Greater Seattle's natural, organic grocery store - INTERNATIONAL … · 2017-09-11 · of dietary...
3
www.nnfa.org NNFA Today, Volume 18, No. 11 / November/December 2004 10 The EU Directive applies only to products sold in the European Union. It does not apply to retailers in the United States INTERNATIONAL NEWS Editor’ Note: To help its members better understand the impact of international decisions made about dietary supplements and other nat- ural products, NNFA has excerpted the following from a more com- prehensive document, which can be found online at www.nnfa.org/ services/government/international/EUdir_Codex_QA.htm. NNFA’s positions on international issues can also be accessed online at www.nnfa.org/services/government/international Q I’ve heard that a law in Europe called the “EU Directive on food supplements” will force retailers in the United States to stop selling thousands of dietary supplements. Is this true? A No. European Directive 2002/46/EC relating to food supple- ments establishes harmonized rules for the labeling of food sup- plements and introduces specific rules on vitamins and minerals in food supplements. The directive applies only to products sold in the European Union. It does not apply to retailers in the United States. QDoes the EU Directive have any impact on U.S. manufacturers and distributors of dietary supplements? A While the directive applies only to member countries of the European Union, U.S. manufacturers and others who export dietary supplements with ingredients not contained on lists in the directive will no longer be able to sell those products in the European Union as of August 1, 2005. QWhat does the directive do specifically, and how will it affect the dietary supplement market in Europe? A The EU Directive specifies which food supplements may be sold in Europe. Listed in Annexes I and II of the directive are all vita- mins and minerals that may be sold as food supplements in the European Union and vitamin and mineral substances that may be used in the manufacture of food supplements. (Visit www.nnfa.org/services/government/ international/EUlists.htm to view the annexes.) As of August 1, 2005, manufacturers, distributors and retailers of food supplements in Europe will not be allowed to sell food supplements containing vitamins and minerals and forms other than those listed in Annexes I and II. Q I read the EU Directive is part of a larger regulation known as Codex. Is that true? A No. The Codex Alimentarius Commission (Codex) is an organ- ization completely separate from the European Union and the European Directive. Codex is a body responsible for implementation of the Joint Food and Agriculture Organization/World Health Organi- zation Food Standards Program, which was established to develop international food standards in the interests of enhanc- ing consumer protection and ensuring fair international trade in food products. The European Food Supplements Directive is a product of the European Union—and not of Codex. However, many are under the mistaken impression that there is a link because recent Codex considerations have also tended to favor making only a restricted group of supplements available to consumers. QWhat is Codex’s role in the regulation of dietary supplements? A Codex 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). International Natural Products Regulations Q&A: What Affect do They Really Have on the U.S.? by Sidley Austin Brown & Wood LLP, NNFA General Counsel
Transcript of Greater Seattle's natural, organic grocery store - INTERNATIONAL … · 2017-09-11 · of dietary...
www.nnfa.org NNFA Today, Volume 18, No. 11 / November/December 200410
The EU Directive
applies only to
products sold in
the European
Union. It does
not apply to
retailers in the
United States
INTERNATIONAL NEWS
Editor’ Note: To help its members better understand the impact ofinternational decisions made about dietary supplements and other nat-ural products, NNFA has excerpted the following from a more com-prehensive document, which can be found online at www.nnfa.org/services/government/international/EUdir_Codex_QA.htm. NNFA’spositions on international issues can also be accessed online atwww.nnfa.org/services/government/international
Q I’ve heard that a law in Europe called the “EU Directive onfood supplements” will force retailers in the United States tostop selling thousands of dietary supplements. Is this true?
A No. European Directive 2002/46/EC relating to food supple-ments establishes harmonized rules for the labeling of food sup-plements and introduces specific rules on vitamins and mineralsin food supplements. The directive applies only to products soldin the European Union. It does not apply to retailers in theUnited States.
Q Does the EU Directive have any impact on U.S. manufacturersand distributors of dietary supplements?
A While the directive applies only to member countries of theEuropean Union, U.S. manufacturers and others who exportdietary supplements with ingredients not contained on lists inthe directive will no longer be able to sell those products in theEuropean Union as of August 1, 2005.
Q What does the directive do specifically, and how will it affectthe dietary supplement market in Europe?
A The EU Directive specifies which food supplements may be soldin Europe. Listed in Annexes I and II of the directive are all vita-mins and minerals that may be sold as food supplements in the
European Union and vitamin and mineral substances that maybe used in the manufacture of food supplements. (Visitwww.nnfa.org/services/government/ international/EUlists.htm toview the annexes.)
As of August 1, 2005, manufacturers, distributors andretailers of food supplements in Europe will not be allowed to sellfood supplements containing vitamins and minerals and formsother than those listed in Annexes I and II.
Q I read the EU Directive is part of a larger regulation knownas Codex. Is that true?
A No. The Codex Alimentarius Commission (Codex) is an organ-ization completely separate from the European Union and theEuropean Directive.
Codex is a body responsible for implementation of theJoint Food and Agriculture Organization/World Health Organi-zation Food Standards Program, which was established todevelop international food standards in the interests of enhanc-ing consumer protection and ensuring fair international trade infood products.
The European Food Supplements Directive is a product ofthe European Union—and not of Codex. However, many areunder the mistaken impression that there is a link because recentCodex considerations have also tended to favor making only arestricted group of supplements available to consumers.
Q What is Codex’s role in the regulation of dietary supplements?A Codex formed several committees to explore the development
of guidelines governing vitamin and mineral supplements, food labeling and food additives. These guidelines are part of aseries of guidelines being developed in connection with theWorld Trade Organization Agreement (also known as GATT).
International Natural Products Regulations Q&A:
What Affect do They Really Have on the U.S.?
by Sidley Austin Brown & Wood LLP, NNFA General Counsel
NNFA Today, Volume 18, No. 11 / November/December 2004 www.nnfa.org 11
According to a
USDA Codex
official, the
United States
has never
changed its
laws to
conform to
any standards
or guidelines
adopted by
Codex
Every country that has ratified GATT (including the UnitedStates) has formed an official delegation that it sends to thesecommittees.
Guidelines on the composition and labeling of vitamin andmineral supplements are presently under consideration by theCodex Committee on Nutrition and Foods for Special DietaryUse (CNFSDU). At a November 2004 meeting, CNFSDUagreed to make recommendations on final guidelines for vitaminand mineral supplements (and thereafter, possibly, for other typesof dietary supplements as well) to the full Codex Commission.The commission will meet in July 2005 to discuss adopting the guidelines.
Q Will final Codex supplement guidelines differing fromDSHEA, if adopted by other countries, have an effect on thesale of vitamin and mineral supplements by U.S. companiesin those countries?
A Other countries that have ratified GATT have the option ofadopting final Codex Supplement Guidelines. U.S. suppliersexporting vitamin and mineral supplements for sale in countriesthat decide to adopt the Codex Supplement Guidelines will haveto comply with the guidelines for products involved in such sales.This could conceivably mean, for example, that structure/func-tion claims may not be able to be made for supplements sold inthose countries. However, NNFA and other interested groups areworking within relevant Codex committees to assure that finalCodex Supplement Guidelines are consistent with DSHEA.
Q Does the United States have any say about what is passed byCodex or the EU?
A The United States does not have official say about what is passedin the European Union. The U.S. Codex Office puts togetherdelegations to each Codex committee meeting, arranges publicmeetings in Washington D.C. to gather comments from inter-ested parties and publishes all relevant proceedings. The Web sitefor the U.S. Codex Office is www.fsis.usda.gov/Regulations_&_Policies/Codex_Alimentarius/ index.asp
Q Is there anything that would prevent the United States fromadopting the Codex guidelines if it chose to do so?
A No law would prevent the United States from accepting Codexguidelines on vitamin and mineral supplements. However,according to a U.S. Department of Agriculture Codex official,the United States has never changed its laws or regulations toconform to any standards or guidelines adopted by Codex. Henoted further that the United States does not, as a matter of prac-tice, officially accept, accept in part, accept free distribution, oraccept standards or guidelines adopted by the Codex Commis-sion. Therefore, it doesn’t appear that any changes to U.S. law orregulations would likely occur as a result of any adoption by theCommission of the vitamin and mineral food supplement guide-lines. The Food and Drug Administration has affirmed this pointwith respect to vitamins and minerals, noting that the UnitedStates would not adopt any guidelines that are in conflict with(or would require any changes to) U.S. laws or regulations.
Q Who would decide whether to accept any Codex guidelineson vitamin and mineral food supplements if they wereadopted by the Codex Commission?
A Our research indicates that FDA would determine whether ornot to accept any guidelines on vitamin and mineral food sup-plements adopted by the Codex Commission.
Q If the United States decided to accept Codex guidelines, howwould they be adopted?
A Because the United States has not adopted Codex guidelines,there is no procedural precedent. It is likely that if FDA were toconsider accepting guidelines adopted by the commission, therewould be a notice and comment period in which interested parties could submit comments to FDA on whether the movewas advisable. There is a provision in the Code of Federal
INTERNATIONAL NEWS
(Continued on page 12)
www.nnfa.org NNFA Today, Volume 18, No. 11 / November/December 200412
Because you belong to NNFA, you’re entitled to save up to 32% on select FedEx Express® and FedEx Ground®
shipments. It’s the FedEx Association Advantage®— another great advantage for members of NNFA. Simply call 800.966.6632, ext. 236.
Your NNFA Member Discounts
Up to 32% off Select FedEx Express Shipments
Up to 18% off Select FedEx Express International Shipments
Up to 21% off Select FedEx Ground Shipments
Up to 10% off Select FedEx Home Delivery® Shipments
Discounts are off published rates and cannot be combined with other offers or discounts. Discounts are exclusive of any FedEx surcharges, premiums,or special handling fees and are not available to package consolidators. Eligibility for discounts subject to FedEx credit approval. See the terms andconditions in the FedEx Service Guide for more details. Program may be discontinued at any time, and rates are subject to change. Varying discountsapply per service. FedEx First Overnight®, FedEx SameDay®, FedEx® International Next Flight, FedEx International First®, FedEx International PriorityDirectDistribution®, FedEx® 10kg Box, FedEx® 25kg Box, FedEx International Priority Plus®, and FedEx International MailServiceSM not included. Eligibleservices subject to change. © 2004 FedEx. All rights reserved.
NNFA delivers again:up to 32% off select FedEx®shipping.
Regulations (21 CFR 130.6) that provides specific procedures forFDA to accept or not food standards adopted by the commission.Again, however, this provision has not been used.
What is NNFA doing about these issues?A NNFA’s policy regarding the use and sale of dietary supplements
in the international arena has been to lobby for adoption ofDSHEA-style laws or regulations. NNFA has been and will con-tinue to be very active with the Codex Commission by attend-ing meetings and filing comments on that press for Codex’sadoption of DSHEA and other provisions of U.S. law, such as
the ability to use structure/function and health claims.If NNFA and others are successful in these efforts, there
will be no concern about selling supplements in foreign countriesunder more restrictive rules. The principles embodied inDSHEA will apply internationally.
Q What can NNFA members do to support health freedoms inregard to Codex?
A Continue to support NNFA’s active involvement in Codexactivities, and contact overseas customers to urge them to advo-cate adoption of DSHEA’s provisions by their own governmentsand Codex delegations. ❦
International Natural Products Regulations Q&A:
(Continued from page 11)
INTERNATIONAL NEWS
