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Potential risk to our access to high dose supplements? – Issue

Current media stories about pending national legislation that could restrict access to dietary supplements in the United States brought back memories of when several individuals, who were also leaders of American Holistic Health Association (AHHA), were attending international meetings under the Codex Alimentarius that was forming guidelines for global standards for food and dietary supplements. Knowing that these “voluntary guidelines” were slated to be used by the World Trade Organization in settling trade disputes, what happened at Codex meetings became very personal.

Here is excerpt from a report from AHHA president, Suzan Walter, of the November 3-7, 2003 session of Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) in Bonn, Germany. “A decade of polarized debate quietly came to an end on November 3, 2003. A major decision impacting international trade of nutritional supplements was made to use upper safe limits as the maximum allowed levels for vitamin and mineral food supplements. It was decided that sound scientific research using proper risk assessment protocols will establish at what point a nutrient becomes toxic or harmful. To protect the consumer, vitamin and mineral food supplement products are to be restricted to stay below this upper safe limit. The alternative option would have set these maximum levels at a significantly lower level of 100% of the recommended daily amounts (RDA). Delegates who were against this option envisioned a future with supplement products restricted to very low levels of potency. We can breathe easier that this option was defeated.”

While Codex selected the method for establishing the “upper safe limits,” it did not define the actual maximum dose levels for vitamin and mineral supplements. The European Union standards are very restrictive. Are the current generous access standards in the U.S. at risk from some seemingly unrelated dietary supplement proposed legislation, the Dietary Supplement Listing Act of 2022?

Issue: Awareness of potential threat to your continued access to high dose vitamin and mineral supplements?

AHHA strives to maintain a neutral position on issues and views knowledge as power. For those interested in this month’s issue, below we provide you with a timeline of articles to create an awareness of a matter you may wish to keep in mind as you review upcoming media coverage related to dietary supplement legislation as it passes through committees and eventually reaches the floor for official vote.

Protect High Dose Supplements
Blackbaud Inc.
[Succinct overview of international situation]

Codex Alimentarius: Globalizing Food (7/9/05)
National Health Federation
[History of referenced Codex Alimentarius Committee on Nutrition and Foods for Special Dietary Uses]

Suzan Walter Codex Report November 2003
American Holistic Health Association
[Report with CCNDFDU status in 2003]

Responses to Questions about Codex and Dietary Supplements (3/21/18)
U.S. Food & Drug Administration
[U.S. government view of Codex and dietary supplements as of 2018]

Dietary Supplement Listing Act of 2022
117th Congress 2nd Session
[The proposed national legislation related to dietary supplement product registration, nicknamed the Durbin Bill “to improve transparency and the availability of information regarding dietary supplements by amending the Federal Food, Drug, and Cosmetic Act to require manufacturers of dietary supplements to list dietary supplements with the Food and Drug Administration.”]

Dietary Supplement Listing Act of 2022 Introduced; Industry Divided (4/27/22)
by Maggie Jaqua
Whole Foods
[Overview of supplement industry reaction to Durbin Bill]

Durbin Bill Signals End of High-Dose Supplements (5/5/22)
Alliance for Natural Health USA
[Explains concern that Durbin Bill could make it feasible to apply restrictive European Union limits that could eliminate access to high dose supplements]

S.4348 – FDASLA Act of 2022 (6/14/22)
117th Congress (2021-2022)
Congress.gov
[Bill 4348 in Senate Health, Education, Labor, and Pensions (HELP) Committee “to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes.” had addition of numerous amendments at 6/14/22 committee meeting –– including the addition of the Durbin Bill to be part of S.4348.]

Senate Committee Passes Bill with Mandatory Supplement Listing (6/16 /22)
Alliance for Natural Health USA
[“This week, the Senate HELP Committee voted to approve its FDA user fee bill with mandatory dietary supplement product listing attached.”]

To review past ISSUES, visit the Special Updates Archives.

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