Frequently Asked Questions – Codex
What is Codex's role in the regulation of dietary supplements?
The Codex Alimentarius Commission formed several committees to explore the development of guidelines governing vitamin and mineral supplements, food labeling and food additives. These guidelines are part of a series of guidelines being developed in connection with the World Trade Organization Agreement (also known as GATT). Every country that has ratified GATT (including the United States ) has formed an official delegation that it sends to these committees.
Would Codex change the availability of dietary supplements in the United States?
The primary concern in the United States about Codex is, of course, whether adoption of final Codex Supplement Guidelines by the Codex Commission threatens the freedom to access dietary supplements and information about supplements that are guaranteed in the United States by DSHEA, the Dietary Supplement Health and Education Act of 1994. Put another way, will individual countries that have ratified GATT, such as the United States, be required to conform their own laws and regulations governing vitamin and mineral supplements to the final Codex Supplement Guidelines?
The answer is no. The federal statute by which the United States ratified the WTO Agreement (the Uruguay Round Agreements Act or "URAA"), explicitly provides:
"No provision of any of the Uruguay Round Agreements, nor the application of any such provision to any person or circumstance, that is inconsistent with any law of the United States shall have effect." (19 U.S.C. §3512(a)(1)).
URAA further provides:
"Nothing in this Act shall be construed to amend or modify any law of the United States, including any law relating to the protection of human, animal or plant life or health." (19 U.S.C. §3512 (a)(2)(A)(i)).
Therefore, in the process of ratifying GATT, Congress took care to protect U.S. laws by these express provisions. The application of GATT, including international guidelines adopted in connection with that Agreement such as the Codex Supplement Guidelines, will not have any legal effect on U.S. federal statutes, including a public health statute such as DSHEA. This is so even if particular provisions in such guidelines differ from particular provisions of DSHEA.
In sum, no amendment, repeal or other change to DSHEA would be required, as a matter of U.S. law. Since the Codex Supplement Guidelines do not require any change to DSHEA, the guidelines will not have any practical impact on sales of dietary supplements in the United States, by either suppliers or retailers. DSHEA will continue to govern domestic sales.
This fact has even been recognized by the FDA in an "Information Paper" issued by the agency on September 8, 1997:
"The public concern that the proposed Codex Alimentarius Guidelines (Codex) may restrict the availability of dietary supplements in the United States or limit the amount and type of information that may legally be disseminated by manufacturers may arise from, in part, a misunderstanding of the requirements which the United States is obligated to abide by as a signatory to the Final Act of the Uruguay Round, which includes the includes the GATT and other agreements having bearing on these concerns. Nothing in the trade agreements or process will restrict either the sale of dietary supplements in the United States or the type of information that manufacturers may provide to consumers about their products."
What is the scope of the Codex focus on dietary supplements?
The commission has a committee developing guidelines on the composition and labeling of vitamin and mineral supplements. The guidelines are presently under consideration by the Codex Committee on Nutrition and Foods for Special Dietary Use (CNFSDU). At a November 2004 meeting, CNFSDU agreed to make recommendations on final guidelines for vitamin and mineral supplements (and thereafter, possibly, for other types of dietary supplements as well) to the full Codex Alimentarius Commission.
Will international harmonization directives in GATT, or in the FDA Modernization Act of 1997 or "FDAMA," somehow undermine DSHEA freedoms?
1. Harmonization Under the SPS Agreement
At this time, no definitive determination has been made as to which of the various international sub-agreements comprising GATT will be the international trade mechanism for application of any Codex Supplement Guidelines. One possibility is the Agreement on Application on Sanitary and Phytosanitary Measures (the "SPS Agreement"), which pertains in relevant part to measures intended to protect human or animal life or health from "risks arising from additives, contaminant, toxins or disease-causing organisms in foods." However, based on this language, it is quite debatable whether Codex guidelines governing dietary supplements, even though they might claim to be issued as a safety measure, could properly be deemed a "sanitary/phytosanitary" provision. Nonetheless, assuming that they could, Article 3 of the SPS Agreement, titled "Harmonization," must be examined.
This article does not define the term "harmonization." Rather, it makes a general statement: "To harmonize sanitary and phytosanitary measures on as wide a basis as possible, members shall base their sanitary or phytosanitary measures on international standards, guidelines or recommendations." This general statement is then qualified by two explicit exceptions:
"Members may introduce or maintain sanitary or phytosanitary measures which result in a higher level of sanitary or phytosanitary protection than would be achieved by measures based on relevant international standards, guidelines or recommendations, if there is a scientific justification, or as a consequence of the level of sanitary or phytosanitary protection a member determines to be appropriate [in accordance with certain risk assessment criteria provided in article 8 of the SPS agreement]. Notwithstanding the above, all measures which result in a level of sanitary or phytosanitary protection different from that which would be achieved by measures based on international standards, guidelines or recommendations shall not be inconsistent with any other provision of this Agreement. (SPS Agreement, Article 3, para. 3) (emphasis supplied)."
Thus, the SPS Agreement specifically permits different sanitary/phytosanitary measures in individual GATT-ratifying countries, not necessarily limited to such measures providing a higher level of protection, so long as they are not inconsistent with the SPS Agreement. DSHEA was enacted upon findings by the U.S. Congress that (a) dietary supplements are safe within a broad range of intake, (b) safety problems with supplements are relatively rare, and (c) DSHEA constitutes a rational federal framework for dietary supplements. These findings are not inconsistent with the SPS Agreement.
It follows that provisions of DSHEA differing from final Codex Supplement Guidelines will not contravene the harmonization article of the SPS Agreement.
2. Harmonization Under the TBT Agreement
The other potentially relevant trade mechanism for application of Codex Supplement Guidelines is the Agreement on Technical Barriers to Trade (the "TBT Agreement"), which is intended to promote member countries' use of standards based on work done by international bodies.
The Codex Commission can properly be considered an international standard-setting body under the TBT Agreement. When the commission adopts standards or guidelines that are not considered SPS measures, they may be standards promulgated under the TBT Agreement.
A TBT standard is defined in pertinent part as a "document approved by a recognized body that provides for common or repeated use, rules, guidelines or characteristics for products, with which compliance is not mandatory." (TBT Agreement, Annex 1, para. 2). Thus, by definition, TBT standards are not mandatory. In addition, central government bodies of TBT member countries are only required to use TBT standards "as a basis for the standards it develops." (TBT Agreement, Annex 3, para. F). Countries are not required to adopt the TBT standards themselves. Moreover, there is an exception to this "basis" provision: "where such international standards or relevant parts would be ineffective or inappropriate, for instances because of an insufficient level of protection or fundamental climatic or geographical factors or fundamental technological problems." (TBT Agreement, Article 2.4). By its terms, this exception is not restricted to its examples.
Accordingly, if final Codex Supplement Guidelines are deemed to be international standards applied under the TBT Agreement (rather than under the SPS Agreement), national laws such as DSHEA can, but do not have to, conform to them.
3. Harmonization Under FDAMA
Section 410(b) of FDAMA (21 U.S.C. 383(b))requires FDA in pertinent part to:
(1) support the Office of the United States Trade Representative...in meetings with representatives of other countries to discuss methods and approaches to reduce the burden of regulation and harmonize regulatory requirements if [FDA] determines that such harmonization continues consumer protection consistent with the purposes of this Act...
(2) regularly participate in meetings with representatives of other foreign governments to discuss and reach agreement on methods and approaches to harmonize regulatory requirements.
Neither of these provisions explicitly defines "harmonization," or explicitly mandates that FDA harmonize its regulatory requirements to those of other countries.
In any event, Section 410(b)(5) of FDAMA (21 U.S.C. 383(b)(5))contains the following explicit exemption for dietary supplements:
Paragraphs (1) through (4) shall not apply with respect to products defined in Section 201(ff). (emphasis supplied)
This exemption was added during FDAMA's legislative process through efforts of the Natural Products Association. Therefore, whatever harmonization with foreign regulatory requirements may be required by this Act for other FDA-regulated products, dietary supplements are explicitly exempted. DSHEA's requirements continue to control.
Will final Codex supplement guidelines differing from DSHEA, if adopted by other countries, have an effect on the sale of vitamin and mineral supplements by U.S. companies in those countries?
Other countries that have ratified GATT have the option of adopting final Codex Supplement Guidelines. U.S. suppliers exporting vitamin and mineral supplements for sale in countries which decide to adopt the Codex Supplement Guidelines will have to comply with the Codex Guidelines for products involved in such sales. This could conceivably mean, for example, that structure/function claims may not be able to be made for supplements sold in those countries. However, NPA and other interested groups are working within the relevant Codex Committees to assure that final Codex Supplement Guidelines are consistent with DSHEA.
Does the United States have any say about what is passed by Codex or the EU?
The U.S. does not have any official say about what is passed in the European Union, though certain organizations such as the TABD try to help bridge differences in applicable law.
The U.S. Codex Office, located in the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA), is the U.S. contact point for the Codex Commission and its activities. The U.S. Codex Office puts together delegations to each Codex committee meeting, arranges public meetings in Washington D.C. to gather comments from interested parties and publishes all relevant proceedings. The website for the U.S. Codex Office—with links to all relevant developments—is www.fsis.usda.gov/Regulations_&_Policies/Codex_Alimentarius/index.asp.
Is there a need for a congressional hearing on Codex?
Given the fact that there is no threat to DSHEA posed by Codex, as explained above, there does not appear to be a need for a congressional hearing.
Is the Natural Products Association violating any conflict of interest bylaw by its activities at Codex?
No. Section 2.1 (f) of NPA's bylaws provides that one of the association's purposes is "to encourage laws and regulations consistent with the Association's goals, and to protect the industry from laws, regulations and other actions adverse to its best interest." As explained above, NPA's efforts to assure that DSHEA's freedoms are adopted internationally through Codex are certainly consistent with NPA's goals, and are not adverse to the interests of the association or the dietary supplement industry.
The notion that has surfaced that NPA is somehow engaged in a conspiracy with pharmaceutical companies by supporting Codex is entirely unfounded. As noted above, NPA's support of Codex's adoption of dietary supplement guidelines that are consistent with DSHEA will promote, not undermine, the sale of supplements internationally.
Is there anything that would prevent the United States from adopting the Codex guidelines if it chose to do so?
Although no law would prevent the United States from accepting Codex guidelines on vitamin and mineral supplements, according to a U.S. Department of Agriculture (USDA) official, the United States has never changed its laws or regulations to conform to any standards or guidelines adopted by Codex. He noted further that the United States does not, as a matter of practice, officially accept, accept in part, accept free distribution, or not accept standards or guidelines adopted by the Codex Commission. Therefore, it doesn't appear that any changes to U.S. law or regulations would likely occur as a result of any adoption by the Commission of the vitamin and mineral food supplement guidelines. The FDA has affirmed this point with respect to vitamins and minerals, noting that the United States would not adopt any guidelines that are in conflict with (or would require any changes to) U.S. laws or regulations.
Who would decide whether to accept any Codex guidelines on vitamin and mineral food supplements if they were adopted by the Codex Commission?
Our research indicates that the FDA would determine whether or not to accept any guidelines on vitamin and mineral food supplements adopted by the Codex Commission.
If the United States decided to accept Codex guidelines, how would they be adopted?
Because the United States has not adopted Codex guidelines, there is no procedural precedent. It is likely that if the FDA were to consider accepting guidelines adopted by the commission, there would be a notice and comment period in which interested parties could submit comments to the FDA on whether the move was advisable. There is a provision in the Code of Federal Regulations (21 CFR 130.6) that provides specific procedures for the FDA to accept or not food standards adopted by the commission. Again, however, this provision has not been used.
What is the Natural Products Association doing about these issues?
NPA's policy regarding the use and sale of dietary supplements in the international arena has been to lobby for adoption of DSHEA-style laws or regulations. NPA has been and will continue to be very active with the Codex Commission by attending meetings and filing comments on that press for Codex's adoption of DSHEA and other provisions of U.S. law, such as the ability to use structure/function and health claims.
If NPA and others are successful in these efforts, there will be no concern about selling supplements in foreign countries under more restrictive rules. The principles embodied in DSHEA will apply internationally.
What can Natural Products Association members do to support health freedoms in regard to Codex?
Continue to support NPA's active involvement in Codex activities and contact overseas customers to urge them to advocate adoption of DSHEA's provisions by their own governments and Codex delegations.