The Truth Must Be Told About Dietary Supplement Regulation, Says the Council for Responsible Nutrition

Apr 11, 2001, 01:00 ET from Council for Responsible Nutrition

    WASHINGTON, April 11 /PRNewswire/ -- "A lot of nonsense is being spread
 about dietary supplements and how they are regulated.  These irresponsible and
 false statements mislead and confuse consumers and these tactics must stop
 immediately," said John Cordaro, President and CEO of the Council for
 Responsible Nutrition.  "False statements seriously damage consumer confidence
 in a wide range of useful and beneficial products and are especially critical
 when the statements are linked to concerns about serious public health issues
 such as BSE."
     For the past decade the U.S. Department of Agriculture (USDA) and the Food
 and Drug Administration (FDA) have been diligently enforcing import
 restrictions to keep BSE (bovine spongiform encephalopathy, also known as mad
 cow disease) out of the U.S.  These restrictions apply to ingredients used in
 dietary supplements, as well as to ingredients used in drugs or in
 conventional foods.  Some media articles have falsely claimed that dietary
 supplements are not covered by government actions intended to protect against
 BSE.  Bovine-derived ingredients used in dietary supplements include organ
 tissues such as liver and highly processed ingredients such as chondroitin or
 gelatin.  Many of these ingredients are derived entirely from U.S. cattle and
 are thus considered free of BSE risk.  Imports are permitted only in
 accordance with current government policies intended to avoid import of bovine
 ingredients from countries with BSE.
     At a February meeting with representatives of the dietary supplement
 industry, FDA official Dr. Robert Moore stated:  "FDA recognizes that the BSE
 problem relates to all foods, including conventional foods as well as dietary
 supplements."  He said there is no more risk from dietary supplements than
 from conventional foods containing the same ingredients.  All bovine
 ingredients are covered by the same regulations and import restrictions.
     In media coverage, it is often falsely claimed that dietary supplements
 are "unregulated" since passage of the Dietary Supplement Health and Education
 Act in 1994.  In fact, the 1994 law reaffirmed that dietary supplements are
 regulated like foods.  They have been regulated as a category of foods since
 the current Food, Drug and Cosmetic Act was enacted in 1938.  They are not
 drugs and have never been regulated as drugs.
     Like foods, dietary supplements are required to be safe.  There is a
 procedure requiring notification of FDA before new ingredients are introduced
 into dietary supplements, and the agency has disapproved numerous ingredients
 on safety grounds. FDA has authority to remove products from the market that
 are unsafe.  In recent years, FDA has in fact taken action against a number of
 dietary supplements.
     Like foods, dietary supplements are prevented from using bovine-derived
 ingredients from BSE countries.  All U.S. beef is considered safe for use in
 this country in any product, from conventional foods to dietary supplements to
 pharmaceuticals.  Beef and bovine-derived ingredients can be imported only if
 a company has a USDA import permit.  Such permits require a certificate of
 veterinary health from the country of origin, and imports are permitted only
 from countries where BSE is not a problem.  FDA has issued import alerts,
 which apply these same requirements to conventional foods, dietary
 supplements, and drugs.  FDA has a separate guidance document issued in 1997
 that applies specifically to gelatin, a bovine-derived ingredient used to make
 capsules and also used as an ingredient in many foods and drugs.
     Like foods, dietary supplements are required to provide full information
 to consumers through product labeling.  This includes information such as
 nutrition labeling and ingredient labeling.  The extensive labeling
 regulations are codified in Title 21 of the Code of Federal Regulations.  The
 law requires that all labeling for dietary supplements be truthful and not
 misleading, and FDA has authority to take action against any false statements
 made in labeling.  DSHEA imposed some additional requirements on dietary
 supplements, requiring companies to notify FDA when claims are made about
 beneficial effects on the structure or function of the body
 ("structure/function claims").  Marketers of conventional foods are not
 required to notify FDA when structure/function claims are made.
     Like foods, dietary supplements are required to be manufactured in
 accordance with Good Manufacturing Practices (GMPs), and plants are inspected
 by FDA to determine whether such practices are being followed.  Regulations
 describing food GMPs are set out in Title 21, Code of Federal Regulations,
 Part 110.  DSHEA authorized FDA to establish a set of GMPs specifically
 applying to dietary supplements.  The industry supports such GMPs and has
 supported FDA development of a new regulation, which is moving through the
 regulatory process.
     "Consumers are being bamboozled by some media and some health
 professionals who have an axe to grind against dietary supplements and who do
 not have a good understanding of legal and regulatory issues," said Annette
 Dickinson, Ph.D., CRN's Vice President for Scientific and Regulatory Affairs.
 "Irresponsible statements falsely charging that dietary supplements are
 unregulated are creating unnecessary concern among consumers and are grossly
 unfair to the industry.  This is especially outrageous when it relates to a
 serious issue such as BSE.  In fact, the industry is complying with U.S.
 import policies and is working with government agencies to ensure that
 consumers continue to be fully protected."
 
 

SOURCE Council for Responsible Nutrition
    WASHINGTON, April 11 /PRNewswire/ -- "A lot of nonsense is being spread
 about dietary supplements and how they are regulated.  These irresponsible and
 false statements mislead and confuse consumers and these tactics must stop
 immediately," said John Cordaro, President and CEO of the Council for
 Responsible Nutrition.  "False statements seriously damage consumer confidence
 in a wide range of useful and beneficial products and are especially critical
 when the statements are linked to concerns about serious public health issues
 such as BSE."
     For the past decade the U.S. Department of Agriculture (USDA) and the Food
 and Drug Administration (FDA) have been diligently enforcing import
 restrictions to keep BSE (bovine spongiform encephalopathy, also known as mad
 cow disease) out of the U.S.  These restrictions apply to ingredients used in
 dietary supplements, as well as to ingredients used in drugs or in
 conventional foods.  Some media articles have falsely claimed that dietary
 supplements are not covered by government actions intended to protect against
 BSE.  Bovine-derived ingredients used in dietary supplements include organ
 tissues such as liver and highly processed ingredients such as chondroitin or
 gelatin.  Many of these ingredients are derived entirely from U.S. cattle and
 are thus considered free of BSE risk.  Imports are permitted only in
 accordance with current government policies intended to avoid import of bovine
 ingredients from countries with BSE.
     At a February meeting with representatives of the dietary supplement
 industry, FDA official Dr. Robert Moore stated:  "FDA recognizes that the BSE
 problem relates to all foods, including conventional foods as well as dietary
 supplements."  He said there is no more risk from dietary supplements than
 from conventional foods containing the same ingredients.  All bovine
 ingredients are covered by the same regulations and import restrictions.
     In media coverage, it is often falsely claimed that dietary supplements
 are "unregulated" since passage of the Dietary Supplement Health and Education
 Act in 1994.  In fact, the 1994 law reaffirmed that dietary supplements are
 regulated like foods.  They have been regulated as a category of foods since
 the current Food, Drug and Cosmetic Act was enacted in 1938.  They are not
 drugs and have never been regulated as drugs.
     Like foods, dietary supplements are required to be safe.  There is a
 procedure requiring notification of FDA before new ingredients are introduced
 into dietary supplements, and the agency has disapproved numerous ingredients
 on safety grounds. FDA has authority to remove products from the market that
 are unsafe.  In recent years, FDA has in fact taken action against a number of
 dietary supplements.
     Like foods, dietary supplements are prevented from using bovine-derived
 ingredients from BSE countries.  All U.S. beef is considered safe for use in
 this country in any product, from conventional foods to dietary supplements to
 pharmaceuticals.  Beef and bovine-derived ingredients can be imported only if
 a company has a USDA import permit.  Such permits require a certificate of
 veterinary health from the country of origin, and imports are permitted only
 from countries where BSE is not a problem.  FDA has issued import alerts,
 which apply these same requirements to conventional foods, dietary
 supplements, and drugs.  FDA has a separate guidance document issued in 1997
 that applies specifically to gelatin, a bovine-derived ingredient used to make
 capsules and also used as an ingredient in many foods and drugs.
     Like foods, dietary supplements are required to provide full information
 to consumers through product labeling.  This includes information such as
 nutrition labeling and ingredient labeling.  The extensive labeling
 regulations are codified in Title 21 of the Code of Federal Regulations.  The
 law requires that all labeling for dietary supplements be truthful and not
 misleading, and FDA has authority to take action against any false statements
 made in labeling.  DSHEA imposed some additional requirements on dietary
 supplements, requiring companies to notify FDA when claims are made about
 beneficial effects on the structure or function of the body
 ("structure/function claims").  Marketers of conventional foods are not
 required to notify FDA when structure/function claims are made.
     Like foods, dietary supplements are required to be manufactured in
 accordance with Good Manufacturing Practices (GMPs), and plants are inspected
 by FDA to determine whether such practices are being followed.  Regulations
 describing food GMPs are set out in Title 21, Code of Federal Regulations,
 Part 110.  DSHEA authorized FDA to establish a set of GMPs specifically
 applying to dietary supplements.  The industry supports such GMPs and has
 supported FDA development of a new regulation, which is moving through the
 regulatory process.
     "Consumers are being bamboozled by some media and some health
 professionals who have an axe to grind against dietary supplements and who do
 not have a good understanding of legal and regulatory issues," said Annette
 Dickinson, Ph.D., CRN's Vice President for Scientific and Regulatory Affairs.
 "Irresponsible statements falsely charging that dietary supplements are
 unregulated are creating unnecessary concern among consumers and are grossly
 unfair to the industry.  This is especially outrageous when it relates to a
 serious issue such as BSE.  In fact, the industry is complying with U.S.
 import policies and is working with government agencies to ensure that
 consumers continue to be fully protected."
 
 SOURCE  Council for Responsible Nutrition