Answers (5)
1
The following information is from the textbook "Practical Applications in Sports Nutrition." The authors are Heather Hedrick Fink, Lisa A. Burgoon and Alan E. Mikesky.
"A dietary supplement as defined by the DSHEA of 1994 is a product (than tobacco) intended to supplement the diet that contains one or more of the following dietary ingredients: vitamin, mineral, herb or other botanical, amino acid, dietary substance to supplement the diet by increasing the total dietary intake, concentrate, metabolite, constituent, extract, or a combination of any of the above ingredients. Dietary supplements are not intended to be used as a food or as a sole item of a meal or diet, and these products must be labeled as a dietary supplement."
"Under DSHEA the supplement manufacturer is responsible for the safety of the product. However, the supplement manufacturer is not required to test its products for safety, nor does it have to prove that the supplement does what it claims to do."
In response to the question posed in the textbook, "What are the regulations governing dietary supplements?"
"Supplements are not drugs. Drugs are intended to cure, treat or prevent disease. Drugs must undergo extensive studies of safety and effectiveness, drug interactions, and dosing effects and must have formal FDA approval prior to marketing the product. On the other hand, dietary supplements do not have to undergo any studies on safety or efficacy prior to entering the market. Supplements are also not food additives, which require testing prior to entering the food marketplace. Dietary supplements containing any new ingredient do not require testing. The manufacturer gathers and interprets safety and efficacy information, and them must submit the product and safety information, and the must submit the product and safety information to the FDA 75 days prior to marketing the product. After the 75-day waiting period the supplement can be placed on the market. However, the FDA does not approve the new ingredient. New supplements that do not contain any new ingredients do not have to submit anything to the FDA prior to marketing the product."
Please excuse this lengthy post, however, I hope it is helpful to you.
"A dietary supplement as defined by the DSHEA of 1994 is a product (than tobacco) intended to supplement the diet that contains one or more of the following dietary ingredients: vitamin, mineral, herb or other botanical, amino acid, dietary substance to supplement the diet by increasing the total dietary intake, concentrate, metabolite, constituent, extract, or a combination of any of the above ingredients. Dietary supplements are not intended to be used as a food or as a sole item of a meal or diet, and these products must be labeled as a dietary supplement."
"Under DSHEA the supplement manufacturer is responsible for the safety of the product. However, the supplement manufacturer is not required to test its products for safety, nor does it have to prove that the supplement does what it claims to do."
In response to the question posed in the textbook, "What are the regulations governing dietary supplements?"
"Supplements are not drugs. Drugs are intended to cure, treat or prevent disease. Drugs must undergo extensive studies of safety and effectiveness, drug interactions, and dosing effects and must have formal FDA approval prior to marketing the product. On the other hand, dietary supplements do not have to undergo any studies on safety or efficacy prior to entering the market. Supplements are also not food additives, which require testing prior to entering the food marketplace. Dietary supplements containing any new ingredient do not require testing. The manufacturer gathers and interprets safety and efficacy information, and them must submit the product and safety information, and the must submit the product and safety information to the FDA 75 days prior to marketing the product. After the 75-day waiting period the supplement can be placed on the market. However, the FDA does not approve the new ingredient. New supplements that do not contain any new ingredients do not have to submit anything to the FDA prior to marketing the product."
Please excuse this lengthy post, however, I hope it is helpful to you.
0
Followed the link and read
"FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market."
Perhaps you should reword the blog statement more specifically to say the supplements are "not regulated by the FDA before they reach the market." Hope this helps the discussion.
"FDA is responsible for taking action against any unsafe dietary supplement product after it reaches the market."
Perhaps you should reword the blog statement more specifically to say the supplements are "not regulated by the FDA before they reach the market." Hope this helps the discussion.
0
"By law (DSHEA), the manufacturer is responsible for ensuring that its dietary supplement products are safe before they are marketed. Unlike drug products that must be proven safe and effective for their intended use before marketing, there are no provisions in the law for FDA to "approve" dietary supplements for safety or effectiveness before they reach the consumer."
Straight off of the most frequently asked questions from your link. They seem to spell it out with "...,there are no provisions in the law for FDA to "approve" dietary supplements for safety of effectiveness before they reach the consumer"
Seems pretty clear cut to me..they DON"T regulate supplements. I would quote and cite this type of information in this and other blogs in the future. It is never enough to state something that challenges somebodies core values without in your fact proof. Your blog posted a list of fact but no works cited...that does not convey accurate information it makes it an opinion and a strong one at that. Anything that has "fact" in it needs to have a source. If you had done this you wouldn't have had a problem.
Straight off of the most frequently asked questions from your link. They seem to spell it out with "...,there are no provisions in the law for FDA to "approve" dietary supplements for safety of effectiveness before they reach the consumer"
Seems pretty clear cut to me..they DON"T regulate supplements. I would quote and cite this type of information in this and other blogs in the future. It is never enough to state something that challenges somebodies core values without in your fact proof. Your blog posted a list of fact but no works cited...that does not convey accurate information it makes it an opinion and a strong one at that. Anything that has "fact" in it needs to have a source. If you had done this you wouldn't have had a problem.
0
Hi Marlan,
I reviewed all the links that you posted and can only agree with the other people who have already answered.
Another thing to consider is that the FDA will only act if there is something being brought against a supplement. Else it can be sold for years, and you can only that it does no harm. There are no requirements that manufacturers prove anything. I could put M&Ms in a bottle and sell them as the latest supplement against male pattern baldness.
I was also wondering what interest the person had who decided to take you to task about your blog. Do you know?
I reviewed all the links that you posted and can only agree with the other people who have already answered.
Another thing to consider is that the FDA will only act if there is something being brought against a supplement. Else it can be sold for years, and you can only that it does no harm. There are no requirements that manufacturers prove anything. I could put M&Ms in a bottle and sell them as the latest supplement against male pattern baldness.
I was also wondering what interest the person had who decided to take you to task about your blog. Do you know?
0
I'm pretty certain supplements are not regulated at all. Most have that Cross shape for their ingredients which means 'not evaluated for body daily intake'.
Until there is a supplement that causes a serious medical condition they'll most likely continue under the FDA's radar.
Until there is a supplement that causes a serious medical condition they'll most likely continue under the FDA's radar.
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