Do you need FDA approval to sell water?

Author: Shawn McClure  |  Last update: Saturday, October 4, 2025

The Food and Drug Administration (FDA) regulates bottled water. FDA regulations for bottling water include Good Manufacturing Practices (GMPs), standards of identity and labeling requirements. These regulations are posted in the Code of Federal Register and are enforced at the state level.

What can you sell without FDA approval?

The ingredients (except certain colors) and labeling of cosmetics, such as many perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations do not require FDA approval.

Do beverages need FDA approval?

The Food and Drug Administration (FDA) regulates all foods and beverages distributed in the United States except products that are regulated exclusively by the US Department of Agriculture (USDA).

What water is not regulated by the FDA?

Sterilized water is free from all microbes. Note: Carbonated water, soda water, seltzer water, sparkling water, and tonic water are considered soft drinks and are not regulated as bottled water.

Is water considered food by the FDA?

Water is a food as defined in section 20l(f) of the Federal Food, Drug, and Cosmetic Act (2l USC 32l(f)). It is a normal constituent of many foods and is essential in the preparation and processing of most commercially prepared foods.

Do You Need FDA Approval To Sell Food? - CountyOffice.org

Do I need FDA approval to sell water?

However, some states may require approval of bottled water products sold within their states. It is the responsibility of the bottled water manufacturers to ensure that their prod- ucts in interstate commerce comply with all applicable provisions of the FFDCA and FDA's regulations for bottled water.

Does FDA approve water?

The Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) are both responsible for the safety of drinking water. EPA regulates public drinking water (tap water), while FDA regulates bottled drinking water.

Is Dasani water FDA approved?

DASANI meets all FDA Bottled Water Regulations Standards of Quality. View the water quality report here.

Is water federally regulated?

The U.S. Environmental Protection Agency (EPA) is responsible for making sure that public water supplies in the United States are safe. To protect people's health, EPA sets and enforces standards and regulations to limit harmful germs and chemicals in tap water.

Is distilled water FDA approved?

FDA has issued comprehensive bottled water Standards of Identity, which provide uniform requirements and definitions for the following bottled water classifications: drinking, artesian, groundwater, distilled, deionized, reverse osmosis, mineral, purified, sparkling, spring, and well water (21 C.F.R.

Is it illegal if not FDA approved?

FDA Approval is Required by Law

Federal law requires all new drugs in the U.S. be shown to be safe and effective for their intended use prior to marketing.

Does my product need to be FDA approved?

While not all products require pre-approval by the FDA, the FDA still has regulatory authority in the event of public safety concerns. The FDA has regulatory authority in the event of a public safety issue related to your product.

How long does FDA approval take?

Once the application is submitted, the FDA has 6 to 10 months to review the information and decide whether to approve the drug or not.

Can you sell products without listing ingredients?

If an ingredient used in the product conforms to a standard of identity or is a multi-ingredient product, its ingredients are required to be listed on the label.

Is bottled water FDA regulated?

The U.S. Food and Drug Administration regulates bottled water products, working to ensure that they're safe to drink.

What is the water law in the US?

The Safe Drinking Water Act (SDWA) is the main federal law that ensures the quality of Americans' drinking water. Under SDWA, EPA sets standards for drinking water quality and oversees the states, localities, and water suppliers who implement those standards.

What waters are federally controlled?

These waters include: Coastal waters (Coastal waters are the Atlantic Ocean; the Gulf of Mexico; and all bays, sounds, harbors, rivers, inlets, etc., where any entrance is over two miles wide to the first point where the distance between shorelines narrows to two miles.)

Is Aquafina tap water?

Aquafina originates from public water sources and is then purified through a rigorous purification process. This purification process includes reverse osmosis and other filtering and purification methods. It removes things like chlorides, salts and other substances that can affect a water's taste.

Is distilled water sterile?

In summary, distilled water is sterile, but sterile water isn't always distilled. Distillation takes it another step toward perfection. Distilled water is still your best choice.

What are the requirements for water labeling?

FDA requires all food product labels, including bottled water labels, to conspicuously specify the name and place of business of the manufacturer, distributor, or packer, which provides consumers with the necessary information to contact the firm to obtain information about a specific brand of bottled water.

Does the USDA regulate water?

The U.S. Department of Agriculture (USDA) works with agricultural producers to implement best management practices that minimize water quality and water quantity — the availability or use of water — issues.

What does the FDA code require of a water system?

Final answer: The FDA Food Code requires a hot water system in a food establishment to be maintained at 100°F (38°C) and meet the peak hot water demand. These requirements ensure food safety and prevent contamination.

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