"Why won't these Guidelines restrict U.S. consumers' access to vitamin and mineral supplements?
Some consumers mistakenly believe that with the adoption of the Guidelines on Vitamin and Mineral Food Supplements, the U.S. is required to automatically change its laws and regulations to comply with the international standard. Some have expressed concerns that the World Trade Organization (WTO) and its trade dispute settlement panels may place pressure on the U.S. to change its laws because of international trade agreements such as the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement), which references
Codex as the international organization for food safety standards.
We see no basis for these concerns. First, the DSHEA covers a much broader range of dietary supplements than the vitamin and mineral supplements that are the subject of the
Codex Guidelines. Moreover, for supplements covered by these Guidelines, we note the following:
* The SPS Agreement does not require a country to adopt any international standard. Rather, the SPS Agreement provides that members may base their Sanitary and Phytosanitary measures either on international standards, guidelines or recommendations, where they exist, or may establish measures that result in a higher level of protection if there is a scientific justification, or if a country determines it to be appropriate in accord with provisions of the SPS Agreement (SPS Agreement, Article 3(1) and (3)).
* WTO and WTO dispute panels do not have the power to change U.S. law. If a WTO decision in response to a dispute settlement panel is adverse to the U.S., only Congress and the Administration can decide whether to implement the panel recommendation, and, if so, how to implement it.
* For dietary supplements, it is unlikely that another country will accuse the U.S. of imposing a trade barrier for the importation of supplement products into the U.S. marketplace because the U.S. laws and regulations are generally broader in scope and less restrictive than the international standard.
* However, other countries with more restrictive laws and regulations for dietary supplement products than the U.S. may create trade barriers to the importation of products manufactured by the U.S. dietary supplement industry. Thus, the U.S. government's involvement in the setting of international standards can help minimize the potential of trade barriers to U.S products in international trade.
Further, there is no basis for the concern that the
Codex Guidelines on Vitamin and Mineral Food Supplements would require dietary supplements be sold as prescription drugs in the United States. First, there is nothing in the Guidelines that suggests that supplements be sold as drugs requiring a prescription. Second, U.S. regulatory agencies are bound by the laws established by Congress, not by
Codex standards. Third, because of our generally less restrictive standards, it is unlikely that the trade dispute would be brought against the U.S.
In summary, U.S. consumers' access to a broad array of dietary supplements under DSHEA would not be changed in any way by
Codex's adoption of guidelines on vitamin and mineral food supplements."
http://www.cfsan.fda...ms/dscodex.html
