FTC Issues Warning Letter To Dr. Weil for H1N1 Products
Tsk, tsk, how dare Dr. Weil promote natural treatments for H1N1 instead of vaccination? He's been issued a warning letter by the FTC.
HERE to see the warning letter.
Weil Lifestyle LLC 10/15/09
UNITED STATES OF AMERICA
FEDERAL TRADE COMMISSION
BUREAU OF CONSUMER PROTECTION
WASHINGTON, D.C. 20580 DEPARTMENT OF HEALTH
AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
WASHINGTON, D.C. 20740
TO: [email protected]
www.drweil.com
FROM: The Food and Drug Administration and the Federal Trade Commission
RE: Unapproved/Uncleared/Unauthorized Products Related to the H1N1 Flu Virus; and
Notice of Potential Illegal Marketing of Products to Prevent, Treat or Cure the H1N1 Virus
DATE: October 15, 2009
WARNING LETTER
This is to advise you that the United States Food and Drug Administration ("FDA") and the United States Federal Trade Commission ("FTC") reviewed your website at the Internet address www.drweil.com on October 13, 2009. The FDA has determined that your website offers a product for sale that is intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus in people. This product has not been approved, cleared, or otherwise authorized by FDA for use in the diagnosis, mitigation, prevention, treatment, or cure of the H1N1 Flu Virus.
In addition, FTC staff reminds you that the FTC Act, 15 U.S.C. § 41 et seq., requires that claims that a dietary supplement can prevent, treat, or cure human infection with the H1N1 virus, must be supported by well-controlled human clinical studies at the time the claims are made. More generally, it is against the law to make or exaggerate health claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims. Violations of the FTC Act may result in legal action in the form of a Federal District Court injunction or Administrative Order. An order also may require that you pay back money to consumers.
Some examples of the claims on your website include:
On a webpage entitled, "The Swine Flu - H1N1 ," with the subtitle "Swine Flu and You":
"[D]uring the flu season, I suggest taking a daily antioxidant, multivitamin-mineral supplement, as well as astragalus, a well-known immune-boosting herb that can help ward off colds and flu. You might also consider. .. the Weil Immune Support Formula[,] which contains both astragalus and immune-supportive polypore mushrooms ...."
On a product webpage describing the Immune Support Formula:
"The Immune Support Formula contains astragalus. . . . Astragalus ... is used traditionally to ward off colds and flu and has been well studied for its antiviral and immunity-enhancing properties."
"Th[e] synergistic combination of immune modulators [found in the Immune Support Formula] is especially useful for those who tend to get every bug that goes around during the winter."
On the same webpage, under "Supplement Facts," describing the Astragalus supplement (which is one element of the Immune Support Formula):
"Astragalus ... is ... used traditionally to ward off colds and flu, and has demonstrated both antiviral and immune-boosting effects in scientific investigation."
On the website's home page, DrWeil.com:
"Worried About Flu? Dr. Weil's Immune Support Formula can help maintain a strong defense against the flu. It contains astragalus, a traditional herb that boosts immunity. Buy it now in one click, and start protecting your immune system against flu this season."
On the Dr. Weil Vitamins - Daily Vitamin Packs webpage:
"[L]earn more about Dr. Weil's Immune Support Formula, which contains astragalus - an herb Dr. Weil recommends to help ward off colds and flu."
The Secretary of Health and Human Services, under section 319 of the Public Health Service Act, 42 U.S.C. § 247d, has determined that a public health emergency exists nationwide involving the H1N1 Flu Virus that affects or has the significant potential to affect national security. Following this determination and in response to requests from the U.S. Centers for Disease Control and Prevention, FDA issued letters authorizing the emergency use of certain unapproved and uncleared products or unapproved or uncleared uses of approved or cleared products, provided certain criteria are met, under 21 U.S.C. § 360bbb-3. The marketing and sale of unapproved or uncleared H1N1 Flu Virus-related products that are not authorized by and used in accordance with the conditions of an Emergency Use Authorization, is a potentially significant threat to the public health. Therefore, FDA is taking urgent measures to protect consumers from products that, without approval or authorization by FDA, claim to diagnose, mitigate, prevent, treat or cure H1N1 Flu Virus in people.
You should take immediate action to ensure that your firm is .not marketing, and does not market in the future, products intended to diagnose, mitigate, prevent, treat or cure the H1N1 Flu Virus that have not been approved, cleared, or authorized by the FDA. The above is not meant to be an all-inclusive list of violations. It is your responsibility to ensure that the products you market are in compliance with the FFDC Act and FDA's implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that the claims you make for your products do not adulterate or misbrand the products in violation of the FFDC Act. 21 U.S.C. §§ 331, 351, 352. Within 48 hours, please send an email to [email protected], describing the actions that you have taken or plan to take to address your firm's violations. If your firm fails to take corrective action immediately, FDA may take enforcement action, such as seizure or injunction for violations of the FFDC Act without further notice. Firms that fail to take corrective action may also be referred to FDA's Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws.
FDA is advising consumers not to purchase or use H1N1 Flu Virus-related products offered for sale that have not been approved, cleared, or authorized by FDA. Your firm will be added to a published list on FDA's website of firms and websites that have received warning letters from FDA concerning marketing unapproved, uncleared and unauthorized H1N1 Flu Virus-related products in violation of the FFDC Act. This list can be found at www.accessdata.fda.gov/scripts/h1n1flu. Once the violative claims and/or products have been removed from your website, and these corrective actions have been confirmed by the FDA, the published list will be' updated to indicate that your firm has taken appropriate corrective action.
If you are not located in the United States, please note that unapproved, uncleared, or unauthorized products intended to diagnose, mitigate, prevent, treat, or cure the H1N1 Flu Virus offered for importation into the United States are subject to detention and refusal of admission. We will advise the appropriate regulatory or law enforcement officials in the country from which you operate that FDA considers your product listed above to be an unapproved, uncleared, or unauthorized product that cannot be legally sold to consumers in the United States.
Please direct any inquiries to FDA at [email protected] or by contacting Kathleen Lewis at 301-436-2148.
It is also your responsibility to ensure that the products you market are in compliance with the FTC Act. FTC staff strongly urge you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence. The FTC also asks that you notify it via electronic mail at [email protected] within 48 hours of the specific actions you have taken to address the agency's concerns. If you have any questions regarding compliance with the FTC Act, please contact Karen Jagielski at 202-326-2509.
Very truly yours,
/S/
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission
/S/
Roberta F. Wagner
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
The FDA says it needs scientific proof before anyone can sell, or promote any product that SAYS IT CAN CURE OR PREVENT ANY FLU.
I would like to see the scientific proof that a flu vaccine has ever been proven to prevent any flu and or to help to cure any type of flu. Show me.
I would like to see the number of people who have side effects or die from taking this H1N1 vaccine after it is all over and done.
And compare this with the number from the time before the government started yearly flu vaccines.
Posted by: Michael McKinney | October 29, 2009 at 11:40 AM
Condensed History of Herbal Pharmacy,"Snake Oils", and the Pharmaceutical Industry
For hundreds of years the European Pharmacopoeias collected and categorized information from research and reported responses of natural herbal remedies as this was the medicines prescribed by the doctors. During this time extensive research was also categorized regarding Homeopathic medicines which were also widely prescribed by European doctors. In America, as the missionaries moved west to establish their church missions, they collected information from the Indians who already had figured out which herbs did what as they had been utilizing the natural plants for thousands of years and passed on their knowledge through their Medicine Men. The pharmaceutical industry paid these missionaries to collect the plants and send these herbal remedies to them, and the missionaries used this money as an additional means of funding their religious work. There were not many toxic manmade drugs during the 1800's, except for the highly addictive cocaine and heroin "medicines" such as "Laudanum" which were guaranteed to be "safe" and widely prescribed until finally Congress put a stop to this highly lucrative business in favor of preventing further widespread addiction to the American public. Later Congress passed a law which then prevented the pharmaceutical industry from patent protection on natural herbal remedies which they confirmed as "God given in the natural domain" and therefore open to all in the "public domain". Subsequently the Pharmaceutical Industry began to develop more and more manufactured chemical concoctions for the purpose of patent protection and Big Bucks.
Consequently this chemical drug industry began an earnest campaign to discredit the very same herbal medicines that they had previously distributed themselves by falsely claiming them as "ineffective" and "dangerous". They converted a phrase that previously had a positive meaning, "Snake oils" into a negative concept in order to create the impression that these were a "waste of money based on Old Wives Tales". For the people living during the time of this transition, this was confusing because "Snake Oils" were indeed a legitimate and proven effective treatment for snake bites, primarily the Melaleuca (Tea Tree) essential oils which were imported here all the way from Australia for this purpose. "Snake Oil Salesmen" made a good living during the pioneer days because this was indeed an effective treatment and the people in the West relied upon these medicine salesmen for Snake Oil as well as many other natural remedies. The legitimate Snake Oil salesmen had lots of repeat business because these medicines ACTUALLY WORKED. Of course fraudulent medicine salesmen figured out that they could move from town to town selling colored sugar water "medicines" and they were hard to catch up with by the time the customers figured out that they had spent their hard earned money on fake remedies. These con artists unintentionally assisted the newly developing manmade drug business by further giving genuine snake oil salesmen a bad name.
Today we have a century of organized indoctrination and propaganda from the Pharmaceutical Industry resulting in medical doctors who are brainwashed from medical school onward. They do not receive the training that Naturopathic and Homeopathic doctors receive regarding nutritional and herbal therapies, and they are not aware of the extensive research and science which supports these proven therapies, many of which were used by our ancestors although their doctor's prescriptions were based primarily on "anecdotal" evidence. Example: When the doctors continually reported that Melaleuca oil recovered their patients from rattlesnake bites, this was considered to be Valid Scientific Evidence. [Basically this is what I call the "Proof in Pudding Test"] In spite of the fact that today we have accumulated Scientific Evidence that confirms the Anecdotal Evidence of these natural therapies which were already being utilized in the world of natural medicine for hundreds to thousands of years, the only "evidence" that is recognized by the conventional medical system today is their own industry funded drug trials and studies. [I will refrain from further discussing the fraud and
manipulated "results"]
Big Pharma has succeeded in their century long political efforts to obtain the cooperation of the AMA, FDA, and all medical and government organizations with the end result being a MONOPOLY, although technically this is illegal. However, since the American conventional medical system is entirely under the control of the Pharmaceutical Industry we can never expect the "expert opinions" of medical doctors who are only trained in drugs, to guide us towards true healing.....Instead is it our own responsibility to educate ourselves in order to pursue nutrition, herbs, essential oils and other natural therapies that ACTUALLY WORK.
Robert Frost said it best when he wrote this in 1920:
"I shall be telling this with a sigh
Somewhere ages and ages hence:
Two roads diverged in a wood, and I--
I took the one less traveled by,
And that has made all the difference."
Posted by: Autism Grandma | October 24, 2009 at 12:32 AM
Theresa:
Thanks for correcting me on FDA/FTC.
But if I may, you're mis-quoting your source re the cost of clinical trials. The source you cite says that's how much drug companies spend on a drug, not on the trials.
And my question remains: putting Weil aside, how should government agencies (whose job it is to protect the public) do their job? Should any-and-all health claims be permitted? If it's not going to be "anything goes," then presumably companies like Weil's need to back up their claims.
Not that it's clearly not enough that "there is some evidence." It has to be good evidence, and the *balance* of evidence (including both positive and negative results) should point to a product's effectiveness.
Regards,
Chris.
Posted by: Chris MacDonald | October 21, 2009 at 12:11 PM
THIS IS REALLY IMPORTANT INFORMATION ABOUT THE GOVERNMENT RESTRICTING FREEDOM OF INFORMATION, AND CONFLICT OF INTEREST IN THE CDC.
ALERT: Special Swine Flu Update http://articles.mercola.com/sites/articles/archive/2009/10/21/Special-Swine-Flu-Update.aspx
Source: articles.mercola.com
Urgent and vital information you need to know about the massive amount of disinformation that the media has recently escalated as best demonstrated by 60 Minutes segment on Swine Flu which aired this past Sunday.
Pat Robinson
Posted by: Pat Robinson | October 21, 2009 at 09:45 AM
Hey, Chris MacDonald, I see your point about consumer protection. However, Dr. Weil's statements don't actually make claims that his products provide a specific protection against H1N1. What he says is that the ingredients in his products (like astralagus root) have been "used traditionally to ward off colds and flu" and have "demonstrated both antiviral and immune-boosting effects." Now, those statements are true. Astralagus, echinacea, etc., have been used traditionally to ward off colds and flu. Even the University of Maryland, which thinks that women who suffer adverse effects from vaccines are making it up, acknowledges here (http://www.umm.edu/altmed/articles/astragalus-000223.htm) that "studies have shown that astragalus has antiviral properties and stimulates the immune system, suggesting that it is indeed effective at preventing colds."
So now that you see that Dr. Weil's claims are backed up by real research, you can see the problem. The FTD (not the FDA, by the way) is basically saying that he can't market his formulations as anti-viral remedies unless he goes through the whole exercise of clinical trials. Now, since these remedies are traditional, I don't think he can patent them, so he could not possibly make any money if he had to go through the expense of clinical trials. Heck, he couldn't afford to make the product. Clinical trials cost "between $100 and $800 million per drug candidate" (http://www.dddmag.com/the-cost-of-clinical-trials.aspx)
So that's what the FTC has done: made it impossible for anyone to market a product as preventative or curative unless that product is a pharmaceutical (drug) that is synthetically produced and patentable. That's why homeopathic remedies all say on the package that they are not intended to prevent or cure any disease.
Posted by: Theresa | October 20, 2009 at 09:35 PM
Well before the pharmaceutical giants began dominating the medical profession, people actually knew a thing or two about healing. Granted the importance of good hygiene and the germ theory were not well understood then, but the healing properties of herbs and plants were known to many and that knowledge was passed down from generation to generation. There are studies showing herbs like astragalus, echinacea, elderberry etc do actually support or enhance immune function. Can you imagine how many less cases of the flu we'd have this year if in addition to telling people to wash their hands (and take the vaccine), these "health" agencies actually informed people about effective ways to support the immune system? By improving ones nutrition (certain herbs, vitamins and consuming whole foods especially ones loaded with antioxidants), managing stress and decreasing toxic exposure, we can improve our health and lessen the chances of getting sick. We all have a right to investigate and choose our path to wellness and it is not always the route big pharma, hospitals, NIH, CDC, the FDA, IACC etc. would have us take.
Posted by: Maureen H. McDonnell, RN | October 20, 2009 at 05:36 PM
So, should people just be allowed to sell whatever they want, and make whatever claims they want, without having to back up those claims?
This is a serious question of consumer protection. Weil should have to live up to the same standards of proof as anyone else does who claims to be able to cure or prevent disease.
If the FDA is wrong in enforcing this law, would someone please explain to me how any consumer is supposed to tell the difference between Dr. Weil's product and something really useless? And the answer can't be "Try it, and see if you don't get H1N1."
Posted by: Chris MacDonald | October 20, 2009 at 02:09 PM
The fact that credible voices in the medical field are being reprimanded by the government for suggesting there are natural ways to boost the immune system is incredibly frightening. The propaganda promoting the vaccine and Tamiflu as our only recourse for dealing with H1N1 is steeped in ignorance and obviously driven by profit motives. He may not see the light yet regarding vaccines and autism, but I hope Dr. Weil has the guts to fire back and stand up for our right to choose effective, safe and natural methods for keeping ourselves and our kids healthy!
Posted by: Maureen H. McDonnell, RN | October 20, 2009 at 09:58 AM
I think I just puked in my mouth...plandemic...yep...and the plan is this...make sure you put the autism parents fears down, make sure your perception of high and mighty is still in place, and oh, be sure, that the natural market claims are bogus because we said so. While we are at it, let's make sure all the major media markets don't tell one story of vaccine injury and create as according to CDC's powerpoint, a hysterical nation who fears that their next to die and will be begging for a vaccine. Don't look at the bombs going off in the tower...just look at the entire whole...just so tragic when that happens...don't look at the fine details, how vaccines like this are never tested as safe, and are full of toxic ingreidients, but then say, it's not toxic...and, make sure that high minded officials reinterate how herd immunity is a social responsibility. Make sure that you don't say preconditions killed them...and oh, make sure that you don't mention they recently got vaccinated....and or took some lovely tylenol or some other glutathione loss supplement. I guess it's rough if you can't patten a food, or an herb...because GOD made it? (BIG CLUE THERE)...damn those patten's....and their "rules"....
Posted by: Kathy Blanco | October 20, 2009 at 09:42 AM
Give me a break! Dr. Weil is one of the strong voices in a world of bullshit when it comes to medicine. I'm a believer in Dr. Weil (I take his vitamin products) and his practices although I disagree with his stand on vaccines. We need more people in the medical community that don't prescribe a drug for everything that ails us.
StagDad
Posted by: StagDad | October 20, 2009 at 08:02 AM
http://www.ageofautism.com/2009/09/uks-nhs-report-suggests-autism-increase-due-to-oversight.html
Age of Autism WARNING! WARNING! WARNING!
Posted by: Robin Rowlands | October 20, 2009 at 05:24 AM
FDA is making an example of Dr. Weil because he has such a large following.
But he's not exactly a radical voice in the world of alternative medicine. In fact, he shuns that term, preferring "complementary" and "integrative" medicine.
Looks like mainstream medicine isn't interested in being "complemented" by or "integrated" into the kind of medicine that is derived from plant parts.
Maybe this experience with the FDA will finally cause Dr. Weil to see the drug cartel for what it is, and adjust his thinking about pharma's cash cow: vaccines.
Posted by: mom4truth | October 20, 2009 at 12:29 AM
I think it is about loosing the natural medications,herbs and other healing methods. It is about loosing your freedom and limiting your choices.It is about total control,you can only buy and take what big Pharma will give you.Just in case if people
start taking ginger/honey,chicken soup with cloves(antioxidant)turmeric(antioxidant,Ester-C,dark fruits and vegetables,control their stressors,drink their chamomile tea,stay well nourished,keep their immune system in top shape and cut out the toxins from their food,cosmetics,vaccines(say No)and STAY STRONG.Slowly,gradually we will loose our freedom,there will be only one way,the Pharma way.I just hate what I see.Population control/reduction and police state is coming.
Posted by: Concerned Professional | October 19, 2009 at 11:29 PM
YES, YES, i agree they put stuff out now without testing it for what the money,and already some have been affected by the flue shot a few we have heard about that has destroyed them in many ways, are they fighting it NO,& many of the old remendy,s 1 of which my mom used on me when she became aware i had ashatma many many yrs. ago & after i grew to certain higeth my astmas was gone & the way they took care of them selves when old this new med,s ect. they didn,t have back then worked as proof my momma is 91 & alot of times still out doing yard work, ect.
Posted by: Linda | October 19, 2009 at 11:01 PM
Teresa Conrick- LOVE your reply. I was debating on prozac, 5htp or lime tree. After reading your post all I need is to keep reading your post. I'm crackin' up here. (i'm also kidding about the prozac)
Posted by: mlmac | October 19, 2009 at 10:37 PM
Sylvia,
Your post had me laughing, too! The bizarre stuff passing as reality is just wacko!
Posted by: Teresa Conrick | October 19, 2009 at 10:04 PM
Terri, your mention of Kevin Trudeau's book is right on target. The FTC has basically made it illegal for anyone to talk about treating or preventing any illness with anything other than a pharmaceutical product.
What I wonder is when the FTC will crack down on all those doctors recommending "diet and exercise" to prevent and treat obesity, high cholesterol, etc. After all, Big Pharma can't patent and sell diet and exercise. Ha-ha, kill me, indeed. We are on a pretty bad path.
Posted by: Theresa | October 19, 2009 at 09:34 PM
Well, I have no sympathy for Dr. Weil. He will NEVER stand up and say vaccines can harm. So many of us have written to him and contacted him and he continues to support them. He's about making money not telling the truth. Holistic stuff is money making for him. And lots more to make money on if a person is ill (from vaccines)
Posted by: Sheri Nakken | October 19, 2009 at 09:32 PM
"More generally, it is against the law to make or exaggerate health claims,............ without rigorous scientific evidence sufficient to substantiate the claims."
OMGoodness --
You can't make this stuff up! I really think we should go to FOX as we now have everything we need for our own autism REALITY SHOW.
Posted by: Teresa Conrick | October 19, 2009 at 09:31 PM
What are they so scared of?
Posted by: Mom23boys | October 19, 2009 at 09:14 PM
Sylvia,
Thank you for my best laugh of the day!(In a ha-ha-kill-me sort of way, to borrow from Gatogorra).
This is business as usual for the FDA. . .ever hear of Kevin Trudeau? He wrote a book; bestseller according to the New York Times: "Natural Cures 'They' Don't Want You to Know About."
But, you know, it's so confusing--do I listen to the million or more parents who are screaming about "vaccine injury," and the doctors, scientists, lawyers, and MDs who support them--or, I don't know--put my child's life in the hands of several out-of-control government bureaucracies?
Posted by: Terri Lewis | October 19, 2009 at 09:00 PM
should we all write the flu task force and ask where it the proof that the vaccine works?
Posted by: KC | October 19, 2009 at 08:51 PM
That Dr. Weil has a lot of nerve! Doesn't he know how much work goes into creating a pandemic virus??? Then all the work that goes into creating the vaccine for it???
H1N1 belongs to the government. They created it, they get to be the saviors with the "cure". They don't need any smartalecks helping out with non-harmful remedies!
Posted by: Sylvia | October 19, 2009 at 08:41 PM
Dr. Weil is not a naturopath, he is a Harvard medical school MD. Everyone should [email protected]!!! And your Senator and Conrgressmen!!
Posted by: Nancy Dah | October 19, 2009 at 08:34 PM
It looks like the Office of Circumlocution strikes again as John Stone (and Dickens) would put it.
So, let me get this straight: they throw the swine flu shot on the market without testing it properly (as if any vaccines were tested properly), but naturopaths can't promote 1,000 year old remedies? It's just funny in a ha-ha-kill-me sort of way.
Posted by: Gatogorra | October 19, 2009 at 08:20 PM
God, the irony of this. Like the CDC or HHS would know anything about "reliable, scientific evidence." They basically assume safety for vaccines and then don't even look at their "VAERS data" to see any problems.
They're probably panicked that the uptake of the swine flu shot for their plandemic is so poor. What next? Will they try to do this with vitamins?
Posted by: jen | October 19, 2009 at 08:16 PM