Adopts New Procedures for Submittal of "Qualified" Health
Approves Qualified Claims for Nuts
reported in the Winter 2003 issue of Food & Marketing Law Update,
the FDA has been in the process of developing procedures to “approve”
qualified health claims for use on both foods and dietary supplements.
Although the FDA won’t admit it, these changes are apparently
in response to the court orders in the Pearson v. Shalala case which
was a successful First Amendment challenge to the FDA’s limitation
on bona fida, on-label health claims.
The regime divides label health claims into four categories:
Support for Claim
is not conclusive.
there is scientific evidence supporting the claim, the evidence
is not conclusive."
is limited and not conclusive.
scientific evidence suggest...however, FDA has not determined
that this evidence is limited and not conclusive."
scientific evidence supporting claim.
limited and preliminary scientific research suggests...FDA
concludes that there is little scientific evidence supporting
A claims are the legislatively authorized claims under the NLEA
which are subject to a rule making process and once approved
are published in the Code of Federal Regulations (“CFR”).
For more information about currently approved Rank A health claims
see Title 21, subpart E of the CFR. The other claims are not
legislatively authorized and therefore will be approved through
a non-rule making process.
September 1, 2003 the FDA will begin accepting petitions for qualified
health claims. The petitions will be prioritized on such factors
as whether the food or dietary supplement is likely to have a significant
impact on serious illness and the strength of the evidence supporting
the claim. After a 45-day internal review period the FDA will then
post the petition for a 60-day public comment period. After the
close of the comment period, the FDA can conduct its own review.
Within the next 165 days (i.e. within 270 after filing the petition),
the FDA will notify the petitioner of its determination.
FDA will use a six step interim process in evaluating the scientific
support for the health claim. These evaluation steps include (a)
the relationship between a nutrient and disease, (b) the identification
of individual studies concerning this relationship (c) classification
of the studies based upon study design type, (d) designation of
study quality (e) ranking of the scientific evidence (i.e., A. B,
C or D) and (f) reporting the rank. While using this interim procedure,
the FDA intends to continue reviewing the inclusion of qualified
health claims in its normal rule making process.
Approves Qualified Claims for Nuts and Coronary Heart Disease
FDA identified four “fast track” health claims for
approval. These claims are for (i) omega-3 fatty acids reducing
the risk of heart disease, (ii) consumption of fruits and vegetables
reducing cancer and chronic illness risk, (iii) reducing the risk
of heart disease by using vegetable oils containing unsaturated
fats in place of solid fats and (iv) reducing the risk of heart
disease by using nuts as a replacement for proteins containing
July 14, 2003 the FDA approved a qualified coronary heart disease
(“CHD”) prevention claim for walnuts and other nuts
based upon a petition by the California Walnut Commission. However,
the approved qualified claim is different from the claim requested
by the Commission. The Commission had petitioned FDA to use the
claim “Diets including walnuts can reduce the risk of heart
disease.” The FDA rejected this proposal because the FDA concluded
that there is not significant scientific agreement regarding walnut
consumption and a reduced risk of CHD. Instead, the FDA has approved
the following qualified claim: “Supportive but not conclusive
research shows that eating 1.5 ounces per day of walnuts as part
of a diet low in saturated fat and cholesterol may reduce the risk
of heart disease. See nutrition information for fat content.”
At the same time, FDA also approved a wider claim that consumption
of peanuts and several kinds of tree nuts will reduce the CHD risk.
Note the FDA has prescribed specific language on how each claim
is to be stated and has imposed additional disclosure requirements
and limitations on the claims’ use.
Added to List of Nutrients That Can Make Health Claim for Fiber
and Coronary Heart Disease
response to a long standing petition from the Quaker Oats Company,
the FDA has approved a modification of the existing conventional
(non-qualified) health claim linking the consumption of soluble
fiber to a reduced risk of coronary heart disease. Effective immediately
foods containing oatrim (more technically known as alpha-amylase
hydrolyzed oat bran) may make this claim if they meet all of the
other requirements in the regulation.
Begins Implementation of Bioterrorism Act
Everyone in the Food Business Will Be Affected
January 29, 2003 the FDA published Federal Register notices for
two sets of proposed rules to implement two of the four required
FDA mandates in the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 (the “Bioterrorism Act.”).
The requirements of these four mandates will fundamentally affect
the business practices of many domestic and foreign firms that
sell food (including dietary supplements) in the United States.
two published notices are for rules that (a) require, with certain
exceptions, the registration with the FDA of every domestic and
foreign facility that processes, packs or stores food that is sold
in the US and (b) require prior notice to the FDA of every shipment
of food imported into the US. The FDA intends to have these rules
finalized and its internet based 24/7 registration and import notice
systems operational by October 12, 2003. Any person or firm who
fails to register a covered facility by December 12, 2003 or who
imports of food into the United States after December 12, 2003 without
providing prior notice to FDA will be in violation of the act and
subject to civil and criminal sanctions.
FDA has delayed until at least April the publication of the proposed
rules to implement the two other mandates in the Bioterrorism Act.
One mandate requires that all businesses that manufacture, process,
pack, transport, store, or import food into the United States keep
a paper trail of all suppliers of the food and the persons to whom
the food is sold. We anticipate that these rules will require food
manufacturers and processors to keep batch-by-batch records of the
sources of ingredients used to make their products. This rule must
also be effective no later than December 12, 2003.
fourth mandate gives the FDA new authority to administratively detain
(i.e. without court order) any food that the agency has evidence
or information that the food presents a threat of a serious adverse
health consequence to either humans or animals. The legislation
mandating this rule does not require any association with terrorist
threats or activity. There is no deadline for implementation of
two proposed rules that have been published by the FDA are far too
complex to fully detail in this article. However, some significant
items to note are:
Importers will be responsible for compliance with this rule.
This will be a stand-alone system. (The FDA has stated that it
will continue to work with US Customs to create a unified system.)
of food which have not been registered will be either refused
entry or stored at a secure facility at the importer’s
The definitions of country of origin and port of entry are different
from the Customs definitions.
notices may be filed no earlier than 3 days before the anticipated
entry date of the shipment into the US and no later than noon
of the day before entry.
notice will be required for each “article,” which
appears to be equivalent to an SKU.
notices will require up to 13 elements of information including
Customs numbers, identification of foreign manufacturer, type
of food based on FDA 7 digit product codes, lot code country of
origin, identification of importer and carrier.
amendments of the notices as to quantity, port of entry, time
of entry will be permitted up to two hours before arrival. No
amendments will be allowed as to the type of goods.
these newly proposed rules and the new rules expected to arrive
in April represent a sea change in regulation for many food
businesses. The significance of these changes is compounded
by the very short fuse to implement them. Zackler & Associates
strongly recommends that you now begin examining your business
operations to determine how you might be affected by these
new rules. We are available to assist you in that examination
and in the establishment to new systems to assure seamless
compliance when the rules become effective.
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