Originally posted by BettorsChat
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Originally posted by winnerDo you have any links to the amount of money the supplement industry donates to politicians? I can't believe it is too much as it's always been an unregulated industry. Right or wrong. I would imagine there are more monies donated from legit big-pharma companies that rinky dink supplement companies selling snake oil and the next fountain of youth.
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It is a billion dollar a year industry, but I believe it's spread out in many very small companies pitching the next big thing. They stay in business a year or two, sell their crap, and move on. It's not an industry like tobacco or oil where there are only a few large companies controlling everything. I don't think the people who make Flintstones vitamins are bribing high gov't officials to keep them from being regulated. Just my opinion though. No personal experiences with the Flintstone folks and they haven't given me any facts.
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Originally posted by winnerIt is a billion dollar a year industry, but I believe it's spread out in many very small companies pitching the next big thing. They stay in business a year or two, sell their crap, and move on. It's not an industry like tobacco or oil where there are only a few large companies controlling everything. I don't think the people who make Flintstones vitamins are bribing high gov't officials to keep them from being regulated. Just my opinion though. No personal experiences with the Flintstone folks and they haven't given me any facts.
Go open up a Fitness magazine and look at all of the ads in there. Numerous companies around that have been bilking the industry for years. Joe Weider is an example of someone that's in this industry.
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Q. Who is the dietary supplement industry?
A. In the U.S., the dietary supplement industry is a $20 billion industry. According to the most recent statistics from the Food and Drug Administration (FDA), there are 29,000 dietary supplement products on the market, up from 25,000 in 1993. Dietary supplement products include vitamins, minerals, botanicals, sports nutrition supplements, weight management products, and specialty supplements. These products are intended to be used as supplements to, not substitutes for, a well-balanced diet and a healthy lifestyle. When used properly, they help promote overall good health and prevent disease. More than 150 million Americans take dietary supplements annually.
Q. Is the dietary supplement industry regulated?
A. Yes. The dietary supplement industry is regulated by FDA and the Federal Trade Commission (FTC), as well as by government agencies in each of the 50 states. The FDA has regulatory authority under the Dietary Supplement Health and Education Act (DSHEA), a 1994 amendment to the Federal Food, Drug and Cosmetic Act that was passed by unanimous consent in both the House and Senate.
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Q. Why do some people say the industry is unregulated?
A. When critics say dietary supplements are "unregulated," what they generally mean is that dietary supplements are not regulated like drugs. Dietary supplements have always been regulated as a category of food in this country, and DSHEA did not change that fact. Virtually all facets of dietary supplement manufacturing, labeling and marketing are covered by extensive regulations issued and enforced by FDA and FTC. If dietary supplements were regulated like drugs, there would likely be no dietary supplement industry and the products that did exist would cost what drugs cost.
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Originally posted by winnerQ. Who is the dietary supplement industry?
A. In the U.S., the dietary supplement industry is a $20 billion industry. According to the most recent statistics from the Food and Drug Administration (FDA), there are 29,000 dietary supplement products on the market, up from 25,000 in 1993. Dietary supplement products include vitamins, minerals, botanicals, sports nutrition supplements, weight management products, and specialty supplements. These products are intended to be used as supplements to, not substitutes for, a well-balanced diet and a healthy lifestyle. When used properly, they help promote overall good health and prevent disease. More than 150 million Americans take dietary supplements annually.
Q. Is the dietary supplement industry regulated?
A. Yes. The dietary supplement industry is regulated by FDA and the Federal Trade Commission (FTC), as well as by government agencies in each of the 50 states. The FDA has regulatory authority under the Dietary Supplement Health and Education Act (DSHEA), a 1994 amendment to the Federal Food, Drug and Cosmetic Act that was passed by unanimous consent in both the House and Senate.
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Q. Why do some people say the industry is unregulated?
A. When critics say dietary supplements are "unregulated," what they generally mean is that dietary supplements are not regulated like drugs. Dietary supplements have always been regulated as a category of food in this country, and DSHEA did not change that fact. Virtually all facets of dietary supplement manufacturing, labeling and marketing are covered by extensive regulations issued and enforced by FDA and FTC. If dietary supplements were regulated like drugs, there would likely be no dietary supplement industry and the products that did exist would cost what drugs cost.
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Originally posted by BettorsChatIt's not regulated! They don't test any of the products with by any means of a non biased party like the FDA etc.
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Originally posted by TwoTonTonyit is non-regulated, but many of the larger companies make pharmaceutical grade vitamins, which means they put themselves under similar scrutiny as the FDA in terms of consistency, etc.....Many vitamins can say they have a certain ingredient but they do not have to disclose the amount of the ingredient, in fact many have proprietary blends for this very reason.....But like i said many of the larger companies are much more reliable....I have a friend who sold his vitamin company for $10 million dollars to twinlab or prolab....i forgot.....And another friend who us the largest vitamin exporter in the world and also represents Instone (stallones products)....
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1994 Dietary Supplement Health and Education Act, or DSHEA, which set up a new framework for FDA regulation of dietary supplements. It also created an office in the National Institutes of Health to coordinate research on dietary supplements, and it called on President Clinton to set up an independent dietary supplement commission to report on the use of claims in dietary supplement labeling.
But in choosing whether to use dietary supplements, FDA answers consumers' questions by noting that under DSHEA, FDA's requirement for premarket review of dietary supplements is less than that over other products it regulates, such as drugs and many additives used in conventional foods.
This requires manufacturers to conduct safety studies and submit the results to FDA for review before the ingredient can be used in marketed products. Based on its review, FDA either authorizes or rejects the food additive.
Under DSHEA, once a dietary supplement is marketed, FDA has the responsibility for showing that a dietary supplement is unsafe before it can take action to restrict the product's use. This was the case when, in June 1997, FDA proposed, among other things, to limit the amount of ephedrine alkaloids in dietary supplements (marketed as ephedra, Ma huang, Chinese ephedra, and epitonin, for example) and provide warnings to consumers about hazards associated with use of dietary supplements containing the ingredients.
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Originally posted by BettorsChatReason why they can scapegoat around no FDA approval or proven clinical trials is because of the lobbyist that get paid to convince our elected Government officials to allow this which is BS.
When it comes to medicine there are a lot of European drugs that work that we have to wait years on over here, because it takes so long with the FDA and clinical trials. However, over the counter crap is totally different which it shouldn't be.
However you are correct that products in Europe seem to get to market sooner than here.....But i do not know if that is better or worse......In the US the drug has to go through extensive clinical trials all the way through Phase III which is on humans.....I think it is diligent that it is done this way since many compounds adverse events are not apparent for years......And then if we release them to market we would be hearing from the same people, "how could we let these drugs on the market so soon.....THE FDA is being paid off by BIG PHARMA and so on and so on......Way too many conspiracy theories for me to contend with.....However, there is an improper relatinship between the 2, but is there a better system??? i am not smart enough to say....
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Q. Is it true that before DSHEA was passed, FDA had pre-market approval authority?
A. No. FDA never had pre-market approval over dietary supplements, and DSHEA did not change that fact. Under the law, dietary supplements marketed in the U.S. before passage of DSHEA are "grandfathered" and assumed to have a history of safe use. If a supplement manufacturer wants to introduce a new ingredient, it must provide FDA with 75 days notice, along with safety information. If FDA has any concerns about the ingredient or submitted safety profile, the agency can request more information or deny the product’s entry into the marketplace. Since the passage of DSHEA, FDA has turned down about half of the New Dietary Ingredient notifications filed.
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Q. Without pre-market approval, how do we know these products are safe?
A. Pre-market approval is not a guarantee of safety as witnessed by those drug products that have been approved by FDA, only to be later recalled due to safety concerns. Like food products, dietary supplements do not undergo pre-market approval, but that does not mean that companies don’t do testing, or that products are unsafe. There are provisions under DSHEA that help protect consumers from potentially unsafe products. But, the overwhelming majority of dietary supplements are safely used by 150 million Americans annually.
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Q. What did DSHEA do?
A. DSHEA specifically reaffirmed the status of dietary supplements as a category of food and created a specific definition for dietary supplements. Further, DSHEA provided FDA with additional enforcement authority, including the ability to remove from the market products the agency deems unsafe through: 1) an "imminent hazard" clause which permits FDA to immediately remove a product it considers to present an immediate safety concern and 2) a "significant or unreasonable risk" clause that allows removal of a product considered to pose an unacceptable risk of illness or injury.
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Q. Shouldn’t companies have to abide by Good Manufacturing Practices (GMPs)?
A. Absolutely. Companies are required to abide by food GMPs while FDA finalizes its rule for GMPs specific to dietary supplements. Responsible companies do abide by GMPs–and many observe procedures which go above and beyond what the current GMPs require. Responsible companies in the industry fully support the need for the final GMP rule in order to create a level playing field for companies across the board and help increase consumer confidence in these products. FDA anticipates the final rule will be issued this year and as far as industry is concerned, the sooner, the better.
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Q. What is CRN’s position on reporting of adverse events?
A. CRN supports legislation for mandatory reporting of serious adverse events on a Federal level, allowing for industry involvement in developing a system that provides meaningful information while not inappropriately overburdening FDA or manufacturers. In addition, CRN is continuing to work with and encourage its members to explore ways to improve the industry’s overall management of adverse event reports.
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Q. Is DSHEA a good law?
A. Yes. DSHEA provides an appropriate framework for regulating the dietary supplement industry–as long as it is enforced. In the past several years, FDA has actively engaged in more vigorous implementation of DSHEA and stronger enforcement actions – these efforts are encouraged and supported by the mainstream dietary supplement industry. Even top officials at FDA have stated they are not asking Congress to change the law, noting they have adequate authority to remove unsafe supplements from the market. DSHEA provides FDA with appropriate regulatory authority while still allowing consumers to have the desired access to a wide variety of affordable, high quality, safe and beneficial dietary supplement products
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Originally posted by BettorsChatTheres a very high markup in that industry. The food industry is also in the same category. They don't list or mis-label what is in foods.
Vitamins are not as high a markup as you may think......In fact on the large distribution level it is 5-7%....Manufacturing however is larger of course, but the industry has drastically changed in the last 10 years and there are no more small players and the cost to bring a product to market is huge now......The advertsing and marketing is staggering......The market has gotten so saturated in the US it is hard to make $$$$, that is why my friend is a Exporter in emerging market countries....There the products are regualted and it is a hassle and large investment to di business there, so he was first to market and faces little competition......
Food/Grocery is very small markup business.....I sold a product in large grocery chains in the Northeast and you had better be pumping units, because it is costly in terms of slotting fees, breakage and seasonal returns, which all favors the store....Also some have a scan and pay policy which means they only pay the vendor when the product scans.....
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Originally posted by TwoTonTonywell, i believe you would be hard pressed to find food products without labelng anymore....
Vitamins are not as high a markup as you may think......In fact on the large distribution level it is 5-7%....Manufacturing however is larger of course, but the industry has drastically changed in the last 10 years and there are no more small players and the cost to bring a product to market is huge now......The advertsing and marketing is staggering......The market has gotten so saturated in the US it is hard to make $$$$, that is why my friend is a Exporter in emerging market countries....There the products are regualted and it is a hassle and large investment to di business there, so he was first to market and faces little competition......
Food/Grocery is very small markup business.....I sold a product in large grocery chains in the Northeast and you had better be pumping units, because it is costly in terms of slotting fees, breakage and seasonal returns, which all favors the store....Also some have a scan and pay policy which means they only pay the vendor when the product scans.....
And as for drugs I took one back in 1990 that had been used in Europe since the 60's. However here in the USA it took until 1990 for it to just be experimental.
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