f1jim wrote:Maybe Jeff Novick can clear up much of this with a visit. His input is always valuable.
f1jim
f1jim wrote:I am told by our illustrious staff nutritionist that the only nut study getting a B rating is one on walnuts. All the others are C
f1jim
Thanks Jim, and correct.
To help set the record straight, and because of the intensity of this discussion, I also spoke with the FDA yesterday afternoon about the issue and their current position. After all, might as well go directly to the horse's mouth.
As many of you know, in my lectures, From Oil to Nuts, and, Nuts and Health, I cover all of this information in detail including how and why the rating system got started, how it has changed over time and what level is assigned to different foods.
The links being used above to document the claims for nuts are not links to the official FDA website or to their documents related to health claims or to any quotes of theirs, but are links to other various health websites and articles. As we all know, many well-meaning and good-intentioned enthusiastic writers, even those from health websites, often get their information wrong. And, in this case, it appears to be what has happened.
From the FDA
Ranking the Strength of the Evidence for a Health Claim
The first level, or highest rank of scientific evidence to support the substance/disease relationship meets the "Significant Scientific Agreement among qualified experts" standard. (For the purpose of this guidance, the first level rank is only used as a reference point. In all other respects it is outside the scope of this guidance.)
This level reflects a high level of comfort(10) among qualified scientists that the claimed substance/disease relationship is scientifically valid. In general, the first level ranked relationship would be considered to have a very low probability of significant new data overturning the conclusion that the relationship is valid or significantly changing the nature of the relationship. It would have high consistency with conclusions of authoritative bodies. The relationship would be based on relevant, high quality studies of mostly study design types one and two, and sufficient numbers of individuals would be tested to result in a high degree of confidence that results are relevant to the target population. Studies of different design would almost always result in similar findings, and the benefit would be physiologically meaningful and achievable under intake and use conditions that are appropriate for such conventional human food and human dietary supplements that would be the subject of the claim.
The second level rank of scientific evidence to support the substance/disease relationship is the highest level for a qualified health claim, and represents a moderate/good level of comfort among qualified scientists that the claimed relationship is scientifically valid. Qualified experts would rank the relationship as "promising," but not definitive. The claim would be based on relevant, high to moderate quality studies of study design type three and higher (i.e., design types one and two) and sufficient numbers of individuals would be tested to result in a moderate degree of confidence that results could be extrapolated to the target population. Studies of similar or different design would generally result in similar findings and the benefit would reasonably be considered to be physiologically meaningful and achievable under intake and use conditions that are appropriate for such conventional human food and dietary supplements that would be the subject of the claim. (Note: The term "moderate/good" for the second level rank may seem ungenerous. This terminology derives from historical data evaluated by the National Academy of Sciences(11) that indicated that over time many diet/disease relationships that met this level of evidence were not necessarily sustained.) (NOTE: This is the level walnuts received)
The third level rank of scientific evidence to support the substance/disease relationship is the middle level for a qualified health claim and represents a low level of comfort among qualified scientists that the claimed relationship is scientifically valid. It would have low consistency with statements from authoritative bodies or be ranked as "low" in terms of scientific support by qualified scientists. The relationship would be based mostly on moderate to low quality studies of study design type three, and insufficient numbers of individuals would be tested, resulting in a low degree of confidence that results could be extrapolated to the target population. Studies of different design would generally result in similar findings but uncertainties would exist. Uncertainties would also exist as to whether the benefit would be considered physiologically meaningful and achievable under intake and use conditions that are appropriate for such conventional human food and human dietary supplements that would be the subject of the claim. (NOTE: This is the level nuts received)
The fourth level, or the lowest rank of scientific evidence to support the claimed substance/disease relationship, is the lowest level for a qualified health claim and represents an extremely low level of comfort among qualified scientists that the claimed relationship is scientifically valid. It would have very low consistency with conclusions of authoritative bodies or be ranked very low by qualified scientists. The relationship would be based mostly on moderate to low quality studies of study design type three and insufficient numbers of individuals would be tested, resulting in a very low degree of confidence that results could be extrapolated to the target population. Studies of different design would generally result in similar findings but uncertainties would exist. There could be considerable uncertainty as to whether or not the benefit would be considered physiologically meaningful or achievable under intake and use conditions that are appropriate for such conventional human food and human dietary supplements that would be the subject of the claim. This level requires at least some credible evidence to support the relationship. There cannot be a strong body of evidence against the claim (e.g., a study or studies of high persuasiveness, quality and relevance that do not detect an effect). If that is the case, such evidence provides a sound basis for concluding that the claim is not valid.
If the scientific evidence to support the substance/disease relationship is below that described as the fourth level (see above) no claim will be appropriate.
As we can see, the FDA has determined there are four levels of health claims, the top one being an unqualified health claim where there is "Significant Scientific Agreement among qualified experts." Then, there are three lower levels of health claims were the health claim must have a qualifying statement with it to explain why it has not meant the level of "Significant Scientific Agreement among qualified experts."
The FDA has created a tiered chart based on the above, and assigned grade levels of B, C, and D to these qualified health claims rankings and established "Standardized Qualifying Language for Qualified Health Claims," which you can see here...
Scientific Ranking & Standardized Qualifying Language for Qualified Health Claims
Now, lets look at the official health claims for nuts in general and for walnuts specifically
On Nuts in general.
Qualified Claims About Cardiovascular Disease Risk
Nuts & Heart Disease
Docket No. 02P-0505
Claim Statement
Scientific evidence suggests but does not prove that eating 1.5 ounces per day of most nuts [such as name of specific nut] as part of a diet low in saturated fat and cholesterol may reduce the risk of heart disease. [See nutrition information for fat content.}
Types of nuts eligible for this claim are restricted to almonds, hazelnuts, peanuts, pecans, some pine nuts, pistachio nuts, and walnuts.
On walnuts specifically.
Walnuts & Heart Disease
Docket No. 02P-0292
Claim Statement
Supportive but not conclusive research shows that eating 1.5 ounces per day of walnuts, as part of a low saturated fat and low cholesterol diet and not resulting in increased caloric intake, may reduce the risk of coronary heart disease. See nutrition information for fat [and calorie] content.
To make this easier for everyone, I have highlighted the key language in the claims that can be seen in the ranking system. And, as we can see, walnuts specifically, and nuts in general get completely different claims with differing wording, so we know they are not the same. And, the FDA allows a little lee-way in the language as long as certain key words are in there.
As we can see by the wording, nuts (as a general group of the named nuts) get a "C" level claim and walnuts specifically do get a "B" level claim with the key words for each being "suggests" (nuts) and "supporting" (walnuts).
So, as we can see, Laurie Budgar, who writes for the Natural Foods Merchandiser, got the variety of nuts eligible for the claim right, and she and Lauren Neergaard of the Associated Press are both correct about the FDA adding in the new levels for qualified health claims but Laurens comments that "nuts" got a b, is inaccurate.
The confusion by the above linked writers is most likely due to the fact that walnuts were originally part of the generic nut group that got a C rating but 8 months later the grade level for walnuts only was raised to a B. At the time, which is when the above linked articles were written, many people thought that the rankings for all nuts was raised to a B. An understandable error.
Now, IMH(P&P)O, anything less than an A is basically marketing and advertising as the secondary qualified levels did not even exist for many years till the FDA added them due to industry pressure. The only level that existed for many years and the only level that should be accepted is a A level claim and when you read the descriptions above about the four levels, you will see why.
Also, to help put the health claims for nuts in perspective, as a general group (except for walnuts) they have been awarded the same level claim as olive oil, canola oil, calcium supplements for hypertension and calcium supplements for colon cancer which, as most of us know, are fairly weak claims, at best.
In Health
Jeff