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Beta-mannan™ of Alotek Company completed a 9 year milestone, says Dr. Joe Glickman, Jr. M.D. Dr. Glickman’s Beta-mannan™ Aloe vera website celebrates its 9th year of satisfying FDA health supplement guidelines. Dr. Glickman has worked hard to accomplish this.
During that time Dr. Glickman has enjoyed lunch with his regional FDA person and says: “My FDA person is one of the nicest people you could ever meet. I thoroughly enjoy meeting with him and look forward to seeing him again.”
Dr. Glickman lives with his family in Whitefish, a tiny town in Montana, and the FDA people don’t get a chance to visit Whitefish very often.
The FDA sent a warning letter to Dr. Glickman back in 2008, and he carefully corrected his website to remove any medical claims that same day in order to be in full compliance with the new FDA rules regarding health supplements. That was 9 years ago.
More information about Dr. Glickman’s website can be found at: http://www.beta-mannan.com
According to Dr. Glickman, the FDA people can be quite helpful when a supplement company is designing a website. The FDA is not allowed to give specific advice on what the website should say, but it is very good at describing what it should not say, Dr. Glickman smiles.
For instance, most health supplement companies are not allowed to make medical claims on their websites or labels for their products without “FDA approval.” If a medical claim is made, then the FDA must classify the product as a drug, and drugs require FDA approval.
It makes no difference if the medical claim for the product is true. That is not the point, and that’s not what the FDA is trying to determine, according to the FDA.
The point is that a medical claim requires FDA approval because making a medical claim automatically reclassifies the particular product or device as a drug or medical device. It’s as simple as that, says Dr. Glickman.
In Dr. Glickman’s situation, he had accumulated a great deal of experience and research regarding Aloe vera over many years. Dr. Glickman had also collected thousands of testimonials.
Dr. Glickman presented his evidence and research truthfully on his website, even quoting articles published in distinguished medical journals. The problem was that this automatically reclassified his health supplement Beta-mannan™ as a drug for FDA purposes.
That’s why Dr. Glickman immediately removed all of the research from his website as soon as he became aware of this distinction.
Once the product is classified as a drug or medical device, due to a medical claim, the FDA will normally send a Warning Letter to the company.
The FDA Warning Letter covers in detail exactly what medical claims the website has made. This can be very helpful to the website designer since all that must be done is simply to remove the medical claims for the products, according to Dr. Glickman.
FDA drug approval cost is currently about $2.56 billion for a single drug and takes over 10 years. The cost and time involved to obtain FDA approval for a product is out of reach for most supplement companies.
More information about the cost of FDA drug approval can be found at: https://www.fool.com/investing/general/2016/04/30/…
That’s why only the large pharmaceutical companies are able to afford and obtain FDA approvals.
That’s also why the large pharmaceutical companies must charge high prices for their drugs. They need to recoup their research and development costs plus make a profit, according to Dr. Joe Glickman.
Dr. Joe Glickman received a Bachelor of Arts degree from the University of Texas in the undergraduate honors program of Plan II, graduated with high honors, and was initiated into the academic Honor Society of Phi Beta Kappa in 1969.
Dr. Glickman received a Doctor of Medicine degree from the University of Texas Southwestern Medical School at Dallas in 1973.
As the Editor-in-Chief of the popular medical books called Phantom Notes™ from 1973 to 1994, Dr. Glickman’s Phantom Notes™ were published in 17 editions in the United States alone and have been sold in over 90% of USA and Canadian Health Science and Medical School Bookstores.
Phantom Notes™ titles can be found on the websites of Barnes and Nobles and Amazon.
Sold in over 30 countries, and translated into several foreign languages, including Chinese, Dr. Glickman’s Phantom Notes™ taught the major medical disciplines of Internal Medicine, Surgery, OB-Gyn, and Pediatrics.
Phantom Notes™ helped train thousands of medical students and nursing students responsible for millions of patients.
Release ID: 171632