Which rulebook your drink falls under
| Your drink | Extra federal rules | Panel |
|---|---|---|
| Contains fruit or vegetable juice | Juice HACCP plan, 21 CFR 120 | Nutrition Facts |
| Low-acid (pH above 4.6), heat-treated and sealed to be shelf-stable | Canning registration and process filing, 21 CFR 108.35 and 113 | Nutrition Facts |
| Low-acid ingredients brought to pH 4.6 or below with acid, not carbonated and not kept cold | Acidified food rules, 21 CFR 108.25 and 114 | Nutrition Facts |
| Sold in measured doses to supplement the diet | Dietary supplement rules, 21 CFR 111 | Supplement Facts |
| Kombucha that hits 0.5% alcohol by volume at any stage | TTB rules | TTB labeling and the alcohol health warning |
| Every drink sold as a food, including the juice, low-acid and acidified ones above | Food cGMP, 21 CFR 117, and FDA facility registration | Nutrition Facts |
Drinks with juice: the HACCP rule
The juice rule is wider than most founders expect. It covers juice used as an ingredient in a beverage, not only bottles of straight juice. So pressing your own lemons for a bottled lemonade or tea brings part 120 with it.
- A written hazard analysis, and a HACCP plan for each location and each type of juice when a hazard is reasonably likely
- A process that cuts the most resistant harmful microorganism by at least 5 log (100,000-fold), for the whole shelf life
- Treatment applied to the juice itself; only citrus processors may treat the fruit surface instead
- Treatment and final packaging in one facility operating under cGMP
- Sanitation procedures, records, and a trained person to write and review the plan; that person does not have to be your employee
A juice bar that only sells to its own customers is a retail establishment and sits outside part 120. The moment you also sell bottles to cafes or stores, you are a processor.
Shelf-stable cans and bottles
Want your drink on an unrefrigerated shelf? Then the pH decides the paperwork. A low-acid drink that is heat-treated in a hermetically sealed container is a low-acid canned food in FDA terms. Its processor has 10 days from the first production run to register on Form FDA 2541. A scheduled process for every product and container size follows, no later than 60 days after registration and always before a new product is packed.
Juice processors already under part 113 or part 114, or that use one thermal step that makes the juice shelf-stable, are exempt from the separate 5-log rule, as long as the thermal process is in their hazard analysis. The scheduled process must be set by qualified people with expert knowledge of thermal processing, usually called a process authority.
Beverage or liquid supplement: decide before you design
Wellness shots, vitamin waters and powdered drink mixes can be either a food or a dietary supplement. The choice changes your panel, your allowed ingredients and your claims, so make it before the label artwork. FDA's guidance on liquid supplements adds some points that catch founders out:
- Powders and liquid concentrates you stir into water can be dietary supplements, as long as they are not presented as a beverage or an alternative to one
- A powdered lemonade mix stays a food, because lemonade is a beverage
- Adding a botanical to a familiar drink does not turn it into a supplement: FDA's examples are ginkgo in a powdered drink mix or in non-alcoholic eggnog
- Lawful in a capsule does not mean lawful in a soda: every substance added to a beverage needs GRAS status for that use, an additive approval or another exception
- The supplement disclaimer does not belong on a beverage label
When alcohol enters the picture
Fermented drinks need a close eye. TTB treats kombucha as an alcohol beverage once it hits 0.5% alcohol by volume, whether that happens in the tank, at bottling or later in the bottle. That means production on TTB-qualified premises, TTB labeling, tax rules and the alcohol health warning. Below that line at every stage, FDA rules apply.
Your facility, registration and state licenses
- Register the bottling facility with FDA before production starts, and renew every other year. Get a DUNS number first
- Make every batch under food cGMP, 21 CFR 117
- Keep records of where each ingredient came from and where each case went
- Ask your state health or agriculture department about a food processor license, and your city about a business license
Starting from home? Cottage food laws differ a lot on drinks. New York, Connecticut and Mississippi list beverages among the foods you cannot sell from a home kitchen. Idaho's law goes the other way and includes drinks like coffee, lemonade, tea and soda. Georgia's definition of a cottage food item names nonalcoholic beverages. Check your state before you bottle anything:
- Alabama
- Alaska
- Arizona
- Arkansas
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Idaho
- Illinois
- Indiana
- Iowa
- Kentucky
- Louisiana
- Maine
- Maryland
- Massachusetts
- Michigan
- Minnesota
- Mississippi
- Missouri
- Nebraska
- Nevada
- New Jersey
- New Mexico
- New York
- North Carolina
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Washington
- West Virginia
- Wisconsin
Example: honey lemon iced tea, 16 fl oz bottle
Ingredients: Brewed tea (water, tea), honey, lemon juice.
- Sweetened tea has a reference amount of 12 fl oz (360 mL). A 16 fl oz bottle holds less than twice that, so the whole bottle is one serving: "1 bottle (473mL)"
- Honey counts as added sugar here: 24 g, which is 48% of the Daily Value
- The ingredient list names lemon juice, so the label needs a percent juice statement. Percent juice is counted against the whole drink: 1/2 cup (about 120 mL) of lemon juice in a finished batch of about 4,200 mL (tea plus honey plus juice) is 2.8%, declared as "Contains 2% lemon juice", a whole number not above the real figure
- If you squeeze those lemons yourself, the juice falls under the juice HACCP rule
- "16 FL OZ (473 mL)" as the net contents, placed in the lower 30% of the front panel
- Tea, honey and lemon juice contain none of the 9 major allergens, so there is no Contains line
Make the label for your first run
Enter your batch in our label maker, tick Liquid, and set the serving as a volume or as one bottle with its mL. You get Nutrition Facts with FDA rounding, the serving in mL, the ingredient list in order by weight and the allergen statement. Need Supplement Facts for a shot instead? That mode is built in.
- Juice, tea, coffee, milk, plant milks, coconut water and sweeteners are in our USDA-matched library
- Using a flavor, an extract or a bought-in syrup? Copy the values off the supplier's panel by hand, or upload a photo and check what we read
- PDF at actual size and print sheets for Avery labels, for a test run before you order printed rolls
- A calculation report that shows the co-packer or store buyer where each number came from