A few of weeks ago TTB’s weekly newsletter covered a number of items about the FDA (http://www.ttb.gov/newsletters/archives/2015/ttb-newsletter073115.html). This raises a commonly asked question about the role of the FDA in alcohol regulation, and their relationship with TTB, so let’s take a look at that. In a nutshell, TTB is responsible for enforcing federal alcohol laws: the alcohol portions of the Internal Revenue Code and the Federal Alcohol Administration Act. FDA, on the other hand, is responsible for enforcing the federal food and drug law: the Food, Drug, and Cosmetic Act. But since beverage alcohol is also a food, how is this line drawn?
History
I’m a history buff, so let me share a brief history lesson. The US government first got involved in alcohol regulation in 1791 when our country’s first tax, on distilled spirits, was implemented to help pay for the Revolutionary War. (This resulted in the Whiskey Rebellion, when tax collectors were literally tarred and feathered. I’m very happy that public sentiment changed by the time I started working for TTB.) This tax was eventually rescinded, but a new alcohol tax was put into place to help fund the Civil War. Alcohol has been taxed ever since then, even during Prohibition. After Prohibition new federal laws were written (the aforementioned Federal Alcohol Administration Act) that addressed issues such as permits, labels, advertising and trade practices. So although taxes are no longer the sole concern of federal alcohol laws, taxes are the one overriding constant, and the reason alcohol laws and regulations are enforced by an agency of the Treasury Department.
The FDA has a completely different history. The US government dabbled in food regulations in the 1800’s, but the Pure Food and Drugs Act of 1906 was the real beginning of the FDA. This Act, and its predecessors, were enacted to prevent adulterated food and drugs. This was, not coincidentally, also the year that Upton Sinclair wrote The Jungle which exposed some very disturbing practices in the meatpacking industry. With its focus on safety and consumer protection, rather than taxes, the FDA is part of the Department of Health & Human Services.
Current Relationship
OK, so TTB is about taxes and the FDA is about food safety*, but what about the safety of alcoholic beverages? This is where the two agencies work together, via a Memorandum of Understanding (MOU). (http://www.ttb.gov/main_pages/memo-understanding.shtml) The gist of this MOU is that TTB relies on the FDA for matters related to health and safety. For example, if you submit a formula to TTB for a specialty distilled spirit containing an unusual ingredient that isn’t readily recognized as food, TTB will require that you provide FDA documentation certifying that the ingredient is Generally Regarded as Safe (GRAS) for use in alcoholic beverages.
For those of you that remember the brouhaha over caffeinated malt beverages a few years ago, there is a reason that the FDA was the one to pull the plug on these products. Many people thought that TTB dropped the ball on this one by not acting sooner, but they had no authority to do so because this was a health and safety matter. TTB did work closely with the FDA on this one, behind the scenes.
So what does this mean for alcohol manufacturers? Historically, it meant that the average alcohol manufacturer had little do with the FDA, but this has changed considerably with recent law changes, such as the Bioterrorism Act and the Food Safety Modernization Act. Here are some issues where alcohol manufacturers will have to interact with the FDA:
I hope this helps clear up the relationship between TTB and the FDA. As an alcohol manufacturer you will have to comply with both agencies. Don’t assume that if you are compliant with one agency that you will be compliant with the other. Because they have different missions, and different laws to enforce, compliance will not necessarily overlap.
Please reach out to me if you have any questions about the role of the FDA in your business, or need help with things like the food facility registration or labeling of cider labels. Thank you – Janene.
*This is an oversimplification, these agencies are more complicated than this. It is the government, after all.
History
I’m a history buff, so let me share a brief history lesson. The US government first got involved in alcohol regulation in 1791 when our country’s first tax, on distilled spirits, was implemented to help pay for the Revolutionary War. (This resulted in the Whiskey Rebellion, when tax collectors were literally tarred and feathered. I’m very happy that public sentiment changed by the time I started working for TTB.) This tax was eventually rescinded, but a new alcohol tax was put into place to help fund the Civil War. Alcohol has been taxed ever since then, even during Prohibition. After Prohibition new federal laws were written (the aforementioned Federal Alcohol Administration Act) that addressed issues such as permits, labels, advertising and trade practices. So although taxes are no longer the sole concern of federal alcohol laws, taxes are the one overriding constant, and the reason alcohol laws and regulations are enforced by an agency of the Treasury Department.
The FDA has a completely different history. The US government dabbled in food regulations in the 1800’s, but the Pure Food and Drugs Act of 1906 was the real beginning of the FDA. This Act, and its predecessors, were enacted to prevent adulterated food and drugs. This was, not coincidentally, also the year that Upton Sinclair wrote The Jungle which exposed some very disturbing practices in the meatpacking industry. With its focus on safety and consumer protection, rather than taxes, the FDA is part of the Department of Health & Human Services.
Current Relationship
OK, so TTB is about taxes and the FDA is about food safety*, but what about the safety of alcoholic beverages? This is where the two agencies work together, via a Memorandum of Understanding (MOU). (http://www.ttb.gov/main_pages/memo-understanding.shtml) The gist of this MOU is that TTB relies on the FDA for matters related to health and safety. For example, if you submit a formula to TTB for a specialty distilled spirit containing an unusual ingredient that isn’t readily recognized as food, TTB will require that you provide FDA documentation certifying that the ingredient is Generally Regarded as Safe (GRAS) for use in alcoholic beverages.
For those of you that remember the brouhaha over caffeinated malt beverages a few years ago, there is a reason that the FDA was the one to pull the plug on these products. Many people thought that TTB dropped the ball on this one by not acting sooner, but they had no authority to do so because this was a health and safety matter. TTB did work closely with the FDA on this one, behind the scenes.
So what does this mean for alcohol manufacturers? Historically, it meant that the average alcohol manufacturer had little do with the FDA, but this has changed considerably with recent law changes, such as the Bioterrorism Act and the Food Safety Modernization Act. Here are some issues where alcohol manufacturers will have to interact with the FDA:
- Registration of food facilities.
- Food safety compliance programs, such as recall procedures.
- Formula approvals with unusual ingredients (as mentioned above).
- Menu labeling (still on hold).
- Labeling of wines and ciders containing less than 7% alcohol by volume, and beers that do not contain barley or hops.
- Facility inspections.
I hope this helps clear up the relationship between TTB and the FDA. As an alcohol manufacturer you will have to comply with both agencies. Don’t assume that if you are compliant with one agency that you will be compliant with the other. Because they have different missions, and different laws to enforce, compliance will not necessarily overlap.
Please reach out to me if you have any questions about the role of the FDA in your business, or need help with things like the food facility registration or labeling of cider labels. Thank you – Janene.
*This is an oversimplification, these agencies are more complicated than this. It is the government, after all.
RSS Feed