- 155,841
- 135,234
- Joined
- Oct 13, 2001
Link: http://www.naturalnews.co...ements_FDA_approval.html
I won't post the whole article, it scares folks. I will post the key points.
(NaturalNews) Yesterday we reported on the FDA's new scheme for outlawing nearly all nutritional supplements formulated after October, 1994 (http://www.naturalnews.com/032912_F...). That was just the beginning of this story, because a detailed analysis of the proposed new regulation reveals extremely disturbing revelations that would absolutely gut the nutritional products industry if these regulations are put into practice.
Below are the highlights of the most offensive and onerous portions of these proposed new FDA regulations. The source of all this information is the FDA itself, which proposes its new rules in a rather lengthy post at: http://www.fda.gov/Food/GuidanceCom...
• Every nutritional supplement company will be forced to submit comprehensive NDI (New Dietary Ingredient) documentation for EACH ingredient used in EACH product they currently sell. This will amount to hundreds of thousands of NDI applications flooding the FDA offices. This is a clever FDA scheme to place a huge burden of research and paperwork on every dietary supplement company in the USA. In the FDA's own words:
"The statute places the obligation for submitting the notification on each manufacturer or distributor. Any other manufacturer or distributor who wishes to market its own dietary supplement containing the same NDI should submit a NDI notification to FDA explaining its own basis for concluding that this new product containing the NDI will "reasonably expected to be safe" under the conditions recommended or suggested in the new product's labeling."
• All supplement companies must REMOVE their products from "interstate commerce" for the 75 days after the FDA receives their NDI applications. No product containing an NDI application ingredient may be sold in the United States or it will be considered "adulterated" by the FDA and thereby subjected to confiscation.
• While the NDI provisions of the 1994 DSHEA act merely required dietary supplement companies to notify the FDA of new ingredients, the FDA is now distorting this into a de facto supplement approval process. Without the FDA's new approval, nutritional supplements will all be labeled "adulterated" and potentially confiscated at gunpoint by the FDA (see FDA raid links below).
• The FDA does not support electronic filing for NDI applications. All applications must be done on paper and then mailed to the FDA (yes, as in dropped in a metal mailbox with a paper envelope). The 75 days of waiting does not begin until the FDA says it receives your application.
• While a few ingredients that were in widespread use before 1994 are exempted from these new requirements, the FDA refuses to publish any list of "grandfathered" ingredients. Instead, it requires each supplement company to figure it out for themselves. In addition, even pre-1994 ingredients must receive new approvals from the FDA if they are "altered" in any way, including changing the particle size, increasing the amount per serving, using a super-critical extraction process, baking the substance or even harvesting it from a plant at a different life stage of the plant. In other words, nearly all ingredients use in dietary supplements today are considered "adulterated" by the FDA.
• As a result of the point above, nearly all dietary ingredients will be required to receive new approval by the FDA due to the agency's broad definition of "adulterated." Note that changing the mg per serving of the nutrient makes it "adulterated," as does altering the target market. So if you sell vitamin C to senior citizens, and it's approved by the FDA as a dietary ingredient, you will need a NEW application and approval if you now sell that same vitamin C to children.
• The requirements for "proving" the safety and efficacy of dietary ingredients is entirely unreasonable. FDA says it requires companies to submit peer-reviewed scientific journal articles, clinical trial test results and even, in the case of botanicals, to provide the name of the scientist who originally gave the plant its Latin name. (Seriously? Is it a trick question?)
• The FDA has no obligation to "approve" any NDIs in a timely manner. It merely says it will acknowledge receipt of the NDI application within 75 days.
• If one company receives approval for a specific dietary ingredient (resveratrol, for example), that approval does NOT apply to any other company. EVERY company must independently apply for approval of resveratrol, and each company must independently supply all the research and documentation required to support the safety and efficacy of that ingredient in the amounts used in its products, and in the context of the marketing of that product.
• Companies that sell dietary supplements containing ingredients that have not been approved under these new FDA regulations will be accused of selling "adulterated" ingredients and can have their inventory seized by federal marshals or have their company founders arrested for selling "adulterated drugs" even though they might only be vitamins or herbs.
• These proposed regulations are NOT a law under the control of Congress. Neither the House nor the Senate has any control over this. The FDA can simply issue these regulations on its own, regardless of what publicly elected officials want the agency to do. The FDA is run by unelected bureaucrats who answer to no one and write their own "laws." (See attorney Jonathan Emord's book The Rise of Tyranny to learn more.)
• The FDA can simply choose to DENY all applications and thereby outlaw virtually all nutritional supplements. There is no obligation by the FDA to honestly and accurately review any applications whatsoever. It can simply rubber stamp 'DENIED' on every one of them. In the FDA's own words: "FDA's failure to respond to a NDI notification does not constitute a finding by the agency that the NDI or the dietary supplement containing the NDI is safe or is not adulterated."
• The real kicker in all this? Synthetic molecules that mimic dietary supplements (i.e. those used in pharmaceuticals) are EXEMPTED from all these requirements! So synthetic molecules need no approval from the FDA, while the natural ones do! This conveniently exempts the pharmaceutical vitamin companies who use synthetic vitamin chemicals rather than natural, full-spectrum nutrients.
Learn more: http://www.naturalnews.com/032924_dietary_supplements_FDA_approval.html#ixzz1RWKbwApR
I won't post the whole article, it scares folks. I will post the key points.
(NaturalNews) Yesterday we reported on the FDA's new scheme for outlawing nearly all nutritional supplements formulated after October, 1994 (http://www.naturalnews.com/032912_F...). That was just the beginning of this story, because a detailed analysis of the proposed new regulation reveals extremely disturbing revelations that would absolutely gut the nutritional products industry if these regulations are put into practice.
Below are the highlights of the most offensive and onerous portions of these proposed new FDA regulations. The source of all this information is the FDA itself, which proposes its new rules in a rather lengthy post at: http://www.fda.gov/Food/GuidanceCom...
• Every nutritional supplement company will be forced to submit comprehensive NDI (New Dietary Ingredient) documentation for EACH ingredient used in EACH product they currently sell. This will amount to hundreds of thousands of NDI applications flooding the FDA offices. This is a clever FDA scheme to place a huge burden of research and paperwork on every dietary supplement company in the USA. In the FDA's own words:
"The statute places the obligation for submitting the notification on each manufacturer or distributor. Any other manufacturer or distributor who wishes to market its own dietary supplement containing the same NDI should submit a NDI notification to FDA explaining its own basis for concluding that this new product containing the NDI will "reasonably expected to be safe" under the conditions recommended or suggested in the new product's labeling."
• All supplement companies must REMOVE their products from "interstate commerce" for the 75 days after the FDA receives their NDI applications. No product containing an NDI application ingredient may be sold in the United States or it will be considered "adulterated" by the FDA and thereby subjected to confiscation.
• While the NDI provisions of the 1994 DSHEA act merely required dietary supplement companies to notify the FDA of new ingredients, the FDA is now distorting this into a de facto supplement approval process. Without the FDA's new approval, nutritional supplements will all be labeled "adulterated" and potentially confiscated at gunpoint by the FDA (see FDA raid links below).
• The FDA does not support electronic filing for NDI applications. All applications must be done on paper and then mailed to the FDA (yes, as in dropped in a metal mailbox with a paper envelope). The 75 days of waiting does not begin until the FDA says it receives your application.
• While a few ingredients that were in widespread use before 1994 are exempted from these new requirements, the FDA refuses to publish any list of "grandfathered" ingredients. Instead, it requires each supplement company to figure it out for themselves. In addition, even pre-1994 ingredients must receive new approvals from the FDA if they are "altered" in any way, including changing the particle size, increasing the amount per serving, using a super-critical extraction process, baking the substance or even harvesting it from a plant at a different life stage of the plant. In other words, nearly all ingredients use in dietary supplements today are considered "adulterated" by the FDA.
• As a result of the point above, nearly all dietary ingredients will be required to receive new approval by the FDA due to the agency's broad definition of "adulterated." Note that changing the mg per serving of the nutrient makes it "adulterated," as does altering the target market. So if you sell vitamin C to senior citizens, and it's approved by the FDA as a dietary ingredient, you will need a NEW application and approval if you now sell that same vitamin C to children.
• The requirements for "proving" the safety and efficacy of dietary ingredients is entirely unreasonable. FDA says it requires companies to submit peer-reviewed scientific journal articles, clinical trial test results and even, in the case of botanicals, to provide the name of the scientist who originally gave the plant its Latin name. (Seriously? Is it a trick question?)
• The FDA has no obligation to "approve" any NDIs in a timely manner. It merely says it will acknowledge receipt of the NDI application within 75 days.
• If one company receives approval for a specific dietary ingredient (resveratrol, for example), that approval does NOT apply to any other company. EVERY company must independently apply for approval of resveratrol, and each company must independently supply all the research and documentation required to support the safety and efficacy of that ingredient in the amounts used in its products, and in the context of the marketing of that product.
• Companies that sell dietary supplements containing ingredients that have not been approved under these new FDA regulations will be accused of selling "adulterated" ingredients and can have their inventory seized by federal marshals or have their company founders arrested for selling "adulterated drugs" even though they might only be vitamins or herbs.
• These proposed regulations are NOT a law under the control of Congress. Neither the House nor the Senate has any control over this. The FDA can simply issue these regulations on its own, regardless of what publicly elected officials want the agency to do. The FDA is run by unelected bureaucrats who answer to no one and write their own "laws." (See attorney Jonathan Emord's book The Rise of Tyranny to learn more.)
• The FDA can simply choose to DENY all applications and thereby outlaw virtually all nutritional supplements. There is no obligation by the FDA to honestly and accurately review any applications whatsoever. It can simply rubber stamp 'DENIED' on every one of them. In the FDA's own words: "FDA's failure to respond to a NDI notification does not constitute a finding by the agency that the NDI or the dietary supplement containing the NDI is safe or is not adulterated."
• The real kicker in all this? Synthetic molecules that mimic dietary supplements (i.e. those used in pharmaceuticals) are EXEMPTED from all these requirements! So synthetic molecules need no approval from the FDA, while the natural ones do! This conveniently exempts the pharmaceutical vitamin companies who use synthetic vitamin chemicals rather than natural, full-spectrum nutrients.
Learn more: http://www.naturalnews.com/032924_dietary_supplements_FDA_approval.html#ixzz1RWKbwApR
