The “Accepted Dietary Ingredient List” in the McCain bill is an especially troubling provision since such a code provision moves us away from our Common Law Right to access the foods we choose to a Civil Law (Codex Alimentarius) regulation of what we may choose. Under the Common Law what is not explicitly forbidden is allowed; under the Code, whatever is not explicitly permitted is forbidden. This “lawyer’s distinction” is of the greatest significance in preserving our Liberty. This provision could outlaw thousands of herbs, minerals and nutrients, just as similar European provisions are limiting dietary ingredient choice under the EU’s implementation of Codex.

At a press conference held earlier today, Sen. John McCain (R-Ariz.) announced that he would be introducing legislation that would amend the Dietary Supplement Health and Education Act (DSHEA) to give the U.S. Food and Drug Administration (FDA) additional powers over retailers and suppliers in the dietary supplements industry. The Natural Products Association is reviewing McCain’s bill, which is cosponsored by Sen. Byron Dorgan (D-N.D.), and offers this initial analysis regarding the impact of the legislation on the industry.

NPA will work aggressively to address this threat to the industry. The association will continue to keep its members informed and let them know how they can help protect their businesses.

Brief description of the provisions of the Dietary Supplement Safety Act of 2010

New Requirements from Suppliers to Retailers

Suppliers and retailers regardless of size all along the chain of commerce are required to “obtain adequate written evidence” from the seller that the product is registered as required. That evidence must be retained in a file available for inspection.

Adverse Event Reporting (AER)

Requires reporting of all adverse events, not just serious adverse events. In addition, a compilation of non-serious AERs must be submitted annually, and records must be maintained for three years.

“Accepted Dietary Ingredients” List

Mandates creation by the Secretary of a list of “Accepted Dietary Ingredients” to replace the current “in commerce pre-DSHEA” test.

New Dietary Ingredients (NDI)

NDIs are considered adulterated unless there is a history of use or evidence of its safety. Registrants shall maintain a “scientifically reasonable substantiation file” available for inspection by the Secretary of Health and Human Services. Registration required 75 days prior to market.

Recall Authority

Provides immediate recall authority to the Secretary upon determination that a supplement “would cause serious, adverse health consequences or death, or is adulterated or misbranded.” Companies subject to a recall have the right to challenge the order in an “informal hearing” within 10 days. At their own expense, retailers must notify customers of such recalls.

Registration of Dietary Supplement Facilities

Dietary supplement facilities shall register with the Secretary (required information includes name, address of all facilities, trade names, list of supplements, their ingredients, and labels). Registration is annual.

Read the complete bill here:
http://www.npainfo.org/clientuploads/regulatoryLegislative/2010%20Dietary%20Supplement%20Safety%20Bill.pdf

This entry also posted at: http://www.campaignforliberty.com/blog.php?view=32204
And: http://vitaminlawyerhealthfreedom.blogspot.com/2010/02/mccain-bill-poses-threat-to-dshea-and.html

“…there are a host of problems in the bill serious enough to make it a completely irreparable and untenable piece of legislation. These include:

(1) The creation of completely outrageous European Food Supplements Directive (EFSD)/Health Canada-esque facility registration requirements for all brands, products and ingredients, despite the fact that food facilities are already required to be registered;

(2) The effective removal of the “generally recognized as safe” (GRAS) status for most major dietary supplement/herbal ingredients, thereby deeming most supplements as “adulterated” unless they are included on the FDA’s “Accepted Dietary Ingredients” list;

(3) The creation and maintenance of voluminous safety dossiers on every dietary supplement and ingredient;

(4) The requirement that “all adverse events” (not just serious adverse events) relating to supplements be reported, including non-serious, trivial and unsubstantiated reports; and

(5) The codification of arbitrary and capricious cease-and-desist and recall authority based merely on the FDA’s “reasonable probability” that an item is adulterated or misbranded (this action can be taken regardless of whether the manufacturer is properly challenging the order).

This bill’s proposed establishment of an “approved list of ingredients” (much like EFSD’s approved lists of supplement ingredients and ingredient forms) is something to which the U.S. government (specifically the U.S. Codex delegation) has been adamantly opposed. So why would that same U.S. government endeavor to create “lists” – within its own borders – that it sees fit to battle against internationally?

In addition, the proposed provision that would require “all” adverse events to be reported would bog the AER system down with hundreds, if not thousands, of trivial and product-unrelated reports. This would serve to bury reports noting potential areas of commonality (signal events) in a garbage heap of useless information…”