Soy protein health claim.

What 21 CFR 101.82 covers

Section 101.82 is the authorized health claim for "soy protein and risk of coronary heart disease (CHD)." As with other health claims it opens with the regulation's findings in (a) and (b), then gives requirements in (c), optional information in (d) and model claims in (e). Its history line is a single entry, 64 FR 57732, October 26, 1999. The eCFR text on this page is current through October 29, 2026. It carries an "Effective Date Note" about paragraph (c)(2)(ii)(B), described below, and this page reports that note as printed.

What the claim says: paragraph (c)(2)(i)

• (A) Diets that are low in saturated fat and cholesterol and that include soy protein "may" or "might" reduce the risk of heart disease.
• (B) The disease is named "heart disease" or "coronary heart disease."
• (C) The substance is named "soy protein."
• (D) The fat component is named with the terms "saturated fat" and "cholesterol."
• (E) No degree of risk reduction is attributed.
• (F) The claim does not imply that such diets are the only recognized means of reducing risk.
• (G) The claim specifies the daily dietary intake of soy protein needed to reduce risk and the contribution one serving makes. The section says the daily level associated with reduced risk is "25 grams (g) or more per day of soy protein."

What counts as soy protein: paragraph (c)(2)(ii)

The substance is soy protein from the legume seed Glycine max. Paragraph (c)(2)(ii)(B) describes how FDA assesses it: total protein is measured by the AOAC method referenced in 101.9(c)(7). For a product whose only protein source is soy, soy protein is treated as equal to total protein. For a product with other protein sources, FDA calculates soy protein "based on the ratio of soy protein ingredients to total protein ingredients in the product," using information the manufacturer supplies such as nutrient databases, recipes or purchase orders. Manufacturers must keep records that substantiate the claim as long as the product is marketed and provide them on written request. The section's Effective Date Note says this paragraph contains information collection and recordkeeping requirements and "will not become effective until approval has been given by the Office of Management and Budget." This page does not assert whether or when that approval was given.

What the food must contain: paragraph (c)(2)(iii)

• (A) At least 6.25 g of soy protein per reference amount customarily consumed.
• (B) The 101.62 requirements for "low saturated fat" and "low cholesterol."
• (C) The 101.62 requirement for "low fat," unless the food consists of or is derived from whole soybeans and contains no fat beyond what is inherent in them.

The 6.25 g figure is a quarter of the 25 g daily level, which is why four servings of a product at the minimum would supply the full 25 g.

Optional information and model claims: paragraphs (d) and (e)

The claim may mention that heart disease depends on many factors and name general risk factors, describe the intermediate link of blood cholesterol, add the summaries from (a) and (b), say it is consistent with the Dietary Guidelines, advise people with elevated cholesterol to consult physicians (mandatory if the claim defines high or normal levels), and cite sourced national counts of people with heart disease. The two model claims read: "25 grams of soy protein a day, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease. A serving of [name of food] supplies ____ grams of soy protein." and "Diets low in saturated fat and cholesterol that include 25 grams of soy protein a day may reduce the risk of heart disease. One serving of [name of food] provides ____ grams of soy protein."

Worked example

A bar has 12 g of total protein per reference amount, and 60 percent of its protein ingredients are soy. Under the ratio method, soy protein is 12 x 0.60 = 7.2 g, which is above the 6.25 g minimum. One serving supplies 7.2 / 25 = 28.8 percent of the 25 g daily level, so the claim's "A serving supplies ____ grams of soy protein" blank would be 7.2 and about 3.5 servings would supply 25 g. If the soy share were 40 percent, soy protein would be 4.8 g, below the minimum. The calculator above does this arithmetic. The low saturated fat, low cholesterol and low fat tests are on the saturated fat claim page and are not repeated here.

Limits of this page

The tool multiplies and compares; it does not substantiate the soy ratio, which needs records the manufacturer must keep. It does not apply 101.14, 101.62 or the general rules for wording and placement, and it is not medical or compliance advice.

Sources

Sources opened and read November 2, 2026.

• eCFR: 21 CFR 101.82, Health claims: Soy protein and risk of coronary heart disease (CHD) (current through October 29, 2026) (read November 2, 2026)
• eCFR: 21 CFR 101.62, Nutrient content claims for fat, fatty acid, and cholesterol content of foods (read November 2, 2026)