FDA & USDA Related Articles

FDA Issues New Policy Statement Concerning Health Claims on Dietary Supplements and Food

Agency Engages in Regulatory Origami

In a new effort to comply with the District of Columbia Court of Appeals decision in Pearson v. Shalala the FDA has issued a new policy statement concerning “qualified” health claims that can be put on the labels of dietary supplements and food products. In Pearson the Court held that the First Amendment limited FDA’s regulation of truthful health claims on the labels of dietary supplements.

Essentially, the FDA’s new policy has created a category of “enforcement discretion” for health claims that do not meet the FDA’s existing requirement that health claims be substantiated by “significant scientific agreement.” The new category is based on the “weight of the scientific evidence”. The FDA’s policy describes this test as: “The test is not whether the claim is supported numerically (i.e., whether more studies support the proposed claim than not), but rather whether the pertinent data and information presented in those studies is sufficiently scientifically persuasive.”

In order to trigger enforcement discretion, the health claim must be submitted to the FDA through its existing petition process for health claims. Presumptively, the FDA will exercise (non-) enforcement discretion, if it determines that although the claim is not supported by “significant scientific agreement,” it is supported by the weight of the scientific evidence. The FDA has reserved the right to later exercise enforcement discretion against a health claim if it determines that the weight of subsequent scientific evidence shifts against the claim.

Don’t rush to file your petition with the FDA. The Office of Nutritional Products, Labeling and Dietary Supplements, which will be administering the program, has stated that qualified claims will not be reviewed by the agency until an implementation phase is completed that could take as long as six months.

This rather peculiar policy is based on the FDA’s position that the FD&C Act only allows it to approve health claims that meet the significant scientific agreement test and therefore, the FDA cannot “approve” health claims that a meet a lesser standard.

It remains to be seen whether this new policy will satisfy the plaintiff’s contention that prior FDA initiatives failed to comply with the requirements of Pearson. Even if the policy itself meets Pearson’s requirements, there will probably be issues whether the FDA is honestly administrating the new policy. We expect more visits to the courthouse before this is all over.

The FDA’s new policy also stated that it is adopting the FTC’s “reasonable consumer” standard for determining whether a claim is misleading instead of the statutory “misleading in any particular” standard. We’ll have to wait and see how the FDA interprets this new standard and what effect, if any, it has on FDA enforcement actions. However, it’s a very good bet that your marketing department's definition of a reasonable consumer won't be the same as the FDA's.

Meanwhile, the FDA has approved a new health claim for products with D-tagalose, which is commonly called tagalose. Tagalose has been added to the “does not promote tooth decay” health claim that the FDA has already approved for products sweetened with sugar alcohols such as sorbitol. As with many FDA regulations there is a catch. Because tagalose is classified as a sugar, products that contain it cannot be labeled as “sugar free.” On the other hand, products which contain tagalose will not have to list their sugar alcohols content in the Nutrition Facts. The amended regulation approving the new health claim for tagalose contains several examples of model claims.

Zackler & Associates can advise you concerning utilization of the new FDA policy to expand marketing opportunities for your food and dietary supplements.


Industry Disputes FDA’s Proposed Trans Fat Warning Label

The Future Is Here Now

Speaking of a food labeling future of warning labels, in the Summer 2002 issue of Food Law Update we commented on a National Academy of Sciences study that concluded the DV for trans fatty acids should be “0” and on the proposed FDA trans fat labeling rule. In that issue we predicted that nutritional warning labels would be the trend of the future. Well, the future is here now. The FDA’s proposed trans fat labeling rule not only requires listing the amount of trans fat in a product, it would also require the Nutrition Facts box to have a footnote in 10 point type stating: “Intake of trans fat should be as low as possible.” Industry reaction to this proposal is not favorable. It has criticized the proposal as likely to cause consumers to substitute for products that are high in saturated fat, for which no warning is required and the corresponding reformulation of products by food processors. Public interest advocates of the proposal want the warning expanded to include saturated fat. The FDA is expected to issue its final rule this summer.


FDA Asks for Comments on Commercial Speech Issues

Although it appears that the California Supreme Court majority in Kasky v. Nike needs a remedial course in Constitutional Law, the FDA appears to be at least willing to learn. Citing the United States Supreme Court decision in Thompson v. Western States Medical Center, which held that the FDA could not restrict otherwise truthful advertising of compounded drugs, the FDA has issued a Federal Register Notice requesting comments concerning its regulation of commercial speech.

Although the FDA has not limited its request to any specific topics, it has listed several areas of particular interest in the notice including:

What should be the standards for speech pertaining to drugs?

Should FDA change its policies concerning direct advertising of drugs to consumers?

Should the FDA has different regulations for nutritional claims for food and dietary supplements?

How should the disclaimers be presented relative to the claims they modify?

How should warnings be stated?

Is there any empirical evidence to support different standards for on and off label claims?

Do public statements by persons in a drug distribution channel concerning off-label uses undermine the FDA’s authority to approve new uses?

Do the FDA speech related regulations address the public health?

Should the FDA change any of its regulations in order to comply with First Amendment requirements?

The FDA has extended the comment period to September 13, 2002 any responses to those comments are to be submitted by October 28, 2002.

After its losses in Thompson as well as Pearson v. Shalala, the FDA has apparently become much more sensitive to First Amendment claims and now wants to develop a factual matrix to either support its restrictions or modify its advertising restrictions so they pass muster as the least intrusive method of protecting the public. This notice represents a great opportunity to go on record with the FDA concerning any advertising regulations that fail to protect the public welfare in the most legally appropriate manner.

Zackler & Associates can review any FDA regulations that impair the truthful advertising of any goods or services offered by your business and prepare a statement for submittal to the FDA.


USDA Moves to Eliminate Frozen Meat Pizza Standard of Identity

The USDA has set January 2, 2002 as the last day to submit public comment on its proposal to eliminate its decades-old “standard of identity” for frozen meat pizza. Under the current USDA rules, a frozen meat pizza product must have a crust, cheese, a tomato based sauce and at least 10% meat by weight in order to be labeled as pizza. If the standard of identity is eliminated, frozen meat pizzas could then contain as little as 2% meat, the current USDA minimum content required for anything labeled as a meat product.

Assuming USDA goes forward with its plan to eliminate these rules, pizza makers could reduce the amount of meat and experiment with different toppings such as pesto or alfredo sauce. Frozen pizzas that contain no meat are subject to regulations from the Food and Drug Administration. The FDA does not set standard of identity rules for meatless pizzas, allowing manufacturers more freedom in experimenting with different toppings and styles. Neither the USDA nor FDA has jurisdiction over restaurant or delivery pizzas.



The FDA has warned consumers to immediately stop using the dietary supplement Lipokinetix®, marketed by Syntrax Innovations, Inc. The warning was issued after FDA received multiple reports of liver damage from consumers who were taking the supplement. Lipokinetix is marketed as a weight loss product. Its contains the ingredients norephedrine, caffine, yohimbine, diodothyronine and sodium usniate. All reported liver injuries appeared in consumers between the ages of 20 and 32. Onset of damage took as long as three months to occur. Symptoms included nausea, weakness or fatigue, abdominal pain or any change in skin color.