Updated: October 18, 2005

"Whenever there is a disease or condition that many people will pay good money to relieve, there will be someone trying to turn a quick buck. In obesity, there are too many products or services that have been found to be harmful or are under current investigation."

American Obesity Association (AOA) - Consumer Alert Section

The Federal Drug Administration (FDA) regulates and controls all prescription medications brought to the marketplace in the United States. Unfortunately, that charter does not extend to control and regulation of "diet supplements" and vitamins. As defined by Congress and the FDA in the Dietary Supplement Health and Education Act (DSHEA) of 1994, a dietary supplement is "a product taken by mouth that contains a 'dietary ingredient' intended to supplement the diet. The 'dietary ingredients' in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of 'foods,' not drugs, and requires that every supplement be labeled a dietary supplement."

Since dietary supplements are considered "foods," the FDA has a limited control over their advertising claims and marketing. According to information posted on the FDA web site:

"Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.

Also, manufacturers do not need to register themselves nor their dietary supplement products with FDA before producing or selling them. Currently, there are no FDA regulations that are specific to dietary supplements that establish a minimum standard of practice for manufacturing dietary supplements. However, FDA intends to issue regulations on good manufacturing practices that will focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements. At present, the manufacturer is responsible for establishing its own manufacturing practice guidelines to ensure that the dietary supplements it produces are safe and contain the ingredients listed on the label." [Emphasis is mine]

Under this lack of regulatory control, unscrupulous manufacturers continue to churn out "weight loss miracle" cures and "secret" remedies that make exaggerated claims of success. Often, these concoctions are simply harmless combinations of vitamins and other food products. Sometimes, however, these products can actually be significantly harmful when used, particularly without the knowledge of your physician. Combining some of these compounds with prescription medications from your doctor can be lethal.

The most frightening thing about over-the-counter products, especially those labeled as "all herbal," is that the unsuspecting consumer assumes they are safe. Since they are "just herbs." they clearly can't affect the physiology of the body. And, equally importantly, consumers think they are somehow protected by the FDA since the FDA regulates what prescription medications can be sold to the American public. The FDA admits their lack of control of the OTC marketplace:

"Except for those dietary supplements containing new dietary ingredients, the safety and labeling of most dietary supplements is monitored only after they reach the marketplace. The FDA evaluates the safety of dietary supplements after they are on the market, overseeing safety, manufacturing, and product information on the labeling. The FTC regulates the advertising of dietary supplements under the FTC Act, which prohibits deceptive claims in advertising."

But, unlike prescriptions that must go through rigorous testing and multiple phases of human trials before these can be released for use in the general public, products brought out under the "food supplement" loophole do not have to prove anything. They do not have to be tested in animals, much less humans, before they can be sold. All too often, this can lead to disastrous results. Here is what the FDA says on their own web site about OTC products and their limited control:

"The law that governs how FDA can regulate dietary supplements, the Dietary Supplement Health and Education Act (DSHEA), requires FDA to do a lot of hard work with limited tools in order to determine that a dietary supplement is too unsafe to be marketed. In contrast to drugs, which must be proven safe and effective to be marketed, DSHEA requires FDA to develop evidence post marketing that a dietary supplement presents an "unreasonable risk of illness or injury." But FDA has no authority to require any studies of safety or effectiveness, or even to obtain reports of adverse events from manufacturers."

In 1997, the FDA began the slow process of evaluating the many weight loss products on the market that contained ephedra (or, ephedrine or simply under its herbal name, ma huang). This "herb" - in fact, a significantly active drug - raised blood pressure and pulse rate to dangerous levels. Ephedra was being used as the "active ingredient" of dozens of the OTC weight loss products, including Metabolife™, it's knock-off Metab-O- Lite™, BioLean™, and Hydroxycut™, among others. They issued some restrictions on the compounding and the directions for use of these products. Unfortunately, use of the ephedra compounds, especially dangerously combined with caffeine and the stimulant phenylpropanolamine. Unfortunately, the FDA did not have the evidence or the power to act more decisively and take the compound off the market entirely. It would prove to be a significant error.

Eventually, the FDA got all the evidence they needed. People starting dying. You may recall, in 2002, when it all came to a head. There was a flurry of news stories (like it was actually "news") about the use of ephedra in OTC diet "remedies." It wasn't too long before the FDA was receiving reports from doctors, emergency rooms and hospitals about patients dying from strokes and heart attacks while taking this "safe" herbal product. It took months, but the FDA machinery finally acted in late 2003 to remove ephedra (in it's many names) out of all OTC products.

[Addendum, April 19, 2005 Apparently, the federal court believed the FDA overstepped its legal authority when it banned the usage of ephedra from over-the-counter remedies. And, as a result, the federal courts ruled that the FDA must review ephedra and its safety. So, as only can happen in this great country of ours, we may see ephedra back on the market again. Let the strokes begin!]

Currently, the "active ingredient" in most of the newer generation OTC products for weight loss (RelaCort™, CortiSlim™, etc.) is some combination of caffeine, "green tea extract" (2) and chromium picolinate. Most also include a few vitamins (B12 seems to be very popular), gensing, saw palmetto, cinchona tree bark (or is it the chinchona tree roots?), or some other plant extracts are usually thrown in for good measure. Neither green tea or chromium have ever been shown, in comprehensive human testing, to affect weight loss or, more importantly, body composition. (1)

Recently, the FDA sent a letter to a distributor of the OTC "Xenadrine CarboCurb™" apparently questioning their advertising statement and "asking" them to cease and desist from making the unsubstantiated claims they were making on their web site about this product. I visited this web site recently and found their "research" claims have been changed. In its list of ingredients, it contains, among other things, "fermented sage," green tea and coffee, and "other methylxanthines." It is purported to "burn fat." They do, commendably, display some warning messages on their site about taking more than 4 tablets a day and that each tablet has the equivalent caffeine and "related methylxanthines" of one cup of coffee. I am not sure what is better: 4 cups of coffee or 4 tablets of this product. I am not at all sure either will "burn fat." The site now includes a disclaimer that reads:

"FDA Disclaimer: These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure or prevent any disease."

Personally and professionally, I beg you to be extremely careful when using any of the 50-60 products currently available, without prescription, for weight loss. All of them have some ingredients that may, if you are vulnerable, significantly raise your blood pressure and pulse. They have also been shown to possibly contain high levels of pesticides and other contaminants. Remember, in other countries, pesticides, like dioxins and DDT, are used with no governmental regulation or control. These potentially toxic chemicals can be sprayed on the herbs and plants in large amounts. If the plants used in a particular OTC compound are grown outside the United States, and most are, they could quite easily be contaminated with almost anything you could imagine. And no one is really testing to see what could be in these concoctions. It can be pretty worrisome from a personal safety and health viewpoint.

If you choose to use any of these OTC preparations, I urge you to notify your physician that you are taking whatever it is. It would be very helpful to bring in your bottle as well. On it, the doctor can review the listed ingredients. The doctor can assess if there are any possible interactions or problems with any medicine they are prescribing for you. Further, by doing a physical examination and obtaining a blood sample, the doctor can determine if the OTC compound is having any effect on your blood pressure, pulse, or lab functions. I cannot emphasize this point enough: make sure your doctor knows everything - including any vitamins - you take on a regular basis.

Also, make sure you assess the claims of some of the products available over the counter and, increasingly, over the Internet. There are several catch words that marketers use that should immediately perk up your ears for increasing scrutiny. I ran across this site which has too wonderful claims. One, the product helps you sleep better and, two, it "makes" you lose weight while you sleep. Further, it apparently decreases body fat, again, while you sleep. Now, if there were actual scientific information that this product or its ingredients truly did these miraculous things, don't you think it would be the hottest news topic ever? I certainly think so. But, since with these "nutritional supplements" no one has to actually prove anything, the company can say pretty much anything they want. Also, beware of products sold primarily with "testimonials." These could come from company employees or nonexistent people. Who would know? The FDA has a great deal of excellent consumer information on what to look for in OTC product claims and the FDA states, wisely, "if a product's claim sounds too good to be true, it probably is." Losing weight, actually reducing specifically body fat, while you sleep just sounds entirely too good to be true. At least it does to me.

Another site on the 'Net really gave me chills. This site, whose ad showed up in my spam folder, either has a really bad proofreader or purposely spelled the names of its products to sound like the names of approved prescription drugs for weight loss. It's products were listed as "Phentirimine," "Tennuate," and "Ionimine," apparently takeoffs of the prescription medicines Phentermine, Tenuate (diethylpropion), and Ionamine (a brand-name of phentermine). In closer examination of their listing, it is easy to see that these herbal products have absolutely nothing to do with the prescription medicine they, in my opinion, sttempt to mimic. They contain, basically, bitter orange, guarana, and chromium picolinate. The fact that these are unproven herbal compounds that are not approved by the FDA for anything doesn't bother me as much as the apparent attempt at deception. By listing these products with names as close to the "real" pharmaceuticals as they can be without being sued for copyright infringement, they - again, in my opinion - are trying to deceive consumers into believing they are getting the real drugs at a lower price and without a prescription. That's just plain wrong. And their effects could possibly be detrimental to your health if taken in an improper dosage or in combination with other medications, especially if you have underlying medical problems. By the way, the same web site - and many others I have found in my wanderings - offer "weight loss patches" that contain the magical ingredient...are you ready? Sea kelp! Again, the names for the patches even ring of prescription medications - Adipatch, Bontripatch, and Phenterpatch. All contain the same ingredient (sea kelp) but in varying "dosages." The Internet is a scary place for consumers, especially desperate consumers looking for help for very real problems. Please read everything you see online very carefully and don't make quick decisions. Better still, ask your doctor for advice and bring a printout of the product claims and ingredients. Dont be deceived!

The FDA has published a statement about OTC weight loss products that basically says caveat emptor ( "buyer beware)." They also have an excellent site for information on weight loss and fitness. For an excellent review of dietary supplements and possible drug interactions, check out this article from the American Council on Science and Health.

Postscript (March 30, 2005): MSNBC recently ran an excellent article on the downright garbage you are buying off the Internet and the dangers these cloned "miracle drugs" may pose to your health. It is well worth the reading.

Postscript (April 19, 2005): WebMD, which is a great site for health education and consumer health information on almost any topic, had a great article today on the "Top 5 Diet Scams" - fascinating reading!

Postscript (April 26, 2005): Weight loss herbal remedies run risk of thyroid disorders

Postscript (October 4, 2005): There is an excellent discussion about new TV advertisements here.

Postscript (October 18, 2005): The FTC has launched a comprehensive investigation into diet advertising fraud

1. Saper, RB, Eisenberg DM, Phillips RS; Common Dietary Supplements for Weight Loss; American Family Physician 70(9):1731-8 (November 1, 2004)
2. Kovacs, EM, Lejeune MP, Nijs I, et al. Effects of grean tea on weight maintenance after body-weight loss; British Journal of Nutrition 91(3):431-7 (March, 2004)
3. Mhurchu CN, Poppitt SD, McGill AT, Leahy FE, Bennett DA, Lin RB, Ormrod D, Ward L, Strik C, Rodgers A. The effect of the dietary supplement, Chitosan, on body weight: a randomised controlled trial in 250 overweight and obese adults. Int J Obes Relat Metab Disord. 2004 Sep;28(9):1149-56.

Copyright © 2005

Albright Bariatric Clinic