As I stated in DD's thread I would post some of the info from the FDA for anyone else who is seriuos about getting their homemade sauces on the market....This is gonna be kind of a long post but there is a lot of info.....
Thank you for your inquiry. Here is some information to get you started.
If you intend to manufacture food products you should first check with your local health department (city and/or county) to determine what types of permits you need to satisfy their requirements. You should also check with your State health department. I believe that you said you have already contacted the state of Ohio. Make sure there are not any more local rules in your area. Some areas do not allow people to make "home made" products and sell them. They require that you manufacture food in a commercial kitchen environment.
With respect to the requirements of the Food and Drug Administration, our primary concerns would be with the 1. food defense 2. manufacturing process and 3. product labeling
1. FOOD DEFENSE/REGISTRATION AND PRIOR NOTICE
Registration
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA by December 12, 2003.
Who must register?
Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register the facility with the FDA. Foreign facilities that manufacture/process, pack, or hold food also are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register. Here is the link to registration under the Bioterrorism Act: http://www.cfsan.fda.gov/~furls/ovffreg.html
You would be required to register under this provision.
Prior Notice
The Act requires that FDA receive prior notice before food is imported or offered for import into the Unites States. Advance notice of import shipments allows FDA, with the support of the Bureau of Customs and Border Protection (CBP), to target import inspections more effectively and help protect the nation's food supply against terrorist acts and other public health emergencies. Here is the link for Prior Notice: http://www.cfsan.fda.gov/~pn/pnoview.html. If any of your ingredients come directly from overseas to you -- you will need to work on this. Otherwise, this would not apply to you.
2. MANUFACTURING PROCESS
When a company manufactures a food product it should take steps to assure that the food products are handled and manufactured in a way that will keep the products free from filth, pesticides, chemicals and other contaminants. This is commonly referred to as Good Manufacturing Practices (GMPs). The GMPs for foods are found in the Code of Federal Regulations 21CFR, Part 110. The following link will take you a site where you can download the regulations http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1 You will need to make sure that your facility conforms with these regulations.
The barbeque sauce product that you are described over the telephone sounds like it is an Acidified Food. There are additional requirements for Acidified and Low-Acid foods. You should determine the pH of your product.
Acid Foods - are foods that have a natural pH of
4.6 or below.
"Natural pH" means the pH prior to processing. However, if a processor receives an acid food (including fermented foods with a pH of 4.6 or below) and during processing allows the pH to rise above 4.6 (through washing, lye peeling, etc.) and then adds an acid or acid food to reduce the pH to 4.6 or below, that product would be considered an acidified food.
Acidified foods - are low-acid foods to which acids or acid food(s) are added and which have a water activity (aw) greater than 0.85 and a finished equilibrium pH of 4.6 or below.
These foods may be called, or may purport to be, pickles or pickled . Carbonated beverages, jams, jellies, preserves, acid foods (including such foods as standardized and non-standardized food dressings and condiment sauces -- like barbeque sauce) that contain small amounts of low-acid food(s) and have a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food, and foods that are stored, distributed, and retailed under refrigeration are excluded from the coverage of this regulation.
Low-acid foods - means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (aw) greater than 0.85.
Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not classed as low-acid foods
Although tomatoes are naturally acid foods, products like salsa have other ingredients such as onions, garlic, cilantro pepper and other ingredients that are low acid. When you add them together those other ingredients are "acidified" by the acid in the tomatoes.
There are additional registration requirements and additional GMP requirements (21 CFR 108 and 113 or 114). This is because these products pose additional health risks -- primarily from botulism. You can obtain more information at: http://www.cfsan.fda.gov/~comm/lacf-toc.html You should read this information very carefully.
It is possible that you will have to register TWICE. Once for food defense issues and once for canned food issues. Please make sure to read about acidified and low-acid foods at the website above.
3. PRODUCT LABELING:
In brief, food labels need to have enough information so that a person can make an informed decision as to whether or not they want to purchase the product. The label should state the name of the product, list of ingredients, manufacturer or distributor address, net weight and nutritional labeling. The listing of ingredients is critical as many people have allergies to ingredients in foods. These allergies can result in serious medical problems for people who eat foods to which they are allergic.
http://vm.cfsan.fda.gov/~dms/flg-toc.html This link will take you to a Food Labeling Guide. This should help you in designing a label for your product. You may also want to hire a consultant or an attorney knowledgeable in food labeling requirements to help you design the label.
With respect to the nutritional analysis of your products -- you need to have your product tested to determine: carbohydrate, fat, protein, vitamins etc. The FDA does not test products for individual companies. You will need to hire someone to do it for you.
As a small business you may qualify for an exemption from the nutritional labeling requirements. The exemption applies only to nutritional labeling. Other requirements such as net weight and ingredients etc. are mandatory regardless of the size of your business. The following link will take you to a page that explains the exemption in greater detail and contains a link to the form you must fill out to obtain the exemption. http://vm.cfsan.fda.gov/~dms/sbel.html
There is a lot of information on the websites in this message. It may seem overwhelming. I would encourage you to take the time to visit each of the sites and study them. Make a list of questions that you have and then call me back if you want and I will try to assist you further.
Compliance Officer
Thank you for your inquiry. Here is some information to get you started.
If you intend to manufacture food products you should first check with your local health department (city and/or county) to determine what types of permits you need to satisfy their requirements. You should also check with your State health department. I believe that you said you have already contacted the state of Ohio. Make sure there are not any more local rules in your area. Some areas do not allow people to make "home made" products and sell them. They require that you manufacture food in a commercial kitchen environment.
With respect to the requirements of the Food and Drug Administration, our primary concerns would be with the 1. food defense 2. manufacturing process and 3. product labeling
1. FOOD DEFENSE/REGISTRATION AND PRIOR NOTICE
Registration
The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA by December 12, 2003.
Who must register?
Owners, operators, or agents in charge of domestic or foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States are required to register the facility with the FDA. Foreign facilities that manufacture/process, pack, or hold food also are required to register unless food from that facility undergoes further processing (including packaging) by another foreign facility before the food is exported to the United States. However, if the subsequent foreign facility performs only a minimal activity, such as putting on a label, both facilities are required to register. Here is the link to registration under the Bioterrorism Act: http://www.cfsan.fda.gov/~furls/ovffreg.html
You would be required to register under this provision.
Prior Notice
The Act requires that FDA receive prior notice before food is imported or offered for import into the Unites States. Advance notice of import shipments allows FDA, with the support of the Bureau of Customs and Border Protection (CBP), to target import inspections more effectively and help protect the nation's food supply against terrorist acts and other public health emergencies. Here is the link for Prior Notice: http://www.cfsan.fda.gov/~pn/pnoview.html. If any of your ingredients come directly from overseas to you -- you will need to work on this. Otherwise, this would not apply to you.
2. MANUFACTURING PROCESS
When a company manufactures a food product it should take steps to assure that the food products are handled and manufactured in a way that will keep the products free from filth, pesticides, chemicals and other contaminants. This is commonly referred to as Good Manufacturing Practices (GMPs). The GMPs for foods are found in the Code of Federal Regulations 21CFR, Part 110. The following link will take you a site where you can download the regulations http://www.access.gpo.gov/nara/cfr/cfr-table-search.html#page1 You will need to make sure that your facility conforms with these regulations.
The barbeque sauce product that you are described over the telephone sounds like it is an Acidified Food. There are additional requirements for Acidified and Low-Acid foods. You should determine the pH of your product.
Acid Foods - are foods that have a natural pH of
4.6 or below.
"Natural pH" means the pH prior to processing. However, if a processor receives an acid food (including fermented foods with a pH of 4.6 or below) and during processing allows the pH to rise above 4.6 (through washing, lye peeling, etc.) and then adds an acid or acid food to reduce the pH to 4.6 or below, that product would be considered an acidified food.
Acidified foods - are low-acid foods to which acids or acid food(s) are added and which have a water activity (aw) greater than 0.85 and a finished equilibrium pH of 4.6 or below.
These foods may be called, or may purport to be, pickles or pickled . Carbonated beverages, jams, jellies, preserves, acid foods (including such foods as standardized and non-standardized food dressings and condiment sauces -- like barbeque sauce) that contain small amounts of low-acid food(s) and have a resultant finished equilibrium pH that does not significantly differ from that of the predominant acid or acid food, and foods that are stored, distributed, and retailed under refrigeration are excluded from the coverage of this regulation.
Low-acid foods - means any foods, other than alcoholic beverages, with a finished equilibrium pH greater than 4.6 and a water activity (aw) greater than 0.85.
Tomatoes and tomato products having a finished equilibrium pH less than 4.7 are not classed as low-acid foods
Although tomatoes are naturally acid foods, products like salsa have other ingredients such as onions, garlic, cilantro pepper and other ingredients that are low acid. When you add them together those other ingredients are "acidified" by the acid in the tomatoes.
There are additional registration requirements and additional GMP requirements (21 CFR 108 and 113 or 114). This is because these products pose additional health risks -- primarily from botulism. You can obtain more information at: http://www.cfsan.fda.gov/~comm/lacf-toc.html You should read this information very carefully.
It is possible that you will have to register TWICE. Once for food defense issues and once for canned food issues. Please make sure to read about acidified and low-acid foods at the website above.
3. PRODUCT LABELING:
In brief, food labels need to have enough information so that a person can make an informed decision as to whether or not they want to purchase the product. The label should state the name of the product, list of ingredients, manufacturer or distributor address, net weight and nutritional labeling. The listing of ingredients is critical as many people have allergies to ingredients in foods. These allergies can result in serious medical problems for people who eat foods to which they are allergic.
http://vm.cfsan.fda.gov/~dms/flg-toc.html This link will take you to a Food Labeling Guide. This should help you in designing a label for your product. You may also want to hire a consultant or an attorney knowledgeable in food labeling requirements to help you design the label.
With respect to the nutritional analysis of your products -- you need to have your product tested to determine: carbohydrate, fat, protein, vitamins etc. The FDA does not test products for individual companies. You will need to hire someone to do it for you.
As a small business you may qualify for an exemption from the nutritional labeling requirements. The exemption applies only to nutritional labeling. Other requirements such as net weight and ingredients etc. are mandatory regardless of the size of your business. The following link will take you to a page that explains the exemption in greater detail and contains a link to the form you must fill out to obtain the exemption. http://vm.cfsan.fda.gov/~dms/sbel.html
There is a lot of information on the websites in this message. It may seem overwhelming. I would encourage you to take the time to visit each of the sites and study them. Make a list of questions that you have and then call me back if you want and I will try to assist you further.
Compliance Officer
