Eureka! I know how to fix the DSHEA supplement law
FOR IMMEDIATE RELEASE Media Inquiries: 301-827-6242P04-101 Consumer Inquiries: 888-INFO-FDA
November 4, 2004
FDA ANNOUNCES MAJOR INITIATVES FOR DIETARY SUPPLEMENTS
.................................
The FDA appears to be trying to make some sense and rationality of DSHEA. Admirable. I make some points below as to why FDA will still not be able to do all that is right by it. The FDA should do what it can to get the DSHEA law changed, perhaps they are or intend to.
FDA classifications/definitions of a "food," "food additive," and "drug" are not based on what the product is, but for what use it is intended. They are labeled for how or why they are used. This is not the case for the DSHEA derived classification of "dietary supplement," which is based a definition of what they are. Thus, DSHEA can allow a food, a food additive, or a drug (by definition) to be reclassified and sold as a nutritional supplement that is not subject to regulations of these other classifications.
An obvious fix is to further define "dietary supplement" by how and why it is intended to be used. How about something like: "intended to supplement, improve or increase the healthiness or nutritional aspects of one's diet."
Right away this excludes all the DSHEA protected "natural" male enhancement, "energy," hair growth, hormone and weight loss products, just to mention a few. It leaves alone the products for which DSHEA was advocated, namely, vitamins, minerals, amino acids, and basically those things for which the USDA has RDA's. In the least, these products can be labeled "When taken as labeled, (product) can promote good nutrition for better health throughout life."
What's to be done with all the "natural" health remedies included in DSHEA but are excluded from my proposed definition? Make a new classification like "traditional health remedy" with label and advertising requirements that clearly state that these products "may contain active ingredients with drug-like properties for which safety and efficacy have not been established for any health condition. Taking traditional health remedies may be dangerous, especially to those with chronic health conditions (blah, blah.) Tell your doctor about any health remedies you choose to use." Also, make manufactures and marketers set up an adverse event reporting system and bank for research into these products, etc, etc.
Per the press release:
"...FDA will also implement a transparent, systematic, and predictable process to evaluate safety concerns about dietary ingredients and dietary supplements. The process begins with a "signal detection" (identifying an issue of concern). Signals of a possible safety concern can come from Federal, state and local counterparts; adverse event reports; foreign regulatory actions; media reports; information from consumer groups; and consultation with experts. ..."
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Why put this burden on government and consumer groups? Why aren't marketers and manufacturers obligated to solicit, record, or report adverse events possibly associated with their products.
---------------------------------------------------------------------------------
"...FDA has a variety of options for pursuing its public health mission, including making a determination of unreasonable risk, issuing public health advisories, educating consumers, conducting research, and requiring labeling changes...."
----------------------------------------------------------------------------------
Besides being coerced into making a labeling change, where is the manufacturer or marketer's obligation or responsibility in assessing risk, educating consumers, or conducting research?
..............
One big problem with DSHEA is that is classifies a product centered around what it is. Conversely, The Act classifies a food, food additive, or a drug by why it is used. "Used to supplement the diet" does not infer WHY a supplement would be used. If it is not used to influence a structure/function of the body like a drug, is not a food source like food, and is not added to foods like a food additive, what is it for? Now we have artificial sweeteners (an additive by obvious definition) marketed as a dietary supplement (as long as it's not packaged with food.) We have myriads of products chemically similar to classified drugs marketed as dietary supplements (as long as they don't make a real health claim.) We have a hole Health vocabulary of complete ambiguity uniquely structured to avoid health claims about structure/function.
Another DSHEA shortcoming is that it essentially allows manufacturers to package up about any item and sell it without much obligation to identify or accept liability for it's safety, or to discover any real impact to human physiology.
Lastly, a big DSHEA misstep is that it requires nowhere near the manufacturing or quality control standards that food additives or drugs are subject to. They are less than foods in most cases. Contents are not even guarenteed.
Goals of a new DSHEA. 1. Protect the public against dangerous health effects of unlabeled products that physiologically influence a body function or structure. 2. Prevent the health fraud of snake-oil marketing tactics. 3. Prevent repercussions of a mass placebo/nocebo effect that could happen should many current supplements be removed from the market.
Things a new DSHEA should do. 1. Disqualify manufactured products that concentrate or compound natural ingredients (usually to enhance a pharmacological effect) beyond what would be commonly available or usable in the natural form. 2. Labeling centered around health warnings of the fact that the natural product is a traditional health remedy for which safety and efficacy have not been established. 3. Require manufacturer's/marketers to maintain an adverse event reporting system for compounded, proprietary, or unique products similar to that used for drugs. (FDA could set up a system for "generics".)
Things a new DSHEA should not do. 1. Cause rampant disqualification of current supplements from the market. 2. Allow packaged powders, pills, elixirs, etc. to bypass quality of manufacturing or production and/or ingredient (chemical makeup) and labeling standards similarly in place for processed foods. 3. Bunch a 350mg vitamin C tablet in the same regulatory class with the latest proprietary blend "all-natural" ingredients marketed to "restore vigor, enhance the body's natural ability, etc."
November 4, 2004
FDA ANNOUNCES MAJOR INITIATVES FOR DIETARY SUPPLEMENTS
.................................
The FDA appears to be trying to make some sense and rationality of DSHEA. Admirable. I make some points below as to why FDA will still not be able to do all that is right by it. The FDA should do what it can to get the DSHEA law changed, perhaps they are or intend to.
FDA classifications/definitions of a "food," "food additive," and "drug" are not based on what the product is, but for what use it is intended. They are labeled for how or why they are used. This is not the case for the DSHEA derived classification of "dietary supplement," which is based a definition of what they are. Thus, DSHEA can allow a food, a food additive, or a drug (by definition) to be reclassified and sold as a nutritional supplement that is not subject to regulations of these other classifications.
An obvious fix is to further define "dietary supplement" by how and why it is intended to be used. How about something like: "intended to supplement, improve or increase the healthiness or nutritional aspects of one's diet."
Right away this excludes all the DSHEA protected "natural" male enhancement, "energy," hair growth, hormone and weight loss products, just to mention a few. It leaves alone the products for which DSHEA was advocated, namely, vitamins, minerals, amino acids, and basically those things for which the USDA has RDA's. In the least, these products can be labeled "When taken as labeled, (product) can promote good nutrition for better health throughout life."
What's to be done with all the "natural" health remedies included in DSHEA but are excluded from my proposed definition? Make a new classification like "traditional health remedy" with label and advertising requirements that clearly state that these products "may contain active ingredients with drug-like properties for which safety and efficacy have not been established for any health condition. Taking traditional health remedies may be dangerous, especially to those with chronic health conditions (blah, blah.) Tell your doctor about any health remedies you choose to use." Also, make manufactures and marketers set up an adverse event reporting system and bank for research into these products, etc, etc.
Per the press release:
"...FDA will also implement a transparent, systematic, and predictable process to evaluate safety concerns about dietary ingredients and dietary supplements. The process begins with a "signal detection" (identifying an issue of concern). Signals of a possible safety concern can come from Federal, state and local counterparts; adverse event reports; foreign regulatory actions; media reports; information from consumer groups; and consultation with experts. ..."
---------------------------------------------------------------------------------
Why put this burden on government and consumer groups? Why aren't marketers and manufacturers obligated to solicit, record, or report adverse events possibly associated with their products.
---------------------------------------------------------------------------------
"...FDA has a variety of options for pursuing its public health mission, including making a determination of unreasonable risk, issuing public health advisories, educating consumers, conducting research, and requiring labeling changes...."
----------------------------------------------------------------------------------
Besides being coerced into making a labeling change, where is the manufacturer or marketer's obligation or responsibility in assessing risk, educating consumers, or conducting research?
..............
One big problem with DSHEA is that is classifies a product centered around what it is. Conversely, The Act classifies a food, food additive, or a drug by why it is used. "Used to supplement the diet" does not infer WHY a supplement would be used. If it is not used to influence a structure/function of the body like a drug, is not a food source like food, and is not added to foods like a food additive, what is it for? Now we have artificial sweeteners (an additive by obvious definition) marketed as a dietary supplement (as long as it's not packaged with food.) We have myriads of products chemically similar to classified drugs marketed as dietary supplements (as long as they don't make a real health claim.) We have a hole Health vocabulary of complete ambiguity uniquely structured to avoid health claims about structure/function.
Another DSHEA shortcoming is that it essentially allows manufacturers to package up about any item and sell it without much obligation to identify or accept liability for it's safety, or to discover any real impact to human physiology.
Lastly, a big DSHEA misstep is that it requires nowhere near the manufacturing or quality control standards that food additives or drugs are subject to. They are less than foods in most cases. Contents are not even guarenteed.
Goals of a new DSHEA. 1. Protect the public against dangerous health effects of unlabeled products that physiologically influence a body function or structure. 2. Prevent the health fraud of snake-oil marketing tactics. 3. Prevent repercussions of a mass placebo/nocebo effect that could happen should many current supplements be removed from the market.
Things a new DSHEA should do. 1. Disqualify manufactured products that concentrate or compound natural ingredients (usually to enhance a pharmacological effect) beyond what would be commonly available or usable in the natural form. 2. Labeling centered around health warnings of the fact that the natural product is a traditional health remedy for which safety and efficacy have not been established. 3. Require manufacturer's/marketers to maintain an adverse event reporting system for compounded, proprietary, or unique products similar to that used for drugs. (FDA could set up a system for "generics".)
Things a new DSHEA should not do. 1. Cause rampant disqualification of current supplements from the market. 2. Allow packaged powders, pills, elixirs, etc. to bypass quality of manufacturing or production and/or ingredient (chemical makeup) and labeling standards similarly in place for processed foods. 3. Bunch a 350mg vitamin C tablet in the same regulatory class with the latest proprietary blend "all-natural" ingredients marketed to "restore vigor, enhance the body's natural ability, etc."
posted by nawledge at
9:31 PM
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