October 3 2017 Charles Bell Programs Director Consumers Union Safe Harbor DSHEA grandfathered all dietary supplement ingredients marketed in the United States before October 15 1994 These are ID: 671164
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Slide1
FDA Workshop on Pre-1994 Dietary Supplement Ingredients
October 3, 2017
Charles Bell, Programs Director
Consumers UnionSlide2
“Safe Harbor”
“DSHEA grandfathered all dietary supplement ingredients marketed in the United States before October 15, 1994. These are
considered safe for continued consumer use
.”
(Trade Assn web site)
“Old” dietary ingredients (ODIs) marketed in the U.S. before October 15, 1994 are “grandfathered” in under DSHEA, are considered to be safe for continued consumer use, and can be sold without prior notification to FDA.” (Law firm web site, 2012)BUT this proposed Safe Harbor… could allow unsafe ingredients to continue to be sold.
Click to edit Master title styleSlide3
Published lists of dangerous supplements in 1995, 2004, 2008, 2010 and 2016
Unsafe supplements can remain on the market a long time
Inadequate safety system with rarely used procedures, and long delays in removing dangerous ingredients
Dietary Supplement HazardsSlide4
Aconite
Aristolochia
Bitter orange
Caffeine powder
Cesium
ChapparalColloidal silverColtsfootComfreyCountry Mallow/Sida CordofoliaEphedraGermanderGermanium
Graviola
Greater Celandine
Green Tea Extract Powder
Kava
Lobelia
Methylsynephrine
Organ/glandular extracts
Pennyroyal OilRed Yeast RiceSkullcapUsnic AcidYohimbe
Risky Ingredients that have been on CR’s ListsSlide5
Supplement-related Liver InjuriesSlide6
“Green tea extract and concentrated infusions of green tea have been implicated in many cases of clinically apparent acute liver injury, including instances of acute liver failure and death…”
Green Tea (National Library of Medicine)Slide7
Dietary Supplement
Alerts and Safety Information
Picamilon
in Dietary Supplements
Consumer Advisory: Dietary Supplements Containing Silver May Cause Permanent Discoloration of Skin and Mucous Membranes (
Argyria
) [ARCHIVED] September 1994
DMAA in Dietary Supplements
Letter to Health Professionals regarding safety concerns related to the use of botanical products containing aristolochic acid [ARCHIVED] April 4, 2001
DMBA in Dietary Supplements
FDA Advises Dietary Supplement Manufacturers to Remove Comfrey Products From the Market [ARCHIVED] July 6, 2001
BMPEA in Dietary Supplements
Letter to Health Care Professionals: FDA Consumer Advisory Regarding Dietary Supplements that Contain Silver [ARCHIVED] October 6, 2009
Pure Powdered Caffeine
Hepatic Toxicity Possibly Associated with Kava-Containing Products (CDC MMWR Report) November 29, 2002
Energy "Drinks" and Supplements: Investigations of Adverse Event Reports [ARCHIVED]
Consumer Advisory: Kava-Containing Dietary Supplements May be Associated With Severe Liver Injury [ARCHIVED] March 25, 2002
Concerns About Botanicals and Other Novel Ingredients in Conventional Foods [ARCHIVED]
Risk of Drug Interactions with St. John's
Wort
and
Indinavir
and other Drugs [ARCHIVED]
February 10, 2000FDA Advises Dietary Supplement Manufacturers to Remove Comfrey Products From the Market [ARCHIVED] July 6, 2001Adverse Events with Ephedra and Other Botanical Dietary Supplements [ARCHIVED] September 1994FDA Concerned About Botanical Products, Including Dietary Supplements, Containing Aristolochic Acid [ARCHIVED] April 11, 2001Source: www.FDA.gov Safety Alerts & Advisories
EPHEDRA (Removed, 2004)
FDA Has Removed Only 1 Unsafe Old Dietary IngredientSlide8
Over half (57%) of Americans believe that supplements have been tested to be safe by the manufacturer. 38% believe supplements have been tested for safety
by the FDA
.
Nearly half (46%) of Americans believe that federal law requires dietary supplements to be proven safe before they are marketed.
64% agree that supplements need to be better regulated for safety. Source: 2015 CR National SurveyConsumers Presume Supplements Will Be Safe Slide9
Source: “Dangerous Supplements Still At Large,”
Consumer Reports, May 2004
Consumers Presume Supplements Will Be Safe Slide10
Need process to “de-list” UNSAFE pre-1994 supplement ingredients, either through FDA action, voluntary agreement with industry, and/or changes in the law
Universal substantiation of safety for ALL supplement ingredients
Prioritize use of regulatory resources to remove unsafe ingredients, and require declaration of undeclared NDIs, with binding deadlines
Ensure transparency of information regarding safety and conditions of use, by avoiding excessive designation of submissions as trade secrets.
RecommendationsSlide11
Charles Bell, Programs Director
Consumers Union
(914) 378-2507
www.ConsumerReports.org
www.ConsumersUnion.orgcbell@consumer.orgContact Information