Masters Swimming and Illegal Supplements

Originally posted by aquageek Here you go Bob, straight from an article in today's NYT on something called bitter orange: The F.D.A. does not require manufacturers of dietary supplements to prove that the products are safe and effective before they are sold. We can parse right versus expectation all day but the simple fact remains that these supplements are not drugs, not regulated and many times not safe. But, feel free to part with you hard earned dollars to take them. Wrong again! You are correct that supplements are not drugs and are therefore not (as the NYT article said) required to spend millions of dollars proving safety and efficacy to the FDA. But they are regulated in the same way that foods are. And that means that they are required by law to list ingredients. Since you've brought up the whole subject of FDA regulation of drugs, I should clarify the situation for those who may not be familiar with the process. When a company wants to introduce a new drug, the first thing they do is patent it, which gives them exclusive rights to produce it for 18 years. They then begin the long and expensive process of carrying out studies to prove its safety and efficacy to the FDA's satisfaction. Note that it is not enough just to prove that the drug is safe. They must also, to the FDA's satisfaction, prove its efficacy in treating some disease. The drug manufacturer essentially gambles that they will complete this process with enough of their 18 year patent left to recoup the millions of dollars they have spent satisfying the FDA's standards before the patent expires and other companies are allowed to compete by producing generic versions of the same drug. What is ironic about this is that once a drug has received approval for treating some disease, doctors are free to prescribe it for any reason they choose, regardless of whether the disease it is being used to treat is one for which it has received FDA approval. Thus, we can have two drugs, which we'll call A and B, both of which have been shown to be safe, but neither of which have been proven, to the FDA's satisfaction, to be effective in treating disease X. But because drug A has been proven, to the FDA's satisfaction, to be efficacious in treating another disease, a doctor can prescribe it for the treatment of disease X, but he cannot prescribe drug B for treatment of the same disease, even though there may be more evidence that drug B is beneficial in treating disease X, and even though drug B may actually be in use for that purpose in other countries. Industry experts have estimated that the cost of gaining approval for a new drug would be substantially reduced if the manufacturer only had to demonstrate safety, leaving it to doctors to determine whether its efficacy had been adequately demonstrated for a particular disease before prescribing it. As it is, the additional costs of proving efficacy are passed along to consumers in the form of high drug prices. If supplements were to be regulated in the same way, there would be one important difference: Supplements, by definition, cannot be patented. Consequently, a manufacturer who spent millions of dollars demonstrating a supplement's safety and efficacy to the FDA's satisfaction would never be able to recoup their expenses, since they would have no period of exclusive right to production during which they could charge an inflated price. Bob

Originally posted by aquageek Here you go Bob, straight from an article in today's NYT on something called bitter orange: The F.D.A. does not require manufacturers of dietary supplements to prove that the products are safe and effective before they are sold. We can parse right versus expectation all day but the simple fact remains that these supplements are not drugs, not regulated and many times not safe. But, feel free to part with you hard earned dollars to take them. Wrong again! You are correct that supplements are not drugs and are therefore not (as the NYT article said) required to spend millions of dollars proving safety and efficacy to the FDA. But they are regulated in the same way that foods are. And that means that they are required by law to list ingredients. Since you've brought up the whole subject of FDA regulation of drugs, I should clarify the situation for those who may not be familiar with the process. When a company wants to introduce a new drug, the first thing they do is patent it, which gives them exclusive rights to produce it for 18 years. They then begin the long and expensive process of carrying out studies to prove its safety and efficacy to the FDA's satisfaction. Note that it is not enough just to prove that the drug is safe. They must also, to the FDA's satisfaction, prove its efficacy in treating some disease. The drug manufacturer essentially gambles that they will complete this process with enough of their 18 year patent left to recoup the millions of dollars they have spent satisfying the FDA's standards before the patent expires and other companies are allowed to compete by producing generic versions of the same drug. What is ironic about this is that once a drug has received approval for treating some disease, doctors are free to prescribe it for any reason they choose, regardless of whether the disease it is being used to treat is one for which it has received FDA approval. Thus, we can have two drugs, which we'll call A and B, both of which have been shown to be safe, but neither of which have been proven, to the FDA's satisfaction, to be effective in treating disease X. But because drug A has been proven, to the FDA's satisfaction, to be efficacious in treating another disease, a doctor can prescribe it for the treatment of disease X, but he cannot prescribe drug B for treatment of the same disease, even though there may be more evidence that drug B is beneficial in treating disease X, and even though drug B may actually be in use for that purpose in other countries. Industry experts have estimated that the cost of gaining approval for a new drug would be substantially reduced if the manufacturer only had to demonstrate safety, leaving it to doctors to determine whether its efficacy had been adequately demonstrated for a particular disease before prescribing it. As it is, the additional costs of proving efficacy are passed along to consumers in the form of high drug prices. If supplements were to be regulated in the same way, there would be one important difference: Supplements, by definition, cannot be patented. Consequently, a manufacturer who spent millions of dollars demonstrating a supplement's safety and efficacy to the FDA's satisfaction would never be able to recoup their expenses, since they would have no period of exclusive right to production during which they could charge an inflated price. Bob