At least 711 of you responded to our
Starting in October 2003, we asked visitors to this website to send comments to the FDA about the following questions.
We believe that the answer to 1 is YES and the answers to 2 and 3 are NO.
Regarding question number 1, in response to pressure from food manufacturers the FDA says the wording may be confusing. We say the wording is perfectly clear and will confuse nobody. That is why the answer to question number 1 must be YES.
Regarding question numbers 2 and 3, if you consume ten servings of different products each with 0.45 grams of trans fat, you have consumed 4.5 grams of trans fat. Yet each serving was "trans fat-free" or contained "zero grams of trans fat"! According to FDA arithmetic, 0 x 10 = 4.5. This is why the answer to question numbers 2 and 3 must be NO.
At least 711 of you emailed your comments to the FDA before the FDA stopped accepting email comments in September 2007. Thank you. You made a difference!
Here are the comments that
October 9, 2003
TO THE U.S. FOOD AND DRUG ADMINISTRATION
DOCKET NO. 03N-0076; RIN 0910-AC50
These comments are made in response to the Advance Notice of Proposed Rulemaking (“ANPR”) published in the Federal Register on July 11, 2003. [Fed. Reg., Vol. 68, No. 133, July 11, 2003 at page 41507.]
ABOUT OUR ORGANIZATION
BanTransFat.com, Inc. is a non-profit corporation organized under the laws of the State of California.
On May 1, 2003, we filed a lawsuit against Kraft Foods North America, Inc. seeking an injunction against the sale and marketing of Oreo cookies containing trans fat to children in California. As a result of the lawsuit, Kraft announced that almost across the board, it would eliminate trans fat, or cut it to about half a gram per serving in cookies and crackers. As we were successful in achieving our goal, we voluntarily dismissed the lawsuit.
There was enormous national publicity during the week of May 12, 2003 regarding the lawsuit. Tens of millions of people who were previously unaware of the presence and danger of trans fats in their food products suddenly became aware, and word is continuing to spread.
On May 14, 2003, a poll was conducted by America Online regarding the lawsuit. 655,296 people voted. 26% responded that “something needs to be done” about the trans fat problem. This is a very substantial percentage – a quarter of the population. We believe that if a poll were taken of women only, the percentage would be much higher judging by the e-mail that we have received. This is important, because women are more likely than men to be the food purchasers for families.
Our website has been visited more than 140,000 times since May 12, 2003. Approximately, 75,000 visits have occurred since we dismissed the lawsuit. Hundreds of people visit the website every day. In fact, it would be fair to say that it is now the leading trans fat website in the world. A Google or Yahoo search for “trans fat” or “trans fats” will bring up our website at the top of the list. This is important because it means that we are almost certainly receiving more e-mail from people interested in the trans fat issue that any other governmental or non-governmental organization. We are able to assess the views of consumers simply by reading the thousands of e-mails that they have sent to us.
The e-mails that we have received show that the American people are deeply concerned and very angry about the presence of trans fat in food and the lack of proper labeling. A selection of the e-mail is posted on our website, which we urge the FDA to review. It is a very valuable source of consumer research.
We have not posted on the website the hundreds of e-mails that we have received from people who are confused by lists of ingredients that indicate the presence of partially hydrogenated oil, but zero grams of trans fat. However, we will be happy to provide such e-mails to the FDA upon request (with names removed).
THE FDA’S MANDATE IS TO PROTECT
Under the Nutrition Labeling and Education Act of 1990, the FDA “shall” require that the declaration of nutrients “be conveyed to the public in a manner which enables the public to readily observe and comprehend such information and to understand its relative significance in the context of a total daily diet.”
There is a timing element implied in the statutory mandate. Unnecessarily deferring mandatory labeling until 2006 violates the mandate. Trans fat labeling was first proposed by the FDA as long ago as November 1999. The FDA has estimated that 2,100 to 5,600 lives each year are being lost as a result of the bureaucratic delay. [Fed. Reg., Vol. 64, No. 221, November 17, 1999 at page 62772.]
Walter Willett, M.D. of the Harvard Medical School, who is widely acknowledged as one of the world’s leading experts on nutrition, estimates that 30,000 or more cases of coronary heart disease are caused each year in this country by trans fats. [Eat, Drink, and Be Healthy: The Harvard Medical School Guide To Healthy Eating by Walter C. Willett, M.D, at p. 73.]
The FDA’s explanation is that the delay is necessary “to minimize the need for multiple labeling changes and to provide additional time for compliance by small businesses to allow them to use current label inventories and phase in label changes.” [Fed. Reg., Vol. 68, No. 133, July 11, 2003 at 41466.] We are completely unimpressed by this explanation, and so too are large numbers of our supporters who have made their views known to us by e-mail. We feel compelled to remind the FDA that the statute requires the FDA to protect “the public,” not the food industry. The FDA has elevated an extremely minor commercial issue - preprinted label inventories - above its statutory responsibility to save lives and prevent disease. The FDA’s state of mind concerns us and our supporters greatly. The FDA needs to work on rebuilding trust with consumers.
While the FDA’s decision on the timing issue is now behind us, the FDA in the ANPR is inviting comments about unresolved trans fat labeling issues. However, the initial signs in the ANPR are worrying. The six footnote options on which the FDA is seeking comments look like they were written by the food industry, or to appease the food industry.
The FDA should solidly resist food industry pressure to underinform or misinform consumers, in violation of the statute and the FDA’s moral responsibility.
1. THE FOOTNOTE ISSUE
In 2002, the National Academy of Science’s Institute of Medicine issued a report entitled Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein and Amino Acids (hereinafter the “NAS Report). The NAS Report’s conclusion was as follows:
Based on the NAS Report, the FDA proposed in November 2002 that instead of a Daily Value, an asterisk would be placed on the right-side of the trans fat line of the Nutrition Facts panel directing the consumer to the following footnote:
INTAKE OF TRANS FAT SHOULD BE AS LOW AS POSSIBLE.
In July 2003, the FDA abandoned its position saying that “the overwhelming majority of comments opposed the use of the footnote.” [Fed. Reg., Vol. 68, No. 133, July 11, 2003 at page 41452.] It would appear that the FDA may have been swayed by the number of comments rather than the contents of those comments. The food industry is obviously far better prepared to flood the FDA with comments than the unorganized and uninformed public. The FDA should be concerned with what people say, not how many people say it.
The FDA, in its ANPR, has now invited public comments on six footnote options. We discuss each in turn.
FDA FOOTNOTE OPTION ONE
INTAKE OF SATURATED FAT AND TRANS FAT SHOULD BE KEPT LOW WHILE MAINTAINING A NUTRITIONALLY ADEQUATE DIET.
A. We object to the omission of the words “as low as possible.” Those words were drawn directly from the NAS Report and are not in any way confusing. They are supported by the comprehensive and solid medical and statistical evidence cited in the NAS Report. The message is totally valid: try to avoid trans fat if you can.
The argument that the words “as low as possible” would result in consumers steering away from products containing naturally-occurring trans fatty acids is a red herring. The problem is not naturally-occurring trans fatty acids. The problem is partially hydrogenated oils. Adding the words “while maintaining a nutritionally adequate diet” would send an appropriate message to consumers that they should adopt a balanced diet and not take extreme actions which might compromise their health.
B. The word “low,” standing alone, is meaningless. It begs the question – how much is “low”? “Low” can only be understood in relation to quantifications of “low” and “high.” “Low” could be 2 grams, 10 grams, or 50 grams. Consumers will not find the word “low” helpful in any way. The statute requires the FDA to establish labeling which advises consumers of the “relative significance” of nutrient information “in the context of a total daily diet.” The word “low” standing alone does not convey “relative significance” at all.
C. The purpose of the footnote is to compensate for the fact that there would be no percentage Daily Value on the trans fat line. There is a percentage Daily Value for saturated fat and therefore no need for a footnote about saturated fat.
D. We are very concerned with, and would object to, identification of trans fat with saturated fat. We need only look to the FDA’s own findings in support of the Final Rule on trans fat labeling in July 2003 for support:
The wording of Option One would equate trans fat and saturated fat in the minds of consumers, and would lead many consumers to believe that they are exactly the same. However, as the FDA acknowledged, trans fat is chemically distinct from saturated fat. The FDA found that the association of trans fat and saturated fat would mislead consumers. We agree.
FDA FOOTNOTE OPTION TWO
INTAKE OF TRANS FAT SHOULD BE KEPT LOW
See Comments A and B on Option One.
FDA FOOTNOTE OPTION THREE
INTAKE OF SATURATED FAT, TRANS FAT AND
See Comments A, B, C and D on Option One.
A. We believe that addition of the word “cholesterol” adds even more confusion. As the FDA has pointed out, associating trans fat and saturated fat in the minds of consumers is misleading. Associating a third element, cholesterol, only compounds the problem.
FDA FOOTNOTE OPTION FOUR
AS PART OF A NUTRITIONALLY BALANCED DIET,
See Comments A, B, C and D on Option One and Comment A on Option Three.
A. We object to Option Four because it makes it appear that trans fat is a beneficial and necessary part of a nutritionally balanced diet. The message is so perverse that consumers could be expected to try to increase trans fat input. Trans fat is not a necessary part of any diet. It has no known beneficial effects. The FDA found as follows:
FDA finds that the intervention and observational studies provided strong evidence of both a causal relationship between trans fat intake and risk of CHD and applicability to the general U.S. population. [Fed. Reg., Vol. 68, No. 133, July 11, 2003 at 41446.]
FDA FOOTNOTE OPTION FIVE
HEALTHY DIETS START WITH DIETS LOW IN
See Comments A, B, C and D on Option One, Comment A on Option Three, and Comment A on Option Four.
A. We object to Option Five because it makes it appear that trans fat is “healthy” and a necessary part of a nutritionally balanced diet. It sounds like an advertisement for trans fat.
FDA FOOTNOTE OPTION SIX
NUTRITIONALLY ADEQUATE DIETS INCLUDE DIETS LOW IN SATURATED FAT, TRANS FAT, AND CHOLESTEROL.
See Comments A, B, C and D on Option One, Comment A on Option Three, Comment A on Option Four, and Comment A on Option Five.
OUR PROPOSED FOOTNOTE OPTIONS
Our proposed footnote options, in order of preference, are as follows:
OUR FOOTNOTE OPTION ONE
INTAKE OF TRANS FAT SHOULD BE AS LOW AS POSSIBLE.
[The footnote could be omitted when there is no partially hydrogenated oil whatsoever in the product.]
This is the footnote that the FDA has apparently rejected. Nevertheless, it is clear, concise, and valid. It is based on the NAS Report. We strongly urge the FDA to reconsider its rejection of this wording. The words “as low as possible” are an essential part of any footnote. We believe that the words “as low as possible” are legally required in view of the FDA’s findings about the dangers of trans fat and the NAS Report.
The food industry is expressing “concern” that consumers will avoid meat and dairy products because they contain naturally-occurring trans fat. We believe that this “concern” is bogus. However, the FDA could allow the footnote to be omitted when there is no partially hydrogenated oil whatsoever in the product.
OUR FOOTNOTE OPTION TWO
THIS PRODUCT CONTAINS PARTIALLY HYDROGENATED OIL. INTAKE OF TRANS FAT FROM SUCH OILS SHOULD BE KEPT AS LOW AS POSSIBLE.
[The footnote could be omitted entirely when there is no partially hydrogenated oil whatsoever in the product.]
This wording would address any concern about consumers avoiding meat and dairy products because they contain naturally-occurring trans fat. It would also inform consumers about the connection between partially hydrogenated oils and trans fat, which is a positive and important educational step.
OUR FOOTNOTE OPTION THREE
INTAKE OF TRANS FAT SHOULD BE KEPT AS LOW AS POSSIBLE WHILE MAINTAINING A NUTRITIONALLY ADEQUATE DIET.
This option is far less preferable than our other two options. Our concern with this option is that it seriously dilutes, weakens and confuses the message about trans fats. However, if adding the words “while maintaining a nutritionally adequate diet” is the price that we have to pay to obtain acceptance of the words “as low as possible,” then as a matter of practical politics it may be a price worth paying.
2. TRANS FAT-FREE CLAIMS
We have received more e-mail about products that list a partially hydrogenated oil in the ingredients, but show zero grams of trans fat or claim to be trans fat-free, than any other subject. We have now taken steps to make sure that visitors to our website clearly understand that the law provides that if a product contains less than 0.5 grams of trans fat, the content must be expressed as zero, except when the statement “Not a significant source of trans fat” is used.” It is unfortunate that they have to rely on our website to clear up their understandable confusion.
We are not concerned with fine and meaningless distinctions between stating that a product has zero grams of trans fat and claims that it is trans fat-free. As far as the consumer is concerned, they mean exactly the same thing – that the product contains no trans fat. We are not confident that the FDA appreciates this point.
We are surprised and puzzled at the FDA’s issuance of the rule requiring rounding down to zero, because it is totally inconsistent with the following findings made by the FDA as the basis for the Final Rule:
The FDA in its Final Rule is requiring that if the serving contains less than 0.5 gram, the content, when declared, shall be expressed as zero. This makes no sense at all in view of the FDA’s findings. It is misleading, arbitrary and capricious, and violative of the statute.
Here are some of the unsolicited e-mails that we have received from the public on this subject:
The public needs to have this issue clarified, on the label. Therefore, we propose that the following statement be added at the beginning of the footnote whenever partially hydrogenated oils are listed in the ingredients, but the trans fat content is shown as zero grams:
This proposed wording will clearly inform the public and should prevent them from being misled. It is a necessary corrective measure. It is based on the FDA’s own finding that “consumption of several foods, each with 0.5 to 1 g trans fat per serving, over the course of a day may result in a significant overall trans fat intake for the day.” [Fed. Reg., Vol. 68, No. 133, July 11, 2003 at 41451 (emphasis added.).]
“Trans fat-free,” “zero grams of trans fat,” or substantially similar claims, claims should be prohibited whenever any trans fat is present.
3. THE TIMING ISSUE
The current state of affairs is that food manufacturers are permitted to state the trans fat content of their products on the Nutrition Facts panel, with a blank space instead of a Daily Value. This is a dangerous situation, because consumers are very likely to interpret this as meaning that they can consume unlimited amounts of trans fat without any adverse consequences. It is also, unquestionably, a violation of the statutory requirement that the “relative significance” of the trans fat content be stated. Therefore, we request that the FDA move forward with a Proposed Rule and the Final Rule as soon as possible. Delay is costing lives.
Finally, we quote the FDA once again:
The FDA’s decisions on trans fat labeling will affect consumers for many years to come, probably decades. Millions of lives will be affected by the FDA’s decisions on what goes on the label. People will suffer heart attacks and die unnecessarily if the FDA breaches the public trust and makes the wrong decisions.
We strongly urge the FDA to act only in the best interests of the consumer and not allow itself to be swayed by bogus concerns expressed by the food industry that are designed to prevent consumers from receiving the information that they need.
Stephen L. Joseph
Chief Executive Officer