October 23, 1997
Dr. Alan Rulis
U.S. Food and Drug Administration (HFS-200)
Office of Pre-Market Approval
200 C Street, S.W.
Washington, D.C. 20204
Re: Comments on matters arising from the 22nd session of the Codex Alimentarius
Commission as related to food additives and contaminants
The Center for Science in the Public Interest (CSPI) submits these comments on the Codex
General Standard for Food Additives: Proposed Draft Schedules of Food Additives (Antioxidants,
Preservatives, Stabilizers, Thickeners and Sweeteners) Specifically Permitted in Foods. We urge
the Food and Drug Administration (FDA) to strenuously oppose the adoption of those portions of
the General Standard that pertain to additives, or uses of additives, that have not been approved
by the FDA. By failing to take such action, the FDA would be increasing the possibility that
foreign nations will challenge the agency's current restrictions on food additives as an illegal trade
As the FDA knows, Codex standards now carry legal significance within the U.S.
The Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) encourages
nations to base domestic regulatory standards on international standards developed by the Codex
Alimentarius. Domestic regulatory requirements that are based on Codex standards are presumed
to be consistent with the SPS Agreement, and those that differ from Codex standards may be
challenged as trade barriers. Therefore, by acquiescing to the inclusion of additives in the Codex
General Standard that are not approved for use in the U.S., the agency would be supporting an
international standard that could be used by other nations to claim that the FDA's current
regulatory requirements are illegal trade barriers. In essence, by failing to object now, the FDA is
facilitating a challenge to the agency's regulations brought by a foreign country before a dispute
resolution panel of the World Trade Organization (WTO).
If another nation succeeds in a complaint brought before the WTO, the FDA -- and American
consumers -- may be forced to accept imports of foods containing the unapproved additive. In
theory, while the U.S. could ignore the WTO decision, it would have to pay reparations to the
complaining country. As a practical matter, it is unlikely that the Administration and the Congress
would resort to ignoring a WTO decision except in extreme cases. In most cases, the FDA would
likely be instructed to simply accept the importation of foods containing the unapproved additive.
Even if FDA later went through notice-and-comment rulemaking in such situations to permit the
use of the additive in the U.S., such action would merely constitute a post hoc justification for a
decision that had already been preordained. As such, any rulemaking conducted by the agency
would not represent a genuine opportunity for notice and comment as required by law and would
violate both the Federal Food, Drug and Cosmetic Act (FD&C) and the Administrative Procedure
The FDA must not set in motion a series of events that may lead to the bypassing of these
statutory requirements. Instead, the FDA must object strenuously and refuse to agree to the
inclusion in the Codex General Standard of any additives not approved in the U.S. For example:
- The FDA must not agree to the inclusion of cyclamates in the General Standard. Cyclamates
have been banned in the U.S. since 1970, but the Codex General Standard would allow its use
in several types of food. The FDA banned cyclamate after animal studies linked the artificial
sweetener to birth defects, the impairment of the function of testes, and the enhancement of the
carcinogenic effect of cancer-causing chemicals. Nonetheless, the Codex General Standard
would allow the use of cyclamates in carbonated water-based flavored drinks, which could
result in the consumption of large amounts of a food additive that the FDA has previously
found to be unsafe.
Similarly, the FDA must oppose the adoption of portions of the Codex General Standard that
permit the use of additives at levels or in specific foods that have not been approved by the
agency. The FDA has the statutory responsibility to ensure that food additives are safe by
prescribing limitations on the levels of use, by restricting the types of foods in which the additive
can be used, and by limiting the additive's purpose for which it may be used.
- The FDA must also object to the inclusion of sucralose in the Codex General Standard. Codex
would permit the use of sucralose, another artificial sweetener, in carbonated water-based
flavored drinks. The FDA has not approved the use of this additive, and the addition of this
unapproved substance to foods as frequently consumed as soft drinks would raise serious
public health concerns.
Nonetheless, a number of provisions in the Codex General Standard allow for the use of additives
in specific foods and in quantities that are not permitted by the FDA in the U.S. For example:
- The FDA permits acesulfame-K to be used in the U.S. only in yogurt, baked goods,
confections, and other select items, but the General Standard would allow acesulfame-K also
to be used in canned vegetables, infant formula, and foods for young children.
In sum, the FDA must reverse the position that it has traditionally taken at Codex meetings. In
light of the new legal effect of Codex standards, the agency must not agree to portions of the
General Standard on Food Additives that pertain to substances that are banned or not approved
for specific uses, or at specific levels, in the U.S. If the agency acquiesces to such portions of the
Codex General Standard, it would be failing to oppose an international rule that could be used by
other nations to claim that the FDA's current regulatory requirements pose illegal trade barriers.
In brief, the FDA will be facilitating a trade challenge before the WTO that could very well lead to
the invalidation of the agency's own regulations that were issued in accordance with its statutory
mandate to protect the health of American consumers.
- The Codex General Standard proposes to allow the use of aspartame in infant formula and
weaning foods. Such uses in the U.S. would violate FDA regulations.
For the foregoing reasons, we urge the FDA to oppose and, if necessary, refuse to accept portions
of the Codex General Standard on food additives that are inconsistent with its current regulatory
Director of Legal Affairs