrastructure that allows for easy interstate order fulfillment.

My takeaway from all this is that if you have under $50K in annual revenue you definitely don't need to worry about labeling from the FDA's perspective. If you make more than that and aren't clear on the FDA regs you'll want to get something in writing from your local FDA rep.

I had a long conversation about the labelling issue with the health department here the last time I did my inspection. What it boiled down to was that IN VIRGINIA (I can't say how other states do it), if you sell directly to the person who will be eating the product at the time of delivery (i.e.wedding cakes etc) you don't need to have a label on the product. That exemption comes in as long as the consumer has a chance to ask you about any ingredients that may be in the product. So if I have a tasting appointment with a client and they have an opportunity to ask me about what goes into the cake, I don't need to label it. Farmer's markets do require labels here, though, as far as I know. I don't sell at farmer's markets though, so I suppose you could get away with not labelling if you did talk to the clients about ingredients at the time of purchase.

The inspector did say that the main reason to label was for allergies, not for the nutritional values. So he suggested that even if I don't put a label on my cakes, I supply a list of the things that are considered common allergens that would go along with the cake at the time of delivery. I added a line at the bottom of the information sheet I take with the cake that says "the cake was produced in a kitchen that also processes wheat, nuts, dairy and eggs." Then if it's a vegan cake I'll add that it has soy in it, or whatever I think people might want to know. That way the venue has the information if someone asks them about it.

I'd think that the allergen issue would be the reason to label what's in the product if you were shipping it. It sounds like there are enough exemptions that you don't need to do a full-blown nutritional value label for a bag of cookies that you sell on Etsy, but I'd still do the ingredient label in case someone has food allergies.

Are we missing something here? I think this conversation about shipping may have to do with the OP who posted another thread about business being slow. http://cakecentral.com/modules.php?name=Forums&file=viewtopic&p=7242959&highlight=#7242959

So why do businesses ship products that are available to customers in the customers' own locality? Especially with the BUY LOCAL trend. I certainly understand if a specialty business has a unique product, something they do very well that no other bakery makes. Or businesses that have been doing this for many years and have a loyal following. But with new businesses starting out, add in the shipping cost for customers, and I wonder if it's a viable alternative to supplementing income because local customers are not supporting the business.

Is shipping product a good alternative if ones local business is slow?

I think it's simply because everyone is getting so used to ordering online - - it doesn't matter much where the seller is located. If they happen to spot something they like, they'll order it, no matter where it's coming from and most people aren't going to spend the time or energy to see if they can get it locally.

Businesses ship for different reasons. It offers their customers convenience, it can help keep in touch with those customers that move away from the area and reach those customers that aren't always able to get to the retail location of the business.

Just because a business ships doesn't take away the local aspect from it.

I can only speak for myself, I live in a high tourist area and a large part of my sales are cakes and cupcakes that people order because they are visiting San Francisco for an event of some sort (I deliver a LOT of birthday cakes and cupcakes to hotels and restaurants). Those people find me online and just order based on my reviews. I hear from a lot of them after the fact begging me to ship to them because I offer cake unlike any in their area. That's why I started researching and asking around about the legalities and what I needed to do several months ago. I was also curious because November and December was crazy busy at my kitchen with all kinds of new people booking time to make confections that they ship just for the holidays. They make it look and sound so easy it got me thinking that it's something I'll be able to offer in the near future.

I don't think I would be interested in shipping if I didn't already have default interest from tourists coming here.

To clear up the interest of why we would be interested in shipping if local sales are slow??

We bake inside of a chocolate shoppe who does 98% of their profit fom Internet sales and shipping. This December they did over $50,00 in shipping sales. The owner has asked several times if we would be interested in listing our cake pops on their online service.

I was just trying to see if we need labels, to do this because it's a no cost possible way to increase our sales.

The owner has no answer for shipping regulations. His philosophy: it's better to ask forgiveness than to ask permission.

On another note.... We had an amazing last two weeks of sales. Orders came in like crazy, and we sold out of product each day. We did ok for our first holiday, and second month in business.

Good to hear you are doing well, recent post you were closing business? Sounds like you should try the mail order business. Good luck.

Thank you very much for all those that did an amazing amount of legwork in getting answers.

I'm new to this and I just want to clarify that my understanding is correct. I was getting a little confused about all of the explanations so thought I would run it back by everyone to double check.

I'm want to get everything together to register and get my residential kitchen inspected locally in MA, so I can start advertising my cake and cake pops and know I'm doing it all above board. I have seen people selling cake pops on ETSY and as a stay home mom, I thought it would be a good way to start being able to sell some from home and generate a little income (I know it wouldn't be much). After reading about shipping I was worried that I might be breaking some laws and couldn't afford to be hit with a large fine if I unknowingly did the wrong thing.

Do I have this correct ------- If I register my home business and get a license to prepare food made in a residential kitchen (which I know I need for my local area), then complete the FDA registration link that was posted (short form) am I right to start selling and shipping around America?

I really appreciate everyone's help in advising me.

In many states with cottage food laws, interstate and mail order are not allowed. That's the case in NY where I live and unfortunately, that's true for MA also. http://www.mass.gov/agr/markets/specfood/food_processor_resource_manual.htm

CHAPTER FOUR: Residential Kitchens: Questions and Answers

What marketing and volume restrictions are there on residential kitchens?

Residential kitchens are allowed to sell directly to consumers or directly to retail food stores and food service establishments within the Commonwealth of Massachusetts. The U.S. Food and Drug Administration (FDA) does not acknowledge a private kitchen in someone's home as an approved source of foods for interstate commerce. Mail order sales from residential kitchens are also prohibited for this reason. In turn, Massachusetts does not consider foods prepared in outofstate residential kitchens as an approved food source. To limit production of foods to safe and manageable volumes, the regulation prohibits the use of brokers, wholesalers, and warehouses by residential kitchen operators to store, sell, and distribute foods prepared in residential kitchens. Another restriction on production volume is the requirement that only household members may be employed in the operation.

Copies of Massachusetts regulation 105 CMR 590.000 Minimum Sanitation Standard for Food Establishments Article X are available from the State House Bookstore; 617-727-2834. Correspondence should be addressed to: Retail Unit; Food Protection Program; Massachusetts Department of Public Health; 305 South Street; Jamaica Plain, MA 02130; 617-522-983-6712. (End of Reprint)

Sorry... But there are other ways to earn a nice income through home-based food production. Good luck!

I have been gone from CC for almost a month and I cannot believe this thread is still going.

In this time, I have had a tremendous opportunity to sell on a national level. I'm not sharing details at this point, but the contract is finalized as of today and it is a done deal.

The person who contracted me had the same information I had concerning FDA issues. We had never met or discussed this before and our conversation on this subject consisted of a few sentences.

I propose to you all a question:

If your local HD has no jurisdiction on shipping, and as you all propose, the FDA doesn't care, who do you answer to? Is shipping truly a way for every person living in a tent with a grill suddenly in business? This is an exaggerated hypothetical situation, but what are the rules as you all have interpreted?

I am going to give you a recent "for instance" in my family. The government has recently taken over DOT physical exams. My husband has been doing these for years. The problem was that local doctors were passing people with serious medical conditions and they were killing people in auto accidents. The gov stepped in and required a major course to be completed, many plane trips out of town to the courses, and a tough exam to be passed in order to perform these exams. Now there are very few physicians who can examine these drivers and the physician is responsible for negligent findings through audits. But other things changed too. The lab had to be updated to FDA standards and the restroom and plumbing had to be reconfigured to meet the requirements. He is now subject to FDA inspections. When commerce crosses state lines, there has to be a governing entity responsible for the requirements and the inspections. That is where fed takes over from the state.

There are numerous gov sites stating the requirements for federal food safety in shipping, but if what you all are saying is true, nobody is policing this food as no one has legal jurisdiction. How can this be so in the real world?

Maybe you all are right, but it doesn't make sense to me to have a "do whatever floats your boat" law. The parts of the application specifically mention home kitchens not being allowed and specifics on separate kitchens in homes such as floor drains, three basin sinks, and proper surfaces. This is where I got my specs.

My kitchen passes, so I really don't care. I am not the distributor on my new venture, but she did read it the same way I did. She is a former Washington DC business consultant , working for the government mentoring small businesses. The work we are doing involves governments, both local, state, and federal.

Has anyone read the application?

I give up, sorry, the documents are in my desk and I read them a milion times. Money was not really an object for my bakery, so we did what we needed to do. I am a licensed contractor so I could easily follow the code myself for both governing entities. If the labels have limitations, that makes some sense that may need further review, but to have no construction code to follow and no governing body to answer to when food safety is such a huge concern even on a local level, I just don't know.

Why did my local HD, which is one of the most strict in the country, say that when I got FDA approval, they would no longer inspect my bakery? I know the answer is that you don't need it through the exemptions, but again, who do you answer to? And it is certainly not your local HD.

So ship all you want, but the fines are also detailed. They are a per diem fine for the length of the violation. On one document, I think it is six months and the other 90 days. So if I am right, 270 days of fines are the starting point. And since I was a witness for two years in an IRS fraud case, I know for a fact that when you are violated by one dept, they send a nice little note off to the IRS for an audit. Luckily, my books accounted for every penny. It was my accounting that showed the fraudulent books of the.other business. But I sure was glad I was squeaky clean before they came in and got my books. They get your bank statements, tax returns, etc, before they notify you. Other witnesses in that case had some issues pop up.

Good luck, but be careful. I'm sure the documents I have in my possession with the federal seal are the same for everywhere.

And as for the person who stated that maybe the gov doesn't know how to handle this and it's a case of slipping through the cracks, this is not so. The feds didn't care about interstate shipping until 9/11. That day sparked the heavy regulations.

And again, if the FDA's ultimate purpose is to have clear documentation of ingredient to final consumer, how can they do this if the rules don't apply? What is the point of registration? So the can send you a Christmas card? Think of the logics behind the why's, who is responsible for compliance (in this thread scenario, there are no compliance codes, inspectors, etc), look at the application, and then decide.