What is Considered Food and Drink Requiring a US FDA Prior Notice?
For international food and beverage producers and vendors, expanding your business into the United States is an incredible opportunity.
But to get your products past the border and into the United States, you must clear the critical regulatory hurdle of the FDA prior notice requirement.
Under the Bioterrorism Act of 2002, the US government requires advanced electronic notice for all commercially imported food items.
This advanced electronic notice requirement is called the FDA “Prior Notice”.
Because the US Food and Drug Administration (FDA) defines “food and drink” broadly, many overseas sellers inadvertently trigger compliance violations without realizing it until it is too late.
Failing to submit proper notice can result in huge problems, including customs delays, seizures, penalties, or property destruction at the port of entry.
To avoid these nightmares, it is important to know what requires a US FDA prior notice and how to submit one.
The Legal Definition: What is Food and Drink?
Exporters of food and beverages must follow the statutory rules established by the US government.
Under US law, Section 201(f) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), “food” includes:
- Articles used for food or drink for man or other animals.
- Chewing gum.
- Any component or ingredient used in these articles.
If your product is intended to be swallowed, chewed, or mixed into a consumable product, it legally requires the submission of a prior notice before it arrives at the US border.
For the complete legal document, refer to US Code Title 21 – Food and Drugs.
Products for Human and Animal Consumption
If your business exports items in any of the following categories, an electronic FDA prior notice is mandatory:
Human Foods and Finished Beverages
- Beverages: Wine, beer, spirits, juices, bottled water, carbonated drinks, coffee beans, and teas.
- Bakery and Confectionery: Pastries, biscuits, chocolates, candies, and chewing gum.
- Snacks and Pantry Staples: Pastas, grains, nuts, dried fruits, spices, sauces, and cooking oils.
- Dairy Products: Cheeses, yogurts, powdered milk, and plant-based alternatives.
Food Ingredients and Processing Aids
Bulk raw materials and chemical food additives are considered to be food components under US law, and require FDA Prior Notices.
These food ingredients and processing aids include:
- Additives: Food colors, texturizers, preservatives, and artificial sweeteners.
- Industrial Ingredients: Bulk flour, starches, raw sugar, and syrups.
- Cultures: Active yeast or bacterial starters used for brewing and dairy processing.
Animal Feed and Pet Food
Because the US law covers food for “man or other animals,” pet care and agricultural sectors must complete exactly the same FDA Prior Notice filings
Animal feed and pet foods include:
- Commercial pet food (kibble, canned food, specialty animal treats).
- Raw agricultural components destined for livestock feed.
Dietary Supplements and Infant Formula
Under US law, vitamins, minerals, and herbal supplements are regulated as a subset of “food”, and not drugs or pharmaceuticals.
Therefore, botanical extracts, protein powders, and dietary tablets require strict prior notice filings. Infant formula is also highly scrutinized.
Ensuring flawless compliance is critical in order to avoid immediate customs holds or rejections.
What is Exempt?
The US government provides very narrow exceptions to the Prior Notice rules. The following types of products and shipments are generally exempt from needing a US FDA Prior Notice:| Category | Details | Regulation | ||
| Personal Gifts | Food sent by a non-commercial individual to another individual in the US for personal use. | US FDA | ||
| Homemade Food | Food made in a personal residence and sent strictly as a personal gift. | US FDA | ||
| Traveler Baggage | Food brought into the country by international travelers for immediate personal consumption. | US CBP |
How to Eliminate Delivery Rejections
Filing prior notices manually requires juggling complex information, including FDA Product Codes, facility registration numbers, manufacturer profiles, and specific batch codes.
A single typo or other small error can lead to an expensive delays and rejections, in addition to the time it takes to submit just one prior notice.
For food distributors, e-commerce stores, and international fulfillment companies, manual data entry is risky and incredibly time consuming.
Using automation software like PriorNotify removes the risks, costs, and hassles of manual data entry, and ensures shipments stay on schedule.
Don’t let international border regulations stall your business. PriorNotify automates FDA Prior Notice filings and submissions, syncing with your e-commerce systems to make everything fast and easy.
PriorNotify automates FDA prior notices, submits instantly, avoids manual data entry errors, and keeps your shipments moving.
Don’t risk supply chain disruptions. Sign up today at PriorNotify.com.
