Supporters of OSR #1, “drug” given to autistic children, see FDA warning as no big deal

24 Jun

The story broke yesterday that Dr. Boyd Haley has been given a warning letter by the FDA about his chelating product, OSR #1. The FDA has warned Dr. Haley that his own safety tests indicate the possibility for adverse reactions and that since the substance is not found in any food or mineral, it is not a “supplement” as he markets it, but a drug. Drugs require much higher standards of proof of safety.

One could make an easy bet that the Age of Autism blog, which has helped tout the drug/supplement OSR, would come to Dr. Haley’s defense. The way they went about this is quite surprising to me. In Chicago Tribune Protecting Consumers Against Natural Supplement (Again), the Age of Autism writes:

CTI Science got a letter from the FDA about its ingredients. They will respond. Dr. Weil got a similar letter last year when he dared to offer an immune support formula in place of the H1N1 vaccine. Drug companies get the letters every day of the week for their advertising claims. You think 50,000 people in America even know what OSR is? They will now.

Yes–the letter from the FDA is no big deal. One of their favorite alternative medical practitioners got one last year, and the pharmaceutical companies get them too. While it isn’t mentioned in the AoA piece, Dr. Weil appears to have ignored the warning letter without any repercussions as no response has been recorded.

Yes, “you don’t have to respond to the FDA’s letters” appears to be a valid excuse to the Age of Autism.

There is a major difference between the warning letters sent to Dr. Haley and Dr. Weil. Dr. Haley’s letter shows that his own safety data, data not previously made public from what I can see, indicates the drug he is selling has the potential to cause adverse reactions. Dr. Weil appears to be only making claims of efficacy which he can’t back up. Only.

And, yes, big companies flout the FDA letters too. Merck, a giant pharmaceutical company, has one warning letter. One. That’s for Vioxx. Merck didn’t respond. That didn’t exactly go well for them, did it?

The full warning letter to Dr. Weil is quoted below.

TO XXXXXXXXX
http://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 http://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.

This product is your Immune Support Formula. The marketing of this product violates the Federal Food, Drug, and Cosmetic Act (FFDC Act). 21 U.S.C. §§ 331, 351, 352. We request that you immediately cease marketing unapproved, uncleared, or unauthorized products for 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 FDAFLUTASKFORCECFSAN@fda.hhs.gov, 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 http://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 FDAFLUTASKFORCECFSAN@fda.hhs.gov 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 flu@ftc.gov 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

15 Responses to “Supporters of OSR #1, “drug” given to autistic children, see FDA warning as no big deal”

  1. Margaret Romao Toigo June 24, 2010 at 14:43 #

    It’s about time! Here’s a link to the FDA’s rather sternly worded letter to Boyd Haley

    http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm216216.htm

    The gears of justice grind slowly over at the FDA, but once they act, watch out…

  2. Anne June 24, 2010 at 18:29 #

    In response to the FDA warning letter, Dr. Weil took corrective action and removed the offending claims from his website. He also posted a notice about it, in which he said “I directed the website team to remove the FDA/FTC-referenced content for review, and they have done so. I fully support the FDA/FTC task force in its efforts.” It remains to be seen whether Dr. Haley will similarly comply with his warning letter by stopping the sale of OSR#1.

  3. Sullivan June 24, 2010 at 19:00 #

    Anne,

    thank you for that. I wanted to check the website to see if the content was removed, and I should have done so before writing this post.

  4. Liz Ditz June 25, 2010 at 20:34 #

    Don’t forget the tireless work of Kathleen Seidel on this issue:

    FDA To Haley: OSR#1 A Misbranded, Mislabeled, Unsafe Drug ·

    http://neurodiversity.com/weblog/article/205/

    …..The warning letter validates observations made in the articles A Fine White Powder, The Industrial Treatment, and An Inquiry Emerges, published on Neurodiversity Weblog in August 2008, shortly after Prof. Haley first offered OSR#1 for sale to the public.

    Fine White Powder
    http://www.neurodiversity.com/weblog/article/168/

    The Industrial Treatment
    http://www.neurodiversity.com/weblog/article/169/

    An Inquiry Emerges
    http://www.neurodiversity.com/weblog/article/170/

  5. Smarter Than You June 25, 2010 at 20:42 #

    Wow everyone watch out for OSR it is so toxic!!! This is huge news!!! But at the same time remember thimerosal is completely safe even though it is 49.6% extreme neurotoxin. Hilarious!!! Get a clue!!!

    • Kev June 25, 2010 at 20:52 #

      Hi STY maybe you could provide some decent evidence that thiomersal is likely to cause autism?

  6. David N. Brown June 25, 2010 at 21:04 #

    Don’t bother arguing with this troll.

  7. Sullivan June 25, 2010 at 23:02 #

    It is a good troll tactic. Let’s argue thimerosal (for the millionth time).

    So what? Assume thimerosal is the most toxic substance ever invented or eve to be invented.

    Does that mean that Boyd Haley should be allowed to bypass the law and market a synthetic substance as a “supplement”? Does that mean that Boyd Haley should call something non-toxic that causes reactions in laboratory mice? Does that mean that Boyd Haley should be allowed to keep his safety data from the public and only have it disclosed by the FDA?

    Perhaps Smarter Than You could live up to his name and point out in which of Boyd Haley’s numerous talks on his chelator is where he mentioned the hair loss, lymph and pancreatic changes observed in the mice he tested. I couldn’t find it.

    Smarter Than You is invited to read the transcripts from the Autism Omnibus, where actual medical toxicologists discussed the “thimerosal causes autism” theory. Where actual autism experts discussed the theory. Where the theory was resoundly rejected.

  8. David N. Brown June 25, 2010 at 23:33 #

    I just noticed an identical comment from “Sty” at Respectful Insolence.

  9. Sullivan June 25, 2010 at 23:38 #

    I just saw that too. My guess is that if we go through all the links on the RI post, we will find that STY has made the same comment on all of them.

  10. Sullivan June 25, 2010 at 23:46 #

    Dang–I was wrong.

    I guess I should feel honored? that STY chose this blog.

  11. Get a clue June 13, 2012 at 19:50 #

    Anything the FDA bans I think is probably pretty safe, anything they approve I avoid like the plague.

Trackbacks/Pingbacks

  1. Tweets that mention Autism Blog - Supporters of OSR #1, “drug” given to autistic children, see FDA warning as no big deal « Left Brain/Right Brain -- Topsy.com - June 24, 2010

    […] This post was mentioned on Twitter by Kev and Liz Ditz, jamie davis. jamie davis said: Autism Blog – Supporters of OSR #1, “drug” given to autistic …: One could make an easy bet that the Age of Autis… http://bit.ly/cqlwLQ […]

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