FDA Supports Cocoa Flavanols

FDA Supports Cocoa Flavanols

In a letter of enforcement discretion, the FDA announced it has no intention of challenging the use of certain properties of cocoa flavanols, which the FDA considers to be beneficial for health. The letter additionally states that consumption of flavanols reduces the risk of cardiovascular disease.

For conventional foods, as long as the qualified claim is worded appropriately to avoid misleading consumers and other factors for use of the claim are met, there is no problem. This is similar to what is expected in this case.

The request made by Barry Callebaut AG Switzerland

Barry Callebaut AG Switzerland submitted a health claim petition to the FDA. The company requested a review of the qualified health claim related to the consumption of flavanols from cocoa powder and the reduced risk of cardiovascular disease.

A health claim characterizes the relationship between a substance and a disease or health-related condition.

What are cocoa flavanols?

This is a specific class of compounds within a much broader family of polyphenolic compounds, which are known as flavonoids. You can find them in various foods and drinks of plant origin. Some of them are cocoas, chocolates, teas, red wines, fruits, cereals, beans, spices and nuts.

The US Department of Agriculture (USDA) has developed a database, which contains information related to the flavanol content in many foods. The best thing about this is that the information is available on their website, which makes it accessible to the public.

Cocoa flavanols are present in cocoa and chocolate to a greater or lesser extent. Its amount will depend on the type of cocoa and the processing used to achieve a finished product.

High Flavanol Cocoa Powder: What Does the FDA Say?

It is still intended to exercise discretion for compliance with the qualified health claims that will be described below. But to do so, the labeling of flavanol in cocoa powder needs to be improved. Remember that labeling is essential for compliance with the law:

  1. Cocoa flavanols in high-flavonoid cocoa powder may reduce the risk of cardiovascular disease. While this is a claim it accepts, the FDA concludes that the scientific evidence is very limited for such a claim.
  1. Consumption of high-flavonoid cocoa powder, which contains at least 4% naturally preserved cocoa flavanols, may reduce the risk of cardiovascular disease. However, as mentioned in the previous point, the scientific evidence is very limited.

Remember, accurate labeling is crucial for compliance. The label should state that the cocoa powder contains at least 4% naturally preserved flavanols and reference the FDA's qualified health claim.

What is the US Food and Drug Administration

FDA stands for Food and Drug Administration. This is a federal agency within the Department of Health and Human Services. Its main function is to protect public health, guaranteeing the safety, effectiveness and protection of various products.

Some of the products regulated by the FDA are:

  • Food: To ensure the safety of our food supply, from farm to table, including items such as dietary supplements, bottled water, and food additives.
  • Medications: Regulates both human and veterinary medications, ensuring they are safe and effective for their intended use.
  • Biological Products: This includes vaccines, blood and blood products, and gene therapy products.

  • Medical Devices: Ensures the safety and effectiveness of medical equipment, from simple bandages to complex medical equipment.
  • Cosmetics: Ensures cosmetics are safe to use and properly labeled.
  • Products that emit radiation: This includes electronic products that emit radiation, such as X-Ray machines and cell phones.

In addition to regulating, this organization provides information to the public, related to the products consumed or about which people express doubts. With this data, people can make an informed decision, always for the benefit of their health.

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