Does it Work? - Cortislim Warned By The FDA

We've discussed Cortislim here before so I thought I'd pass along a copy of a Warning Letter recently sent from the FDA to Cortislim's manufacturer, Window Rock Enterprises. The FDA states that none of Cortislim's claims are "supported by reliable scientific evidence":

Department of Health and Human Services Public Health Service
Food and Drug Administration
Los Angeles District
Pacific Region
19701 Fairchild
Irvine, CA 92612-2506


WARNING LETTER

August 19, 2004

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Stephen Cheng, President
Window Rock Enterprises, Inc.
601 Valencia Ave., Suite 150
Brea, CA 92823

W/L 44-04

Dear Mr. Cheng:

The U.S. Food and Drug Administration (FDA) conducted an inspection of your firm, Window Rock Enterprises, Inc., located at 601 Valencia Avenue, Suite 150, Brea, CA 92823, on April 5th and April 7th, 2004. During this inspection, you provided our investigator with the following promotional materials for your product CortiSlim, which are shipped to customers with the product:

CortiSlim Brochure
CortiSlim Information Sheet (includes supplement facts, ingredients, and directions for use)
Cortisol Stress Test
CortiSlim Instant Savings and Money Back Guarantee Certificate
CortiSlim Quick Start Guide
Our investigator also collected information, including copies of scientific research and studies, you provided to substantiate the claims made for your product CortiSlim. In addition, after our inspection of your firm, we reviewed labeling for CortiSlim on your website at http://www.cortislim.com.

VIOLATIONS

A review of your labeling for CortiSlim, including the promotional materials listed above, indicates serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) (21 U.S.C. 321 et seq.). Specifically, we have determined that your CortiSlim product is misbranded under sections 403(r)(6)(B) and 403(a)(1) of the Act (21 U.S.C. 343(r)(6)(B); 343(a)(1)) because the product’s labeling includes unsubstantiated claims. Under the Act, as amended by the Dietary Supplement Health and Education Act, dietary supplements may be legally marketed with claims to affect the structure or function of the body (structure/function claims), if certain requirements are met (21 U.S.C. 343(r)(6); 21 C.F.R. 101.93(g)). The manufacturer of a dietary supplement containing a “structure/function” claim in the product’s labeling must have substantiation that the claim is truthful and not misleading (see 21 U.S.C. 343(r)(6)(B)). You can find the Act and FDA regulations on the Internet through links on FDA’s web page: www.fda.gov.

Examples of some of the structure/function claims made in the labeling for your CortiSlim product include:

CortiSlim Product Label: “Eliminate Cravings,” “Controls Appetite”
CortiSlim Brochure: “Ease ‘stress eating,“’ “Suppresses appetite,” “Burn calories more efficiently and naturally through thermogenesis,” "Controls cortisol levels within a healthy range, ” “control appetite,” “reduce cravings”
CortiSlim Quick Start Guide: “curb appetite and cravings,” “weight loss solution”
CortiSlim Instant Savings and Money Back Guarantee Certificate: “lose weight,” “reduce cravings for carbohydrates and sweets, ” “take the edge off your appetite,” “enhance metabolism through thermogenesis”
Cortisol Stress Test: “cravings for sweets and carbohydrates will diminish”
Website:
Under “The SENSE Program,” Exercise topic section: “appetite control”
Under the “Ingredients” section: “controls cortisol levels within healthy range and help[s] you lose weight,” “control appetite,” “helps to reduce cravings”
Under the “FAQ (frequently asked questions)” section: “reduce cravings,” “Appetite and craving control,” “weight loss,” “control appetite”
Under the “User Guide” section: “curb appetite and cravings
We have reviewed these claims, along with the substantiation package you provided, and concluded that they are not supported by reliable scientific evidence. Because these claims lack substantiation, they are false or misleading, and cause your product to be misbranded within the meaning of section 403(a)(1) and 403(r)(6)(B) of the Act. It is a violation of section 301(a) of the Act (21 U.S.C. 331(a)) to introduce or deliver for introduction into interstate commerce any food, including a dietary supplement, that is misbranded.

This letter is not intended to provide an all-inclusive list of violations concerning your firm and its products. You are responsible for ensuring that all products marketed by your firm comply with applicable United States laws, including the Act and its implementing regulations.

We request that you take prompt action to correct these violations. Failure to promptly correct violations may result in enforcement action being initiated by FDA without further notice. The Act provides for seizure of illegal products and for an injunction against the manufacturer and/or distributor of illegal products.

You must notify this office, within fifteen (15) working days of the receipt of this letter, of the specific steps you have taken to correct the noted violations. Copies of the revised labeling for CortiSlim should also be submitted. If corrective action cannot be completed within 15 working days, state the reason(s) for delay and the time at which the corrections will be completed.

ADDITIONAL COMMENTS

During the April 2004 inspection, you provided our investigator with information to substantiate the following claims for CortiSlim:

“supports healthy cortisol levels”
“supports weight maintenance efforts”
Although these claims do not appear to be used in your current labeling for CortiSlim, we have reviewed them because they were referred to in your substantiation package. Based on the information provided in your substantiation package, we conclude that these claims are not supported by reliable scientific evidence. Unless you have additional information that would adequately substantiate these claims, any present or future use of such claims in the CortiSlim labeling would misbrand your product under sections 403(r)(6)(B) and 403(a)(1) of the Act.

Your written reply should be addressed to Compliance Officer John Stamp at the above address.

Sincerely,

/s/

Alonza E. Cruse
District Director

The FDA must not have been very impressed with Cortislim's much-touted "studies" on its web site. If you purchased Cortislim and want to try to get your money back under their 60 day guarantee, I'd suggest you do it NOW since an FDA letter like this one is often one step away from the company going out of business.

Thanks!! It's about time :)

Good deal, I hate seeing those commercials on tv. "We are concerned for you, now send us all your money" ;)

The FDA must not have been very impressed with Cortislim's much-touted "studies" on its web site. If you purchased Cortislim and want to try to get your money back under their 60 day guarantee, I'd suggest you do it NOW since an FDA letter like this one is often one step away from the company going out of business.

And while you're at it, make sure to file a chargeback with your bank (I'm assuming that most of the Cortislime buyers used a credit card to make their purchases).

WHY am I not surprised??? :devil:

Oh and of course, I'm sure that the Cortislime people have raked in millions of dollars - whatever fine(s) are slapped upon them by the FDA will only be a tiny dent in that. And "they'll be back" I'm sure, under another name, selling another phony, slimy diet product.

I have done some reading about the effects of elevated cortisol on weight gain. I have also tried losing weight with and without CortiSlim. The basis of any weight loss program, in my opinion, has to be a food program and some kind of physical activity program. Anything else is an add-on. That's what "supplement" means.

Although I agree that CortiSlim taken by itself will not result in much weight loss, I do find that CortiSlim helps with food cravings. That's just my experience. I also have done some checking of the herbs used in the product, and they all seem to be reliable herbal remedies. Reliable means that they have a history of use and effects that are well known to practitioners.

Of course, anyone who is against herbal medicine won't want to have anything to do with such products.

I am curious about where MrsJim got a copy of a supposedly official FDA letter to the company.

Jay
SW: 196
CW: 182
GW: 145

JayEll -- I posted the FDA warning letter, not MrsJim. It's on the FDA web site here: http://www.fda.gov/foi/warning_letters/g4945d.htm . The FDA's actions are matters of public record and they publicize letters like this to warn consumers about products and manufacturers that are violating federal law.

I have done some reading about the effects of elevated cortisol on weight gain. I have also tried losing weight with and without CortiSlim. The basis of any weight loss program, in my opinion, has to be a food program and some kind of physical activity program. Anything else is an add-on. That's what "supplement" means.

Of course, that's not how the company has been marketing CortiSlime - judging from the TV ads I've seen.

Although I agree that CortiSlim taken by itself will not result in much weight loss, I do find that CortiSlim helps with food cravings. That's just my experience. I also have done some checking of the herbs used in the product, and they all seem to be reliable herbal remedies. Reliable means that they have a history of use and effects that are well known to practitioners.

But ya know, I bet you can get the same ingredients generically for a lot cheaper than $50 a bottle, or even their 'sale' price of "buy four get 2 free!"[/quote]

Of course, anyone who is against herbal medicine won't want to have anything to do with such products.

I'm not against using 'herbals' at all. What I'm VEHEMENTLY against is the way that these scam artists overstate what these herbs can do, advertise them to desperate people (along with spurious, unpublished 'studies') as the latest miracle at a huge price, and basically RIP OFF people. CortiSlime is, unfortunately, only the latest in a long, LONG line of spurious 'diet miracles' and it won't be the last.

I'm sure that the folks behind "Window Rock Enterprises" have already started their plan to scam desperate dieters in 2005 by selling another crap diet pill under another name. Par for the course.

I am curious about where MrsJim got a copy of a supposedly official FDA letter to the company.


I see Meg already answered the query about the FDA letters...

And on a related note - an article by Dr. Stephen Barrett, M.D.

The entire article can be found here: http://www.quackwatch.org/01QuackeryRelatedTopics/PhonyAds/info.html

Be Wary of Health-Related Infomercials
Stephen Barrett, M.D.

Every day, dozens of health-related products are hawked through television infomercials, many of which bear superficial resemblance to a TV interview show. Over the years, I have seen ads for weight-loss plans, "cellulite" removers, exercise devices, hair-loss remedies, memory-enhancement programs, reading improvement systems, skin creams, and a myriad of dietary supplement products. Except for a few of the exercise devices (which may work if the user does not become bored with them), the vast majority of these promotions include false and misleading claims. The dietary supplement products are usually promoted with the types of claims we discuss in our article on Twenty-Five Ways to Spot Quacks and Vitamin Pushers. ( http://www.quackwatch.org/01QuackeryRelatedTopics/spotquack.html )

The Federal Trade Commission warns consumers to be aware that some television programs that look like talk shows are actually program-length commercials. One tipoff, says the FTC, is that the product promoted during "commercial breaks" is related to the program's content.

Don't make the mistake of thinking that anyone screens infomercials for accuracy before they are broadcast. Although the major networks maintain reasonable advertising standards, most cable broadcasters do not care at all whether their advertisers cheat their viewers. If they did, there would be few health-related infomercials.

Don't assume that products offering a money-back guarantee with honor them. If you must buy a product, do it with a credit card so that if you decide to seek a refund, you can ask the credit card to do a chargeback. Also be sure to record the name, address, and telephone number of the company so that if you are dissatisfied you will know where to complain. If a product you order does not arrive within 30 days after the charge appears on your credit card bill, you should assume that (a) the product will not come, or (b) the company is deliberately delaying so that by the time the product arrives, it will be too late to force a chargeback. If you want to return a product for a refund, keep your eye on the calendar. Most credit card companies limit the chargeback period to 60 days after the date on the bill. If you return a product for a refund, send a complaint to the credit company asking for a chargeback.

The best way to protect yourself from being misled by health-related infomercials is to ignore them. Since the percentage that are legitimate is close to zero, the likelihood of receiving valuable information is extremely small. Here are some recent examples that illustrate the deceptions. We have also posted an index of infomercials discussed on our sites or subjected to government regulatory action.

CortiSlim

CortiSlim is an alleged weight-loss product that contains vitamin C, calcium, chromium, "Cortiplex Blend" (magnolia bark extract, beta-sitosterol, theanine), "Leptiplex Blend" (green tea extract, bitter orange peel extract), and "Insutrol Blend" (banana leaf extract, vanadium). Its developer, Shawn Talbot, Ph.D, claims that by adjusting cortisol levels, CortiSlim removes a key physiological signal for weight gain and that the supplement also may help balance blood-sugar to reduce cravings and maximize metabolism to boost energy expenditure and fat-burning. During the program, a woman said she had been on CortiSlim for about three weeks and lost 14 pounds. It is not possible to do this. In August 2004, the FDA warned the manufacturer that claims such as "eliminates cravings," "controls appetite," enhances metabolism through thermogenesis," and "controls cortisol levels" were not supported by reliable scientific evidence and must be stopped.

If you require an appetite suppresant, there is always dexatrim for 7 bucks or so in the drug store, not that I use it. Also all those ingredients in cortislim can be bought cheaper by themselves although there is no proof that they are effective.

I admit that I have a problem with herbal products - or rather their marketers. I do know that there are some beneficial herbs, and have never disputed that. My problem is with the people that market them. Since these products are not regulated by the FDA, they can make any claims they want on them, and they obviously do. They don't have to prove it, unless they claim to cure a disease or make other medical claims. The government only gets involved in rare situations. Most manufacturers get around this by saying "This ingredient is thought to... believed to..." etc. But most consumers don't read it that way, they assume it is fact.

Many people think that if it says something on the label, it has to be true, or they would not be allowed to say so. This is 100% false, but most people don't know that. The laws that apply to drugs don't apply to herbal supplements. So, people believe the claims, no matter how outrageous they are.

Even the so-called "studies" that the supplement companies quote are almost always manipulated or fabricated.

Something else to consider is that these products don't have to contain the stated dosage in each capsule. They can tell you that each pill contains 1000 mg of XYZ but it can contain ZERO and it doesn't matter. Some even contain massively higher amounts than a stated dosage, which can be dangerous in many cases. You don't know what you are getting! They frequently use imported ingredients that are not subjected to rigorous standards and contain contaminants, such as lead.

Some reputable studies have shown promise and potential for a lot of herbs! However, they are usually handled in very clinical ways, with careful dosages and medical supervision. In nearly every case that I've read about, though, these dosages are more controlled and usually in much higher dosages than what you would ever get if you bought it in a health food store - assuming that you even know how much is in those little capsules, which you don't. At this point, you need medical supervision.

Many of these products cause side effects, or can be dangerous if you take certain medications, have allergies, etc. Look through this forum, at the many previous questions about weight loss products, and note how many times we've responded with studies that have shown serious problems. Yet you won't find any of this on the bottle. You can't sell many products that way.


For the record, Cortislim contains Bitter Orange which is a very dangerous supplement that will probably be banned by the FDA (though we know how long that takes). It's similar to ephedra. It's on the Consumer Reports Dirty Dozen list of most dangerous supplements. Cortislim doesn't tell you that. Cortislim also contains Chromium which has been proven NOT to affect weight loss. Period. Yet it's a good catch term for anyone trying to sell a quack weight loss product. Anytime I see a weight loss product that contains chromium, I immediately roll my eyes. Here we go again. Yes, I'm cynical, lol. Products like this are like a broken record, they reappear and reappear and reappear. Until the public becomes more educated and stops reaching for success in a bottle, and realizes that it's all about diet and exercise, then we'll see more products like this in the future. More innocent people will lose their hard earned money. More people will become ill. More quacks will get rich.

If appetite is a problem for anyone, then we highly suggest talking to your doctors about prescriptions. Products such as cortislim are a dangerous way to control your appetite. There are some very good medications out there. Medical supervision is always suggested :)

Meg, thank you for the information on the FDA letter. It's good to know that these things are out there for the public to see.

I certainly will be interested to see how the company making CortiSlim responds to this.

Jay

Hey all - I agree that a lot of these people are hocking products that simply don't work. BUT just because the FDA says something doesn't mean it's gospel. Come on people we all know they're in the pocket of the pharmetceutical companies. Many Asian Naturopathic doctors are very reliable & truthful about the natural means they use to treat & cure many diseases & personally I think that's the place to look if you're into natural medicine. They have the most detailed accounts of ancient medicine in the world. & look at their health, weight & lifespan compared to the western world. I'd a least give it a listen.
much love & health to all
Dawn

Hear, hear, DawnieBee! The FDA said Vioxx was OK, at least OK enough to release it on the unsuspecting public, and FDA has done this with a number of other pharmaceuticals in the past. The attacks on herbal-based supplements and alternative medicine are, in my humble opinion, a witch hunt with the drug companies behind it. That doesn't mean, however, that we don't need to use some sense and do some checking before deciding to try something. That's true with ANY drug or supplement.

Jay

My problem with herbal and "natural" remedies is that there is no control on it. If Vioxx was a herbal remedy, it'd probably stay on the market rather than be pulled off because of the lack of control. When some company decides to make some concotion and then say "lose weight fast with this!!!!", it makes me wary. I was prescribed a medication that was to help me lose weight, but I had an elevated blood pressure with it so the doctor took me off of it. There is no doctor supervision with weight loss medications that you can buy over the counter plus there is no proof that they work.

The other thing that annoys me is people who think "natural is better" or "natural is good for you" but there are natural/herbal drugs that can harm you or even kill you, my saying is "if you think natural is safe, try some hemlock" ;)

Good comparison! What we've learned from drugs that are pulled by the FDA is that long term studies and research can have surprising and unexpected results, even under the most careful conditions. The problem with herbal products is that they are not really being monitored. May supplement companies have strong records of hiding documents, and paying off complainants (via settlements) so that the public never finds out about their dangerous past. The studies that are done on drugs are very carefully monitored before they are available to the public, it's the effects later that cause them to be pulled. We don't have that luxury with herbal products. Time and time again, the only "studies" that are done are within the company and are highly biased. So-called "Independent Laboratories" are usually down the hall.

I think there is a lot of promise for a lot of herbs. However, they should be used, studied, and manufactured only under certain conditions, which guarantee their safety, and they must be forced to prove their claims. I'm sick to death of the false hopes they give people by their outright lies. There's no simpler way to put it. They lie.

I work in the blood/plasma industry. I have for 16 years. We are considered Phase 1 in drug manufaturing so I am very clear on the Code of Federal Regulations regarding drug manufacturing. We are closely monitored by FDA as well as other organizations.

I know enough about profit and the need for quality control and Good Manufacturing Processes to keep drugs safe. There is plenty of room for error that can lower the quality of medications all along the line, not just within the company that pours the powder in the capsule. I also know the dilemma many drug manufacturers would face in buying their supplies to make the drugs if they did not know anything about the plant in which they were purchasing this from unless they also were inspected by a common system. As an FDA regulated drug manufacturer, I am required to keep a paper trail of where any supplies came from that were used in the manufacturing process. We keep so much documentation that you would all be asleep if I wrote it all down. To sum it up, I was told by a co-worker when I was first hired, "If you pick your nose, you better initial for it."

I know the FDA is not perfect. They have a limited budget to operate on but the investigators I have worked with do the best they can. As for Vioxx, they can only clear the medications that they have seen clean research on. They cannot always tell what a drug will do after long term use. I've seen much hard work go up for review by the FDA, and it is no easy process. My company had one medication go for approval and we literally sent a vanload of research. It was sent back for 6 more months of research because there was one aspect of the documentation that was not clear.

Instead of criticizing the FDA for Vioxx being pulled, we should be grateful that they did find thousands of other drugs that DID show they were unsafe. They don't have a crystal ball, but they do have a strict manufacturing policy and for that I am thankful.

Instead of criticizing the FDA for Vioxx being pulled, we should be grateful that they did find thousands of other drugs that DID show they were unsafe. They don't have a crystal ball, but they do have a strict manufacturing policy and for that I am thankful.

Ditto !!

I am also in the research field of pharmaceutics. People just don't understand how difficult it is to get a successful drug, from the early stages of just finding the compound all the way to human trials. The only way to truly know the results of a drug is to take it through animal and clinical trials, but even then, you just never know until its on the market for a few years.

What scares me is the vitamin and herb industry, these are not regulated. Have you noticed that only recently they are putting expiration dates on vitamins....hmmmmm.

Vitamins-
In October of 1994, President Clinton signed into law the Dietary Supplement Health and Education Act (DSHEA).

The DSHEA was written to help empower American consumers to make choices about their own preventative healthcare strategies, and hopefully this would reduce the country's health care expenses.

Under the DSHEA it was decided that nutritional supplements would continue to be regulated as a food product rather than the more restrictive regulations that drugs fall under.

While this made multi vitamin and nutritional supplements widely available it also allowed nutritional supplement manufacturers to practically regulate themselves, since there was no agreed upon standard of good manufacturing practice and no government pressure to be true to the label on their products.

It was't until March of 2003, nine years after the DSHEA became law, that the FDA proposed new regulations to require current good manufacturing practices (CGMPs) in the manufacturing, packing, and holding of multi vitamin and dietary supplements.


But thats JMHO ;)

Thanks for posting the letter, Meg!

Hey all - I agree that a lot of these people are hocking products that simply don't work. BUT just because the FDA says something doesn't mean it's gospel. Come on people we all know they're in the pocket of the pharmetceutical companies. Many Asian Naturopathic doctors are very reliable & truthful about the natural means they use to treat & cure many diseases & personally I think that's the place to look if you're into natural medicine. They have the most detailed accounts of ancient medicine in the world. & look at their health, weight & lifespan compared to the western world. I'd a least give it a listen.
much love & health to all
Dawn
Just as I'm sure there are many naturopathic practitioners who are reliable and truthful about their treatments and results, there are also many who, just like the companies who manufacture and peddle Cortislim, Anorex, and all the other 'miracle' supplements that have come and gone, exaggerate and downright LIE about the effectiveness and results of their treatments...I see their ads in the 'free' newspapers all the time, with 'guarantees' of cures for obesity, cancer, hair loss, etc.

As far as comparing the health of Asian countries to that of the Western world - I'm inclined to say that MOST of that is due to lifestyle - i.e. diet and exercise - until recently the majority of the population in Asia lived in rural areas, mostly with no automobiles and raising much of their own food - vegetables, grains, lean meat, fish and poultry with very little sugar. However, this is now changing for much of the population as they become more 'civilized' and accustomed to driving or taking public transportation and eating fatty, sugary fast food. In fact, last year one of my coworkers went to China on a three-week tour - commented that especially in Taiwan and Bejing she saw quite a few overweight/obese people, especially children - however in the rural areas it was quite different, although they are rapidly becoming more 'civilized' there as well.

And of course, it's been shown in numerous studies that once many Asians emigrate to the US, they start becoming much less active and eat a LOT more calories, more sugar, fat, etc. and become overweight and/or obese as a result...

I can't speak for Asian immigration, but my husband is from Holland and when he moved here, he started gaining weight and becoming a couch potato. Where we live, he can't walk to the grocery store, or to any other shopping for that matter. He walked and rode a bike on a daily basis in Holland, and here he goes from the house to the car. Restaurant visits are much more uncommon there, and they have much less additives in the foods. He thought all American bread was sweet and was overwhelmed by the size of the grocery stores and the large portions in restaurants in the US. Free refills also don't happen in Europe, so they don't drink 48 ounces of Pepsi with each meal. It all adds up.