FDA GRAS Notice 947: What It Is and What It Is Not

What a GRAS notice is

GRAS stands for "generally recognized as safe." A company that concludes a food ingredient is GRAS for its intended uses can send the FDA a notice explaining why. The FDA reads it and replies by letter. The conclusion in the notice belongs to the company, and the FDA's letter is a reply to it.

What GRAS Notice 947 covers

CABOSSE Naturals NV submitted GRAS Notice 947 to the FDA on 1 June 2020, and the notice was prepared by Exponent. It covers cacao pulp, cacao fruit juice and cacao fruit juice concentrate, and runs to 144 pages. The FDA responded with a letter saying it had no questions about the notifier's conclusion that these uses are GRAS. The notice itself does not give the date of that reply, so we do not state one.

The notice lists maximum use levels by weight: pulp or juice concentrate up to 20% in beverages and, in other foods, juice concentrate 10 to 65% and pulp 15 to 50%.

What it measured

For the commercial juice, the notice reports total polyphenols averaging 61.9 mg per 100 g and a pH of 3.0 to 3.3. For pulp and juice it reports a trace of theobromine, 0.55 to 0.65 mg per 100 g, and caffeine below the limit of detection in the juice. See the nutrition facts for the full list.

What it is not

• It is not a sign-off by the FDA on any product, and it is not an endorsement.
• It says nothing about health effects, and it reports no antioxidant activity.
• It covers cacao pulp, juice and juice concentrate for the uses described. A finished product still has to be judged on its own formulation and process.

How to describe it accurately

Accurate: "Cacao pulp, juice and juice concentrate were the subject of GRAS Notice GRN 947, to which the FDA responded with a no-questions letter." Wording to avoid: saying the FDA endorsed or certified a product, or using the notice to support any health claim.

The European Union

A separate decision applies in the EU. Commission Implementing Regulation (EU) 2020/206 of 14 February 2020 authorised cacao fruit pulp, pulp juice and concentrated pulp juice as a traditional food from a third country.

Sources

• CABOSSE Naturals NV (notifier). GRAS Notice GRN 947: Cacao pulp, cacao fruit juice, and cacao fruit juice concentrate (FDA response: no questions). U.S. FDA GRAS Notice Inventory, 2020. Notice (PDF) (opens in a new tab).
• Commission Implementing Regulation (EU) 2020/206 of 14 February 2020 authorising the placing on the market of fruit pulp, pulp juice and concentrated pulp juice from Theobroma cacao L. as a traditional food from a third country. Official Journal of the European Union.

Learn more

• What the studies report - What published studies and GRAS Notice 947 report
• Regulatory status - How cacao pulp and juice are treated in the United States, the European Union and Brazil
• Safety information - Serving suggestions and cautions
• Nutrition facts and sources - The measured values and where each comes from

This content is for educational purposes only and summarizes published sources. It is not medical advice.