New, OF HEALTH AND HUMAN SERVICES Pubiic Health Service

 

.er' 

Food and Drug Administration
a Coilege Park, MD 207?40-
AUG 2 5 2005

Mr .. Shalin Gala
Research Associate
Research Investigations Department
People for the Ethical Treatment of Animals
501 Front Street

. Norfolk, Virginia 23510

Dear Mr. Gala:

This is in response to your May 16, 2006, letter in which you ask about the
Food and Drug Administration?s (F the Agency?s) position on a number of speci?c
animal testing questions related to substantiation of health claims and/or product safety.

In a review of'health claims, both those meeting signi?cant scienti?c agreement (SSA) and
quali?ed health claims, the Agency ?rst determines that the submitted data and information
could support a relationship between the substance and the disease or health-related
condition, and then evaluates the individual reports ofhuman studies to determine whether
any Scienti?c conclusions can be drawn from each study. In addition to individual reports of
human studies, the agency also considers other types of data and information in its review,
such as meta?analyses, review articles, and animal and in vitro studies. These other types of
data and information may be useful to assist the agency in understanding the scientific issues
about the substance, the disease or health-related condition, or both, but cannot by
themselves support a health claim relationship.

For authorized health claims 21 343 states that ifthe agency ?determines
based on the totality ofthe publicly available evidence (including evidence ?om well-
designed studies conducted in a manner which is consistent with generally recognized
scienti?c procedures and principles), that there is signi?cant scienti?c agreement, among
experts quali?ed by scienti?c training and experience to evaluate such claims, that the claim
is supported by such evidence.? Animal studies may be used to generate hypotheses or to
explore a mechanism of action but cannot adequatelywsupport a relationship between the
substance and the disease by themselves. A company can substantiate their proposed health
claim(s) based on data generated from laboratory and/0r clinical studies that were conducted
solely on humans.

In your letter, you also asked whether the FDA requires food or beverage companies to
conduct laboratory experiments on animals to ensure that the companies? products are safe
for human consumption. Any food product (eg. juice products) offered for sale in interstate
commerce must be safe for human consumption. In order to adequately ensure that a
product is safe for human consumption, a company must carefully consider the nature of the
safety question(s) to be resolved. If'a manufacturer concludes that further information is
needed to support the safety of a given product, animal studies may be useful in cases where

 

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certain information cannot practically be collected ?'om other test sources. For example,
although not required by law, animal studies are often used to establish the safety of food
ingredients requiring premarket approval by FDA. -

In some cases, after considering available alternatives, a manufacturer may determine that
there are no better alternatives for well conducted animal studies to assure the safety of a
product or ingredient.

The review of proposed health claim(s) and product safety is based on an evaluation
of a body of supporting evidence for the claim(s), and not on speci?c types of studies. As
such, the Agency is-not aware of any circumstances that would result in the FDA requiring a
food or beverage company to conduct laboratory experiments on animals. There are no
different health claim and/or product safety testing regulations that apply to speci?c 
products, e. g. Gatorade. It is the responsibility of the manufacturer to provide complete and
convincing evidence to support their proposed health claim(s) or ensure their product?s
safety.

We hope that the above information has been useful.

   

Barbara 0.. Schneeman, Director

Office of'Nutritional Products, Labeling
and Dietary Supplements