Issues New Policy Statement Concerning Health Claims on Dietary Supplements
Engages in Regulatory Origami
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.
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.”
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
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.
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.
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.
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.
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
Zackler & Associates
can advise you concerning utilization of the new FDA policy to
expand marketing opportunities for your food and dietary supplements.
Disputes FDA’s Proposed Trans Fat Warning Label
Future Is Here Now
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.
Asks for Comments on Commercial Speech Issues
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
the FDA has not limited its request to any specific topics, it has
listed several areas of particular interest in the notice including:
should be the standards for speech pertaining to drugs?
FDA change its policies concerning direct advertising of drugs to
the FDA has different regulations for nutritional claims for food
and dietary supplements?
should the disclaimers be presented relative to the claims they modify?
should warnings be stated?
there any empirical evidence to support different standards for on
and off label claims?
public statements by persons in a drug distribution channel concerning
off-label uses undermine the FDA’s authority to approve new
the FDA speech related regulations address the public health?
the FDA change any of its regulations in order to comply with First
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
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.
Moves to Eliminate Frozen Meat Pizza Standard of Identity
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.
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.
ISSUES WARNING OVER LIPOKINETIX
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.