Our Verdict: SAFE

Vitamin A

CAS68-26-8FDA GRAS

This additive is considered safe

Based on current FDA and EFSA assessments. Approved in both the United States and the European Union.

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

United States

Approved

FDA

European Union

Not_evaluated

EFSA

Vitamin A โ€” food additive

Vitamin A is an essential fat-soluble nutrient added to foods to prevent deficiency and support human health. It is widely used in fortification programs for dairy products, cereals, and supplements, with no reported adverse events or recalls in FDA databases.

US Status

Approved

FDA

EU Status

Not_evaluated

EFSA

Adverse Events

0

FDA CFSAN

FDA Recalls

0

OpenFDA

Global Regulatory Status

United States
ApprovedFDA
European Union
Not EvaluatedEFSA
United Kingdom
UnknownUK FSA
Canada
UnknownHealth Canada
Australia
UnknownFSANZ
Japan
UnknownMHLW
South Korea
UnknownMFDS
Brazil
UnknownANVISA
China
UnknownNHC / GB 2760
India
UnknownFSSAI
Country data is sourced from official regulatory databases and enriched via AI analysis. Always verify with the relevant national authority before making dietary decisions.

What is Vitamin A?

Vitamin A is a fat-soluble organic compound essential for human nutrition and physiological function. The term "Vitamin A" typically refers to retinol and its naturally occurring and synthetic derivatives, including retinyl acetate and retinyl palmitateโ€”the forms most commonly added to food products. Vitamin A is designated by CAS Number 68-26-8 and functions as a nutrient supplement in food applications.

Common Uses

Vitamin A is added to a wide range of food products as a fortification ingredient. The most common applications include:

- Dairy products (milk, cheese, butter, yogurt)

- Breakfast cereals and grain-based foods

- Margarines and spreads

- Nutritional supplements and fortified beverages

- Plant-based milk alternatives

Fortification programs using Vitamin A are particularly important in developing countries where deficiency-related diseases remain a public health concern. In developed nations, fortification helps maintain adequate population-level intake and addresses dietary gaps among specific populations.

Safety Assessment

Vitamin A holds Generally Recognized as Safe (GRAS) status with the FDA, indicating it meets safety standards for use in food. The FDA's adverse event database contains zero reported incidents associated with Vitamin A food additives, and there have been zero recalls linked to this ingredient. This track record reflects decades of safe use in food fortification globally.

Importantly, toxicity risk from food-fortified Vitamin A is considered negligible for the general population when consumed through normal dietary means. The bioavailability and dosage of Vitamin A in fortified foods are carefully controlled. Hypervitaminosis A (toxicity from excessive intake) is primarily associated with high-dose supplementation rather than food fortification, and requires sustained intake far exceeding normal dietary levels.

The European Food Safety Authority (EFSA) has established tolerable upper intake levels for Vitamin A based on comprehensive toxicology reviews. These established safety margins account for individual variation in sensitivity and ensure protective guidelines for vulnerable populations including pregnant women and children.

Regulatory Status

Vitamin A is approved for use as a nutrient supplement in food in numerous regulatory jurisdictions worldwide, including the FDA, EFSA, and food safety authorities in Canada, Australia, and Japan. It appears on the FDA's GRAS list and is permissible under specific conditions regarding concentration limits and labeling requirements.

Regulatory frameworks specify maximum permissible levels in various food categories to prevent excessive intake while ensuring nutritional benefit. These limits vary by product type and intended consumer demographics. The FDA and EFSA regularly review emerging science to ensure established safety margins remain appropriate.

Key Studies

Decades of epidemiological research demonstrates that Vitamin A fortification programs effectively reduce deficiency-related diseases, particularly in vulnerable populations. Clinical studies have established recommended dietary allowances and upper intake levels based on metabolic requirements and safety data.

Large-scale prospective cohort studies and randomized controlled trials have characterized Vitamin A's physiological roles in vision, immune function, and cellular differentiation. Research on fortification efficacy shows consistent bioavailability of retinyl acetate and retinyl palmitate in food matrices.

Safety reviews by expert panels, including those conducted by the Institute of Medicine and international food safety bodies, have consistently concluded that Vitamin A fortification at permitted levels presents no safety concerns for the general population when used as intended.

Frequently Asked Questions

What is Vitamin A?

Vitamin A is an essential fat-soluble nutrient added to foods to prevent deficiency and support human health. It is widely used in fortification programs for dairy products, cereals, and supplements, with no reported adverse events or recalls in FDA databases.

Is Vitamin A safe?

Vitamin A is currently rated "safe" based on FDA and EFSA data. It is approved in the US and not_evaluated in the EU. There are 0 FDA adverse event reports associated with this additive.

Is Vitamin A banned in any country?

Vitamin A is approved in the United States and not_evaluated in the European Union. Review the regulatory status cards above for the most current information.

Data Sources

Data is sourced exclusively from official government databases and updated periodically. This page does not constitute medical advice. Consult a healthcare professional for dietary guidance.