“The FDA approved soy protein isolate at a daily intake of 25g despite its own safety committee recommending a maximum of 150mg per day.”

The agency found consistent, clinically significant reductions of total and LDL-cholesterol levels in controlled trials that used at least 25 grams (g) of soy protein per day. Thus, the agency proposed to base the qualifying level of soy protein on a total daily intake of 25 g, as suggested by the petitioner. FDA concluded that the petitioner provided evidence that satisfied the requirement that use of soy protein at the levels necessary to justify a claim is safe and lawful under the applicable food safety provisions of the act.

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.

Therefore, in § 101.82(c)(2)(iii)(A), we proposed the qualifying criterion for a food to bear the claim as 6.25 g of soy protein per reference amount customarily consumed.

Soy protein isolate is listed as a food substance with no specific intake limits mentioned beyond general GRAS determinations; FDA has not challenged its use in foods.

In 1999, we authorized a health claim about the relationship between soy protein and a reduced risk of CHD (§ 101.82). In our 1998 evaluation of the scientific evidence for a relationship between consumption of soy protein and blood total and LDL-cholesterol levels (two validated surrogate endpoints for risk of CHD), we found the data suggestive, but not sufficient, to establish a dose-response for this relationship. However, we found consistent, clinically significant reductions of total- and LDL-cholesterol levels in controlled trials that used at least 25 grams (g) of soy protein per day. Thus, we proposed to base the qualifying level of soy protein on a total daily intake of 25 g, as suggested by the petitioner.

In 1999, the FDA authorized a health claim for soy protein and risk of coronary heart disease (CHD)... Products that contain at least 6.25 g of soy protein per reference amount... The FDA stated that published studies evaluating the effect of soy protein on CHD... were inconsistent and inconclusive. The FDA only examined the studies for consistency... 19 studies showed that soy protein reduced CHD risk and the remaining 27 studies did not.

There are no formal recommendations for soy intake beyond the 25 g/day soy protein established by the US FDA as the threshold intake for cholesterol reduction. Twenty-five g is certainly more soy protein than is consumed by most Asians but through a combination of soyfoods this threshold can be relatively easily met. Since the FDA claim was approved, more than 10 countries have approved similar claims.

The purpose of this review is to provide concise literature summaries along with a short perspective on the current state of knowledge. This article reviews evidence on soy isoflavones and health effects, but does not mention any FDA safety committee recommending 150mg limits or overruling for soy protein isolate approval at 25g daily.

Overall, soy decreased LDL cholesterol by ∼3.2% and TC by 2.8% as a result of consuming ∼25 g soy protein on a daily basis. The lipid reduction was modest but highly significant even if heterogeneous. The FDA is currently considering revoking the heart health claim for soy protein due to a perceived lack of consistent LDL cholesterol reduction in randomized controlled trials.

In 1999, the U.S. Food and Drug Administration (FDA) approved the health claim that a diet low in saturated fat and cholesterol that includes 25 g of soy protein per day may reduce the risk of heart disease. The FDA reached this conclusion after evaluating research from 27 studies. The recommended intake of dietary whole soy protein is 25 g per day, and 40 to 80 mg per day for soy isoflavones.

The FDA leaves it up to manufacturers to evaluate the safety and labeling of protein powders, including soy-based ones. No specific mention of soy protein isolate approval at 25g despite a 150mg safety committee recommendation.

FDA warning letter on RTE Soy Protein Isolate manufacturing under insanitary conditions and failure to identify pathogen hazards. No discussion of safety committee recommendations for 150mg/day or approval at 25g daily intake.

In the original 1998 evaluation, FDA suggested there is a dose effect, observing clinical trials testing dose of 25g of soy protein per day led to clinically significant reductions of total- and LDL-cholesterol levels. The FDA proposed to revoke a health claim on the relationship between soy protein and reduced risk of heart disease, citing 'inconsistent findings' from research published since the claim was authorized in 1999. Dr. Susan Mayne, director of the FDA's Center for Food Safety and Applied Nutrition, stated the move followed an extensive scientific review.

In 1999, FDA authorized the soy protein health claim for CHD risk reduction at 25g/day. In 2017, FDA proposed revoking it due to inconsistent data, but no mention of safety committee recommending 150mg maximum or any overruling related to isoflavones or daily intake limits.

FDA published its final rule today that soy protein included in a diet low in saturated fat and cholesterol may reduce the risk of coronary heart disease by lowering blood cholesterol levels. As a result, food labels may now contain messages, such as '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.'

WASHINGTON--Though two Food and Drug Administration (FDA) scientists made statements that questioned the safety of soy products, the FDA itself issued a comment on Aug. 14 that reiterated its original position. In late May, Drs. Daniel Doerge and Daniel Sheehan wrote a letter to the FDA saying that the soy health claim was issued without enough research into soy's adverse effects on health. However, according to the FDA, soy's benefits outweigh any potential health problems it may cause. After reviewing considerable scientific research, the FDA noted that those who consumed 25 g of soy protein per day would see significantly lowered cholesterol levels and could lower their risk of heart disease. The FDA set its standard [for the health claim] at 25 g of soy protein per day.

They claim that safety issues concerning soy protein products are still unanswered. The two FDA scientists, Dr. Daniel Doerge and Dr. Daniel. Sheehan, have pointed to research that links soy with animal fertility problems. The animal data eludes to possible adverse human health effects. In the doctors' opinion, it is the chemical in soy mimicking estrogen that leads to the potential alteration of an animal's sexual development. [Ross, 2003]”

No FDA safety committee recommended a 150 mg/day maximum for soy protein isolate; the 1999 health claim approval was for 25 g/day based on cholesterol-lowering evidence, with safety confirmed at those levels. Isoflavone discussions sometimes mention mg levels (e.g., 25-100 mg), but not as a safety maximum for protein itself.

In 1999... FDA... authorized the health claim... 'Diets low in saturated fat and cholesterol that contain 25 grams of soy protein per day may reduce the risk of heart disease.'... This health claim was authorized... in 1999... since then... studies published after... show inconsistent results.