We have all seen this statement. It is on supplement labels and at the bottom of any product that may state a structure or benefit claim for its use. The vocabulary we are talking about is “The Food and Drug Administration has not evaluated this statement. This product is not intended to diagnose, treat, cure or prevent any disease."
Just precisely what does this statement mean -- that the product doesn’t work? That it hasn’t been studied? What do you think about when you read this? Essentially, we deal with the FDA’s mantra of irresponsibility. History of the “Disclaimer Statement” Usher in the Bill Clinton Years, we can find the Dietary Supplement Health and Education Act, or DSHEA of 1994, where the “Disclaimer Statement” first appears. Because of a manufacturing glitch and the notorious “tryptophan” scare where hundreds of people became ill from contaminated tryptophan supplement pills, a task force was subsequently engaged after this tragedy. There it was recommended that the FDA maintain tighter control of the supplement and health claim industry. It was out of the DSHEA Act that the “Disclaimer Statement” emerged. Enter the Industry Lobbying. The industries became heavily involved in the passage of the DSHEA Act and claimed that supplements could be taken off the market if the act were passed in the format the task force had advised, thus scaring the public that they might lose their right to buy nutraceuticals. The industry's voices grew stronger, and the DSHEA Act's words became softer. This created a division between how drugs and supplements or health claims were treated. The stricter regulations the task force had recommended for the FDA gave way to the allowance of “structure and function” claims for health products. Drugs would still have to follow the FDA’s regulatory pathway, including animal testing, clinical trials, pre-marketing evaluations, safety protocols, etc., while structure and function claims would be allowed with proof supplied by the manufacturer. Health claims, nutrient-content claims and structure-function claims are the three claims allowed and must be followed by the “Disclaimer Statement.” What is interesting is that health claims must submit scientific evidence for validation of the claim to the FDA, yet even after this validation the "Disclaimer Statement" must be listed. What are Structure and Function Claims? A structure/function claim describes the role of a substance intended to maintain the structure or function of the body and still requires a statement that FDA has not evaluated the claim. This is so even if the company has proof that the structure function claim is true. Really, does, this make any sense? On the other hand, a health claim needs to go through the rigors of the FDA and be authorized by them before it can legally be present on the label. Then, it also must carry the “Disclaimer Statement.” It signals to consumers that they must determine for themselves if therapy is effective or not. It is essentially the FDA's way of showing a lack of responsibility for any claim made that bears this “disclaimer statement.” For example, it is okay to say that vitamin C supports a healthy immune system but not that it cures colds or reduces symptoms. Or a product promotes healthy cholesterol levels but does not lower them, even if studies say it does. Does a Disclaimer Statement Mean You Can’t Trust the Claim? No. A disclaimer statement only means the information was not provided to the FDA to evaluate the safety and effectiveness of the claim being made. The claim may be backed up by animal or human studies and very well may be true but it has not gone through the expensive rigors of FDA evaluation in a manner that a pharmaceutical drug would go through. And, FDA says it is not their jurisdiction. On the other hand, making any claim without evidence or oversight opens the door for charlatans to misuse information and fool an unwitting public. Even so-called “qualified health claims” supported by clinical evidence must be accompanied by the “Disclaimer Statement,” leaving it up to the consumer to determine the level of evidence present to verify the claim being made. Basically, the “Disclaimer Statement” is the FDA’s way of taking no responsibility for the claim, true or not.
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