To: IAHF List
Subject: FDA Proposes New Health Claims Procedure-(Free Speech Victory/Simultaneous with FDA Counterattack
From: IAHF.COM
Date: 14 Jul 2003 15:37:00 -0000

IAHF List: Below I'm sending two press releases on the same topic, and its interesting to compare and contrast them. The first of the two provides a supplement industry perspective on the FDA's new "grading system" for health claims made on product labels.

[FDA will now be allowing qualified health claims on dietary supplements, and on food labelling, which they will be giving "report card like" letter grades to signifying their view on the legitimacy of the claim on a basis of how much scientific evidence they feel backs it up. Their grades will run from A-F.

The first perspective (show belown in the Natural Products Insider press release) is that the FDA's new plan is a GOOD thing, because it shows they're willing to abide by the first amendment (which for you non Americans guarantees us freedom of speech).

Attorney Jonathan Emord comments that this is a "move in the right direction" (because it indicates that FDA is making an effort to comply with the law in the aftermath of losing in Pearson v Schalala wherein the FDA was ordered by the court to stop blocking the dietary supplement industry from making truthful health claims on product labels.

I share Emord's view, because I take everything FDA says with a serious grain of salt. They might give a claim a "D" or an "F" because they consider certain scientific studies to be somehow "illigitimate" that I might consider to be VERY legitimate- because of a totally different perspective on the science. So I don't really CARE what letter grade FDA puts on these labels to go with the claim, as long as they don't block my access to health information.

I can check out the claim myself, on my own, and decide how much credence I think it deserves, and I don't care if FDA wants to put a skull and crossbones on the damn product, or anything else as long as they don't block my access to the information. I do see a threat lurking in this, however: FDA plans on using the Agency for Healthcare Quality and Research (AHRQ) to review these claims. They are under contract to the FDA, and are very biased against dietary supplements.

One of these AHRQ "reviewers", Charles Morrow who is under NIH contract at Oregon Health Sciences University, has been needling me with taunts that "DSHEA's days are numbered" and he's been sending me a lot of junk science "studies" which supposedly "prove" the "danger" and "ineffectiveness" of dietary supplements. These "studies" are being published in mainstream peer reviewed journals (underwritten by pharmaceutical advertising), and they're getting a lot of mainstream press coverage in newspapers---- Jonathan Emord better not ignore this....

While the SECOND PERSPECTIVE (undoubtedly shared by the FDA and the AHRQ) is that this is NOT a good thing- (they say it "misleads" the public) and it provides the perspective of the anti Dietary Supplement Health and Education Act (DSHEA) crowd including that of so called "Center for Science in the Public Interest" and other critics.

MOST SIGNIFICANTLY, the SECOND perspective was aired before the LARGEST AUDIENCE of these two perspectives (ABC News), and THAT is NOT a good thing, as it puts momentum behind FDA's efforts to try to condemn supplements as "dangerous and unproven- in need of safety and efficacy testing" as they try to come out with Good Manufacturing Practice (GMP) regs that violate the law in an ongoing effort harmonize the USA to the EU and to Australia via GMPs.... (FDA is taking a very broad interpretation of DSHEA as they try to engage in Mutual Recognition Agreements pertaining to GMPs and set us up that way for the scuttling of our dietary supplement laws via harmonization with the EU- more on that in another mssg.

In the second perspective, the comments of Lichtenstein (researcher from Tufts, a pro pharma, anti DSHEA entity are ominous and telling- FDA intends to use this "report card" as a way to attack the supplement industry to try to set up passage of Durbin's bad bill S.722 (The Dietary Supplement Safety Act). Lichenstein says the FDA would like to "potentially modify the system on the basis of what is learned." (Thats code for attack us indirectly by setting us up for a Media Circus via AHRQ junk science massively spread via the wire services after they receive "news articles" generated by the FDA's own press office....)

FIRST PERSPECTIVE

http://www.naturalproductsinsider.com/hotnews/37h10162738.html

FDA Proposes New Health Claim Procedures

Posted on: 07/10/2003

WASHINGTON--The Food and Drug Administration (FDA) came up with a game plan for health claims appearing on dietary supplements and food. On July 10, FDA's Task Force on Consumer Health Information for Better Nutrition (http://www.fda.gov/oc/mcclellan/chbn.html) unveiled a new process to provide more science-based, FDA-regulated information about the health consequences of foods and dietary supplements on product labels.

The task force, made up of government experts on health information and nutrition from FDA, the Federal Trade Commission (FTC) and the National Institutes of Health (NIH), proposed a two-phase plan--which includes the steps companies should take for getting a health claim approved--to improve consumer understanding of the health consequences of their dietary choices.

FDA intends to use the interim procedures to ensure that its pre-market review is consistent with the spirit of the Nutrition Labeling and Education Act (NLEA) and the First Amendment.

"Protecting consumers by helping them get better nutrition information is among FDA's top priorities, because the choices that Americans make about their diet have a great impact on the health of the public," said FDA Commissioner Mark B. McClellan, M.D., Ph.D. "This new initiative will better protect consumers from making uninformed or misinformed choices about their diet and nutrition, by giving consumers better information about the health consequences of those choices."

He added the review process for making qualified claims, combined with FDA enforcement, will reward companies that make healthier products while more aggressively enforcing the law against companies that appeal to consumers through false and misleading health claims.

In support of the task force's efforts, FDA made available two final guidance documents in the June 10 Federal Register. The first, "Guidance: Interim Procedures for Qualified Health Claims in the Labeling of Conventional Human Food and Human Dietary Supplements," explains how applicants can seek a qualified health claim for food or dietary supplements during the first phase of this initiative. It also describes how FDA will set priorities for reviewing qualified health claims petitions most likely to have important public health benefits.

The second document, "Guidance: Interim Evidence-based Ranking System for Scientific Data," describes a process for systematically evaluating and ranking the scientific evidence for a qualified health claim. This ranking system will categorize the quality and strength of the scientific evidence. For example, grades of "B," "C" or "D" will be given to every proposed, qualified health claim.

The highest grade, "A," indicates significant scientific agreement about the health claim. Evidence supporting said claim will be based on well-designed studies conducted in a manner consistent with generally recognized scientific procedures and principles. Such a claim requires no disclaimer and is therefore referred to as an "unqualified health claim." A current example of an "A" health claim, according to FDA, would be calcium's benefits for osteoporosis.

Health claims graded "B," "C" or "D" are referred to as "qualified health claims"; they require a disclaimer or other qualifying language to ensure they do not mislead consumers. A "B" grade would be assigned to those petitions for which there is good scientific evidence supporting the claim, but for which the evidence is not entirely conclusive. FDA reported claims such as omega-3s' link to cardiovascular health would fall under this heading. A "C" grade would apply to claims for which the evidence is limited and inconclusive, while a "D" grade would be given to claims with little scientific evidence to support them. More on the ranking system can be found on FDA's site (http://www.fda.gov/OHRMS/DOCKETS/98fr/03N-0069-gdl0001.pdf).

The agency intends to begin applying these interim guidances for health claim petitions submitted on or after Sept. 1, 2003. Within 45 days of receipt of a qualified health claim petition, FDA intends to determine whether the petition is complete; once it is, the agency intends to file the petition. FDA recognizes that it can evaluate petitions more efficiently and effectively if they are well-organized and contain all the relevant information. FDA encourages potential petitioners to meet with the agency prior to preparing a petition to discuss their plans.

FDA plans to prioritize claims on a case-by-case basis, factoring in whether the food or dietary supplement that is the subject of the petition is likely to have a significant impact on a serious or life-threatening illness; the strength of the evidence; whether consumer research has been provided to show the claim is not misleading; whether the substance of the claim has undergone an FDA safety review (i.e., is an authorized food additive, has been self-affirmed GRAS [generally recognized as safe]); whether the substance that is the subject of the claim has been adequately characterized so that the relevance of available studies can be evaluated; whether the disease is defined and evaluated in accordance with generally accepted criteria established by a recognized body of qualified experts; and whether there is prior review of the evidence or the claim by a recognized body of qualified experts.

Upon filing a petition, FDA intends to post the petition on its Web site and request public comment for 60 days.

After the comment period closes, FDA may pursue any one of several options for scientific review of data submitted in a petition in support of the substance/disease relationship. FDA may conduct the review internally, it may convene an advisory subcommittee, or it may use appropriate third-party reviewers under contract to FDA, such as the Agency for Healthcare Quality and Research (AHRQ).

On or before day 270 after receipt of the filed petition, FDA plans to notify the petitioner in a letter of: a) the agency's determination; b) the basis for its determination; and c) if the agency decides to consider exercising enforcement discretion, the qualified claim for which the agency intends to consider exercising such discretion and the provisions of 21 CFR 101.14 for which the agency intends to consider exercising such discretion. FDA also plans to notify the petitioner of any other factors the agency intends to consider in deciding whether to exercise enforcement discretion when the claim appears in labeling of conventional human food or dietary supplements.

FDA is conducting further consumer research to make sure that the language used is easily and accurately interpreted by consumers. FDA will also complete, and encourage other research groups to complete, a consumer studies research agenda designed to improve understanding of the most effective way to present scientifically based, truthful and non-misleading information to consumers--as well as identify the kinds of information known to be misleading.

According to Joseph Levitt, director at FDA's Center for Food Safety and Applied Nutrition (CFSAN), "If companies do their own consumer research data, that would be one criteria that would help move them further along to the front of the line."

In support of this new measure, FDA has refocused its Applied Nutrition programs in its Center for Food Safety and Applied Nutrition, to provide additional resources for, and senior staff involvement in, the "Consumer Health Information for Better Nutrition" initiative. For example, FDA has established new policy expert positions in the Office of the Commissioner on nutrition, risk management and risk communication to assist in these applied nutrition activities. FDA is also establishing closer ties between its dietary supplement program and the experts in its drug program who have extensive professional knowledge of the medical risk factors for various diseases. Plus, FDA is enhancing its enforcement activities related to misleading claims about the health benefits of products, particularly dietary supplements, that are not supported by scientific evidence.

These moves are part of FDA's effort to implement the Pearson v. Shalala court decision that found FDA could not reject health claims unless the claims were both misleading and that no disclaimer would clear the misunderstanding. In 2002, the FDA was challenged by the judicial system for violating the protection afforded to company claims proffered under the First Amendment. As a result, FDA issued a request for public comment in the May 16, 2002, Federal Register as to what its boundaries should be for limiting commercial speech.

"This process is one that will allow us to get a handle on the recent series of court losses related to the times FDA has said a claim cannot be allowed rather than letting it go forward with the appropriate qualification," McClellan said during the June 10 conference. "There may be things we learn from this process that we can relate to structure/function claims. We'll see."

McClellan admitted it may be a long shot for a claim to get an "A" rating. "It's hard to get above a B claim and we haven't seen many claims come in at that level in the last decade because the evidence standard is high and it's hard to do that level of research on food nutrition," McClellan told INSIDER. "However, that's why we think it's important to give people access to the information that's been developed by nutritional science over the past decade. If health claims are already out there, they're fine." Those health claims already established, such as soy for heart health and fiber for cholesterol levels, are already considered "A" claims, he added.

Industry Comment

Not since FDA's Good Manufacturing Practices (GMPs) came out in March has there been such a stir in the industry. For one, the Grocery Manufacturers of America (GMA)--reportedly the ones to propose this pre-market notification system in May 2003--was pleased with FDA's actions. "The ability to use qualified health claims by the food industry will provide food manufacturers with new incentives to develop and market new, healthier-for-you products," said Alison Kreser, R.D., director of scientific and nutrition policy.

David Seckman, executive director of the National Nutritional Foods Association (NNFA), found FDA to be moving in the right direction. "These proceducres will allow the manufacturer to provide more accurate and relevant information to consumers. That's a definite plus, both for the consumers and the manufacturers. FDA's health claim procedure clearly supports an industry like ours."

It still remains to be seen how the new health claim procedure will affect the well-being of the industyr. At the 12th Annual Conference of the Functional Foods for Health Program, held at the University of Chicago, Ill., Peter Barton Hutt of the law firm Covington & Burling (http://www.cov.com), spoke at length on FDA's proposed health claim process. In particular, he made mention of FDA's wording for its grading system: "The Constitution does not say that FDA can create its own dictionary."

Jonathan Emord of Emord Associates P.C. (http://www.emord.com), an industry-recognized expert in health claim petitions, saw this announcement as a "good thing." "The commissioner has made a bold move in the right direction to ensure American consumers get more and more accurate information about nutrients on disease," he said. "The FDA can characterize the relevant level of [a claim's] strength as scientists see it as long as those characterizations are reasonable. The critical factor is that people get more of this cutting-edge information about the effects of different nutrients on disease. Some of it's well-established, some of it's preliminary--but all of it should be available to the public to assess."

SECOND PERSPECTIVE

ABCNEWS.com : FDA Plans to Grade Product Health Claims http://abcnews.go.com/sections/living/US/labelgrades030710.html

Making the Grade


New System to Evaluate Health Claims on Food and Diet Supplements


By Susie L. Morris

July 10 Teachers won't be the only ones issuing grades from now on. The Food and Drug Administration plans to start grading health claims on product labels.

The ranking system will assign letter grades ranging from "A" to "D" on each claim a company makes, indicating the quality and strength of the scientific evidence that supports the claim.

"We want to see more of a focus on getting that information out to consumers and we want to see more of a focus on food producers competing based on the health consequences of their products," says FDA Commissioner Dr. Mark McClellan.

The measure is intended to encourage the manufacturers of foods, beverages and dietary supplements to present only health claims that are firmly backed by sound science. An FDA spokesperson said the new grades are intended to inform consumers about the products they buy.

But consumers won't see the changes right away. "The new regulations take effect in September, but it'll likely be months after that before consumers see any change in their food labels," reports ABCNEWS correspondent Lisa Stark.

Health Claim Report Card

Under the new plan, an "A" grade will be assigned to claims supported by many well-designed studies. For instance, if a food high in fiber boasts the ability to one's reduce risk of colon cancer, the claim will be given an "A" since the link between fiber and gastrointestinal cancers has been well established by scientific research.

Health claims with "good" but not entirely "conclusive" supporting evidence will be assigned a "B" designation. Label statements made with little or no conclusive evidence to back them up will fall into "C" and "D" categories.

This new proposal does not censor the health claims; rather, it retains claims while noting their strength. The measure might have been prompted by the 1999 court decision, Pearson v. Shalala, which requires the FDA to permit all truthful and non-misleading health information on herbal supplement labels, says Dr. Alice Lichtenstein, director and senior scientist at the Cardiovascular Nutrition Laboratory at Tufts University in Medford, Mass.

"The system is an excellent approach," says Dr. David Katz, director of Yale University's Prevention Research Center in New Haven, Conn.

Katz says the program will be particularly helpful because consumers are becoming increasingly responsible for reaching their own health-care decisions, which may often be based on direct-to-consumer advertising. This initiative would provide consumers with information in a recognizable way so that they are informed about what it is they are buying.

A changing and flexible grading system can also mirror the advances made in science as new health claims are studied and explored, adds Lichtenstein. Consumers could therefore be kept up to speed on the latest scientific evidence and what they are buying.

Noralyn Wilson, a registered dietitian and spokeswoman for the American Dietetic Association, believes consumers will be well-protected by this particular measure, particularly people who consume dietary supplements. "The FDA is just trying to get its arms around it [the dietary supplement industry]," she says.

Consumer Concern

Currently, only health claims proven conclusively through science are printed on product labels. Some experts say that this new measure is a step in the wrong direction.

"Today's FDA action lowers the standard for making health claims and it means that health claims on food packages will be less reliable. The agency is presenting a marketing advantage to the food companies at the expense of consumer welfare," says Bruce Silverglade of the Washington-based Center for Science in the Public Interest.

"I think the grading system is going to make American shoppers even more confused about nutrition," says Jeffrey Hampl, a registered dietitian at Arizona State University in Mesa. "Shoppers won't be paying close attention to the A, B, C or D. They'll see the health claim and base their decision to buy on that."

Other experts assert that a passing out letter grades may not be so easily applied to health promises as it is to students, and believe that only claims for which there is sound scientific proof should be allowed on labels.

"No more fables on labels, please," says Dr. Keith-Thomas Ayoob, associate professor of nutrition at Albert Einstein College of Medicine in New York. He contends that because claims receiving "C" and "D" statements are not sufficiently backed by scientific research, they simply have no place on a product label.

Although expert opinions are mixed, all agree that consumers deserve to be informed. "[We] need to focus resources in answering these uncertainties," says Lichtenstein, "and potentially modify the system on the basis of what is learned."

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