H1N1 Warning Letter for “Dr. Coldwell”

June 4, 2010

H1Ni Warning Letter

Snake Oil for Swine Flu

This one is a doozy as FDA continues to take on phony H1N1 cures. It hearkens back to the days of snake oil remedies that helped lead to passage of the Pure Food & Drug Act of 1906, along with the crusading novel, “The Jungle” by Upton Sinclair. The remedy is called, I kid you not, “Dr. Coldwell’s Anti-Viral/Flu Protocol,” and is taken over a 30-day period to ward off “Swine Flu.” Hopefully, with summer upon most of us (I live in the Pacific Northwest where summer is evidently illegal), we won’t be seeing many more.

UPDATE- Health fraud on a different topic from the FDA Alumni Association: FDA is warning consumers not to take Miracle Mineral Solution, an oral liquid also known as “Miracle Mineral Supplement” or “MMS.” The product, when used as directed, produces an industrial bleach that can cause serious harm to health.

The FDA has received several reports of health injuries from consumers using this product, including severe nausea, vomiting, and life-threatening low blood pressure from dehydration.

Consumers who have MMS should stop using it immediately and throw it away.

MMS is distributed on Internet sites and online auctions by multiple independent distributors. Although the products share the MMS name, the look of the labeling may vary.

The product instructs consumers to mix the 28 percent sodium chlorite solution with an acid such as citrus juice. This mixture produces chlorine dioxide, a potent bleach used for stripping textiles and industrial water treatment. High oral doses of this bleach, such as those recommended in the labeling, can cause nausea, vomiting, diarrhea, and symptoms of severe dehydration.

MMS claims to treat multiple unrelated diseases, including HIV, hepatitis, the H1N1 flu virus, common colds, acne, cancer, and other conditions. The FDA is not aware of any research that MMS is effective in treating any of these conditions. MMS also poses a significant health risk to consumers who may choose to use this product for self-treatment instead of seeking FDA-approved treatments for these conditions.

Read the Warning Letter for “Dr. Coldwell’s Protocol.

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Scam “clinical trial” targets the hard of hearing

December 30, 2009

It was enough to make my blood boil. A family member who has hearing problems passed me an announcement for a “Field Trial Notification” that contained wording that made it sound like a legitimate clinical trial. Things like, “You have been selected to receive this invitation to participate in this study” and “We will be selecting only 20 local residents as candidates for this field test at this time.” The notice gave three “inclusion criteria” similar to what you would see in a legitimate ad for a clinical trial. However, these folks are just peddling their product. There is no research going on and people who answer the ad are going to have to pay a price, which is never stated, for the hearing aid.

There are some dead giveaways that this isn’t a study of any kind. Three things are:

1. There is no clear statement of research, only the suggestion of a “study” and a “field test.”

2. It uses language such as “incredibly discreet” and “comfortable.”

3. It states that “Your satisfaction is 100% guaranteed.”

If this was a legitimate clinical trial an institutional review board (IRB) would have to approve the language in all advertisements and no legitimate IRB would ever allow such suggestive language. This is a scam to try to sell a particular brand of hearing aid, pure and simple. This type of deceptive advertising has been around since they invented snake oil. Its one of the reasons we have an FDA. The new leadership at FDA seems intent on going after the most fraudulent shysters, particularly with phony H1N1 “cures.” They’ve got a big job in front of them.

I’m all for alternative therapies and have an appointment with my acupuncturist tomorrow. I know some fine people using homeopathic medicines. There are also a lot of frauds out there and the ones who target seriously ill people with difficult health problems for nothing other than personal gain should be tarred & feathered and run out of town on a rail. (In my humble opinion.)


Dr. Hamburg says that FDA will step up “effective enforcement”

August 7, 2009

In a speech to the Food and Drug Law Institute Dr. Margaret Hamburg, the new FDA Commissioner, outlined a six step program to increase enforcement of FDA regulations. Stating that there had been a steep decline in enforcement actions, coupled with unreasonable delays in following through on serious public health problems, Hamburg stated in unequivocal terms that things were changing immediately to increase consumer protections and change the direction of FDA.

A review of recent FDA Warning Letters shows that there has indeed been an increase in enforcement and that there is a new emphasis on enforcement actions and a change in the climate at FDA from the previous administration. My hunch is that food good manufacturing practice (GMP) inspections will lead the way in receiving FDA attention with other GMP programs not far behind. However, when there is a change in the FDA enforcement climate it impacts all inspectional programs. Dr. Hamburg also signaled an increased scrutiny of internet health fraud. She emphasized the need to follow-up when FDA has found serious problems.

In some cases, serious violations have gone unaddressed for far too long,” Hamburg said. “These include violations involving product quality, adulteration, and misbranding; false, misleading, or otherwise unlawful labeling; and misleading advertising,” Hamburg stated. The entire address is available on the FDA homepage at http://www.fda.gov

Here is an outline of Dr. Hamburg’s six step program which is excerpted from the FDA website, with my comments in parenteses:

“First, the FDA will set post-inspection deadlines (for violative inspections).

Second, the FDA will take responsible steps to speed the issuance of warning letters (the exact opposite of 2001).

Third, the FDA will seek to work more closely with our regulatory partners (local, state, and international regulatory agencies) to develop effective risk control and enforcement strategies. (FDA has long worked closely with the states but has a poor history of international cooperation)

Fourth, the FDA will prioritize enforcement follow-up. After a warning letter is issued or a major product recall occurs, we will make it a priority to follow up promptly with appropriate action.

Fifth, the FDA will be prepared to act swiftly and aggressively to protect the public. The FDA will no longer issue multiple warning letters to noncompliant firms before taking enforcement action (this is a dramatic change from current practice).

A sixth new practice is a little different from the others. It relates to our response to firms after they have made necessary corrections.

At my direction, the FDA is developing a formal warning letter “close-out” process. If the FDA can determine, usually based on a re-inspection, that a firm has fully corrected the violations raised in a warning letter, we will provide to the firm a “close-out” letter, indicating that the issues in the warning letter have been successfully addressed. To keep the public informed, we will indicate on our website when a firm has received a “close-out” letter.” (lose out letters for warning letters is something very new. It might help give a warning letter more clout and ce rtainly gives industry a motivation to clean up their act.)

CThen Dr. Hamburg gave two examples of FDA’s new enforcement posture. The quick action issuing Warning Letters to internet websites selling fraudulent products for the H1N1 influenza virus (swine flu) and a crackdown on “nutritional supplements” that contained illegal anabolic steroids.

Now here are my two complaints regarding Dr. Hamburg’s speech. While cracking down on the sales of clearly fraudulent products is commendable and something FDA has not done effectively for years, it is not a bold initiative. In fact, it is picking the low hanging fruit. These are easy enforcement actions to obtain because the violations are so blatant. Large food companies and big pharma seem to be left out of this push towards tougher enforcement standards. Or maybe I am being impatient.

Second, during the question and answer period, a food and drug attorney asked Dr. Hamburg about the lack of regulations for an increasingly complex regulated industry. She side-stepped the question and instead spoke of greater government transparency. That is too bad. FDA’s clinical trial regulations were written 35 years ago for a very different clinical trial industry. There are no regulations or enforcement for the huge clinical trial services industry including clinical laboratories and site management organizations. Computerized systems and part 11 compliance is something FDA rarely discusses. Combination products don’t have the level of regulatory oversight they need. There are a lot of areas that FDA needs to modernize and address.

Still, Dr. Hamburg only has been in office for eight weeks. She is certainly setting a different tone than in the past eight years. She mentioned Congressional support and increased funding for inspections and enforcement. This sounds like large steps in the right direction.


The Blog enters the world of movie reviews

May 11, 2009

When you are the author of an internationally famous Blog on FDA Stuff and you’ve had over 200 hits the past week, you know its time to take on Hollywood. I just saw Duplicity with Clive Owens and Julia Roberts at the Blue Mouse, the last single screen theater in the Northwest. Movies only play at the Blue Mouse after they’ve played everywhere else they possibly could. So if you want to see Duplicity you will probably have to wait to rent it.

When I first began working at FDA (a former employer), I answered the phone at the San Francisco District’s Consumer Affairs Office. One of my first calls was about a drug, now widely available, that would grow peach fuzz where men had grown bald. “When is it going to be approved?” the caller asked desperately. I soon learned that cures for baldness, along with weight loss gimmicks and impotence potions were very big business.

Which leads us to Duplicity. At first I thought it had been written by a computer geek obsessed with Part 11 of the FDA regulations on computerized records. There is a lot of security system hocus pocus that is pretty cool. Then, about three quarters through the movie, the plot thickens, so to speak. Anyway, when you want a fun, lightweight movie to rent, please consider Duplicity. It’s about industrial espionage and products that go bang in the night. Without FDA approval, I might add. I’ve added a link to the Duplicity website under the Blogroll. Have fun.


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