On January 4, 2007, the Federal Trade Commission fined the marketers of four over-the-counter, non-prescription diet pills a combined $25 million for making false advertising claims, ranging from rapid weight loss to reducing the risk of cancer. The companies have to stop making these claims, which the FTC says are not backed by scientific studies. However, the FTC said these products would remain on store shelves.

Some of the diet pills have marketed their claims via infomercials (Cortislim) and celebrity endorsements (TrimSpa, Anna Nicole Smith). The FTC also said that customers using the products and providing testimonials were paid as much as $20,000 for their “endorsements.”

Fines were slapped against marketers of: Xenadrine EFX, One A Day Weight Smart, Cortislim and TrimSpa. FTC Chairman Deborah Platt Majoras said that some of the funds paid as civil fines would be returned to consumers.

The largest fine was levied against two marketers of Xenadrine EFX, made by Nutraquest Inc. (formerly known as Cytodyne Technologies) The marketers will pay at least $8 million and as much as $12.8 million. A federal lawsuit has been filed in Newark, NJ. A $12 million fine was also levied against seven marketers (Window Rock Enterprises) of CortiSlim and CortiStress. The Bayer Corp. of Morristown, NJ will pay a $3.2 million civil penalty to settle the claims. TrimSpa (Whippany, NJ) will pay $1.5 million.

In addition, the FTC took action several years ago to fine Enforma Natural Products Inc. $10 million for making unsubstantiated claims about its OTC/mail order diet products advertised in its infomercial airing on TV. This was the largest such fine in FTC history.

Every woman’s magazine is filled with full-page, splashy ads for these products for a long time. And, substantial sales are racked up by their infomercials. Apparently, the FTC does this type of action every once in a while, targeting the more popular brands made by companies that are easy to identify and locate. They do this to flex their muscle, make an example, and “scare” the other companies into reforming their marketing practices voluntarily.

Hopefully, the dozens of other diet pill makers will clean up their act, but maybe not. Maybe they’ll continue making these claims until the FTC fines them too. We feel that, to have any real teeth in this action, the manufacturers should have been required to remove existing stock from store shelves, and many more companies and brands should have been fined.

In the weight loss market, the more things change, the more they stay the same. This “war” between the FTC and OTC appetite suppressant manufacturers has been going on as long as we have been tracking the market—since the late 1980s.

The media and women’s magazine have been “urged” to refuse or remove these type of ads from their magazines, or investigate the claims being made. Has that happened? Of course not, because the magazine publishers need and want the diet pill advertising revenues.

What About Hoodia?

Hoodia Gordonii, the African plant extract that's supposed to suppress your appetite and is flying off the shelves in drugstores and Internet websites, has been getting lots of attention lately. But doctors who treat obesity claim that there is only the slimmest of evidence that this diet supplement works. Even if it does, many of the pills on sale now may contain little or none of the active ingredient. Bottles of Hoodia with 60 to 90 pills usually sell for $20-40 each.

So far, there have been no data on human testing published in reputable medical journals on Hoodia. Even unpublished data are inconclusive or based on very short time periods. Since all nutritional supplements are very loosely regulated by the FDA, there are NO guarantees that the bottles actually contain what the label claims. Unilever says that i tested at least 10 representative samples of supplements sold in the U.S. by other companies and none contained appreciable amounts of Hoodia. Obesity experts have no yet discovered and side effects from Hoodia, but say it hasn't been tested enough to be sure.

Want to waste your money on another "miracle" diet potion that's unproven?  That's up to you - it's YOUR money!

Conclusions: Our Position on OTC Diet Pills, Ephedra and Ephedra Replacement Ingredients…

Both the registered dietitian and psychologist that contributed to the development of BestDietForMe.com agree that we as a company cannot in good faith "recommend" these over-the-counter diet pills as a safe and viable or "legitimate" weight loss program. Consequently, the customers of our Web diet analysis service BestDietForMe.com will NOT receive any "matches" in their reports for OTC diet pills.

At this time, there is minimal scientific evidence to support the notion that any of the purported thermogenic ephedra-replacement products actually produce weight and/or fat loss. While several of the products have been shown in preliminary studies to contain thermogenic properties, none of the studies have shown actual, statistically significant weight and/or fat loss over time in a scientifically valid study of any length. Therefore, although citrus aurantium or green tea extract combined with caffeine, may boost one’s metabolic rate, we do not know whether this will lead to the desired outcome of weight and/or fat loss. What is known is that the use of any supplement alone, without change in diet and exercise behavior, will not lead to successful long-term weight loss.

In spite of the limited support for their safety and effectiveness, OTC appetite suppressants are used by a substantial number of do-it-yourself dieters as weight loss programs, both in America and internationally. For our company to simply ignore them as a weight loss method would be wrong and would be "hiding our heads in the sand." Hence, this report outlines the facts about these products and the ingredients they contain, and encourages the consumer to consult with his or her physician before ingesting any of them.

We present here a "status report" covering the nature of retail appetite suppressants, the major companies selling them under a wide variety of brand names (Metabolife, Xenadrine, Hydroxycut, Stacker 2, Ripped Fuel, Dexatrim Natural, etc.), how people use them as part of their weight loss programs, the side effects consumers have reported, government regulation/oversight, clinical studies analyzing them, and more.

Many dieters, looking for a quick weight loss method, ask: "What are the best diet pills?" That depends. Before examining individual products, you should be aware of several problems that, in our opinion, are attributed to many of the OTC diet pills sold now or in the past in the United States.

• Because these substances come under the heading of "supplements" instead of medications, they are not required to undergo rigorous FDA testing to ensure they are safe and do what their manufacturers claim they do. Hence, when you swallow one of these pills, you really do not know whether it is safe or effective.

• Some ingredients contained in OTC diet pills may be harmful and cause side effects (such as Ephedra when it was used), although the research is still controversial. Remember, these substances are not required to undergo rigorous evaluation such as with prescription diet drugs like Meridia, Xenical and Phentermine. Consequently, our knowledge of their effects is limited.

At best, these OTC diet pills will produce short-term weight loss, because they do stimulate or speed up one’s metabolism, and act as diuretics. Part of the their popularity stems from the fact that these are inexpensive weight loss aids. A package of 24 or 30 diuretic capsules usually retails for $4.99-6.99, and most weight loss dietary supplements cost about $15-20 per package, depending on the number of capsules (60, 90, 100). Some OTC diet pills can cost up to $39.99 for a bottle. Hydroxycut costs about $29.99, as does Ephedra-free Metabolife^®, while Stacker 2 costs $31.99 per bottle. Discounts can be had by ordering over the Web or via multi-level independent distributors.

History is littered with frightening tales of snake oil salesman peddling elixirs and tonics, most of them ineffective and many dangerous, to the public. In 1958 Congress attempted to curb this abuse by giving the FDA power to regulate supplements as it would food or drugs. But in 1994, the agency’s authority was revoked with the passage of the Dietary Supplement Health and Education Act, a piece of legislation co-sponsored by Senator Tom Harkin and Senator Orrin Hatch. The new law stipulated that makers of dietary supplements do NOT have to seek approval from the FDA and do not have to prove their products safe and effective.

Since 1982, there have been more than 50 different brands of appetite suppressants on the market. Prior to 1989, most were NOT liquid shakes, but in the form of supplements, tablets, gums, lozenges, candies, capsules, and pills. Like other health care categories, diet pills have experienced their share of controversy over the safety of some of their ingredients, particularly ephedra.

Many people don't use retail diet aids because of past negative publicity about ingredients like PPA (phenylpropanolamine). There have been cases of potentially fatal heart problems, kidney disease and muscle damage associated with the use of phenylpropanolamine-containing products. There have also been reports of amphetamine "speed"-like adverse reactions to PPA-containing products. These include accelerated pulse rate, tremor, restlessness, agitation, anxiety, dizziness and hallucinations. These reactions may be aggravated by the presence of caffeine in many of these products.

Marketers of these products are shrewd in the way they package and sell them. At first glance, the unsophisticated consumer would look at the store display and assume that each product is probably made by a different company. Not so. If one examines the fine print, one frequently finds that the same company sells several diet aids with different names, different price points, and slightly modified ingredients.

Obviously, ephedra has been under intense scrutiny by the government and medical community for some time now. Consequently, most all of the OTC weight loss supplement manufacturers have scrambled to bring to market ephedra free products, to protect their sales.

BestDietForMe.com analysts examined dozens of labels of the most commonly found OTC diet pills, at a local pharmacy/chain drug store. We wanted to see what herbs, vitamins, or other ingredients are now being used, once ephedrine (a stimulant) is omitted. Obviously, if one stimulant is taken out, then another has to be added (like caffeine and green tea extract) to speed up one’s metabolism and/or suppress the appetite, and result in weight loss. It appears that caffeine, hoodia gordonii (an herb) green tea extract, chromium, cellulose, garcinia cambogia, silica, stearic acid, and guarana extract are the most common ingredients now being used, in various combinations and dosages. In past years, PPA (phenylpropanolamine) was used heavily, but today virtually no one is using that anymore.

Caffeine seems to be the most common replacement for ephedra, in terms of a stimulant. However, consumers should ask themselves if they really want to ingest more caffeine on a daily basis (especially if they already drink coffee). The combined amounts of caffeine from diet pills and coffee could easily make one more nervous and jittery at the least. Moreover, the added stimulation from caffeine can trigger panic attacks in people prone to them, as well as cause caffeine overdoses that may result in trips to the emergency room.

Other ingredients: Things like cellulose are ingredients used to make you feel full (fiber) and suppress your appetite. Other ingredients are herbs, which, when combined with other herbs and non-herb substances, may act in ways unknown and with potential side effects. In addition, anything called an "extract" is not a natural substance—it’s chemically processed in some way.

Following are a few examples of commonly found retail diet pill brands and their main ingredients:

Starch Blocker… cellulose gum, soy/lecithin, sodium citrate, magnesium stearate, other ingredients.

Ripped Fuel… caffeine, green tea extract, guarana seed extract, white willow bark extract, L-tyrosine, cellulose, magnesium stearate, other ingredients.

Diet Fuel… St. John’s Wort extract, green tea extract, ginger root, citrus aurantium fruit extract, other ingredients.

Metabolife^® (ephedra-free)… calcium, copper, chromium, sodium, potassium, garcinia cambogia, green tea extract, guarana extract, caffeine, stearic acid, modified cellulose, sodium citrate, lecithin, other ingredients.

Dexatrim Natural… calcium, chromium, green tea extract, ginseng root, dicalcium phosphate, stearic acid, silica, propylene glycol, other ingredients.

Hydroxycut… calcium, chromium, green tea extract, potassium, garcinia cambogia, alpha lipoic acid, caffeine, silica, guarana extract, cellulose, magnesium stearate, other ingredients.

Stacker 2… kola nut, citrus aurantium, white willow bark, caffeine (200 mg), gelatin, green tea (leaves), gelatin, dextrose, magnesium stearate, other ingredients.

Other ingredients found in diet pills:

One of the most popular pills to come along in recent years was something called a starch blocker. Manufacturers claimed that the pills blocked the body from absorbing starches. When the FDA banned these pills, the manufacturers argued that since they were made from kidney beans, they should be classified as a food, rather than a drug. The FDA disagreed, however, and has been backed by the courts.

In past years, PPA used to be the leading over-the-counter diet aid ingredient, appearing in most of the OTC diet pills on the market. Brands such as CONTROL, DEXATRIM, DIETAC, PERMATHENE, PROLAMINE, APPEDRINE, and THINZ-SPAN, have all appeared on drug store shelves at one time, although some may no longer be on the market. They all contained PPA. It is common practice in this market to re-introduce basically the same product several years later, under a different brand name. Today’s appetite suppressants have been reformulated to take out the PPA.

No well-controlled study has shown that PPA is effective as an aid in long-term weight control. It may help one lose weight for a few days, but the person gains the pounds back when he/she stops taking them. And it does not help the person make the changes in diet and exercise patterns which are needed to keep weight off.

Not only are there significant questions of PPA's effectiveness, but there are also serious doubts about its safety. PPA can cause hypertension (high blood pressure), even in young, healthy adults given amounts within the recommended dosage. The FDA acknowledges that PPA is hazardous to a significant portion of the population (at least 20%).

Regarding Ephedra, and Ephedra-replacement ingredients, is it just our company that doesn’t like this substance? Not so.

In 2003, the FDA officially banned the herbal weight loss treatment/dietary supplement ephedra. The FDA has already alerted 62 companies that sell supplements containing ephedra, and consumers have been warned to stop taking the product. Most of the large dietary supplement manufacturers and retailers had already shifted away from ephedra products before the FDA ban.

Consumer Reports in May 2001 called ephedra’s effectiveness "sketchy at best" and said that concerns about safety are numerous. In Sept. 2001, Ralph Nader’s Public Citizen Health Research Group called for a federal ban on the sales and production of ephedrine alkaloid dietary supplements.

Other criticisms include poor and inconsistent product quality.

Even industry associations admit that people may be taking too much of ephedra-based products, or taking them when they should not, due to pre-existing health problems. Therein lies the inherent problems with any "do-it-yourself" weight loss products, be they OTC diet pills, meal replacements, or other—there is absolutely no control over how they are used by the dieter.