On October 30, 2018, the FDA sent a letter to the American Botanical Pharmacy and “Dr.” Richard Schulze – whose “doctorate is in herbology”- stating,
Based on the review of your firm’s website…we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations.”1
Yet on December 8, 2018, the website still had this question and answer posted.
“I am intrigued by your web site and excited about the possibilities of your “Incurables Program.” Having had Type I Diabetes…I have tried countless different diet and lifestyle changes in hopes of curing this disease….Have you had people who have had success with curing their Type I Diabetes with your “Incurables Program“?” ~patient
“I have had many people with Type I Diabetes recover from this disease, cure themselves, heal their pancreas and stop using insulin all together, but most of them needed to make more extreme and powerful changes, and what you were thinking, my Incurables Program is just the place to begin. Follow that and also every step in my “20 Steps” book. Many of my patients, and now hundreds of my customers with Type I Diabetes have been able to cure their disease and STOP taking all insulin by making these powerful lifestyle changes.”2 ~Dr. Schulze
Type I diabetes is an autoimmune condition in which the body destroys the beta cells of the pancreas that produce insulin. Lifestyle changes and using supplements will not cure Type I diabetes. Although the company removed items from the FDA’s detailed list of violations, they still missed this and several other claims of cures with the use of their dietary supplement products.
Use of Supplements and Homeopathy
More than half of the US adult population consume dietary supplements. The dietary supplement industry today is a $35.9 billion a year market and is estimated to grow by 20 billion dollars in the next six years.3 Around six million people in the US use homeopathy, one million of them are children. Unfortunately, many people do not realize that these products are regulated as food. The Dietary Supplement Health and Education Act, passed in 1994, allows these products to be sold without testing for safety or effectiveness and without information on adverse effects or packaging that is child-resistant.4
Distrust of the pharmaceutical industry and an interest in taking control of one’s health are just a couple of the reasons people choose dietary supplements and homeopathy. Unfortunately, dietary supplements and homeopathy are being actively promoted on the Internet in lieu of regulated, mainstream treatments.
Many of these supplements have serious drawbacks. Recent research found that 746 dietary supplement brands from between 2007 and 2016 contained active pharmaceutical drugs, like steroids.5 Teething tablets by Hyland’s Homeopathic were recently discovered to contained belladonna nightshade, a poisonous plant. Linked to deaths of babies last year, the FDA warned consumers not to use these products.6
Hepatotoxicity is a principle safety issue for as many as 60 herbal supplements. Green tea contains ECGC, an antioxidant that is toxic for liver cells. Green tea based herbal supplements containing other ingredients have been implicated in liver damage requiring liver transplant.7 It shouldn’t be surprising to learn that a 2015 study of emergency room visits in the US estimated that over 23,000 emergency department visits per year can be attributed to adverse events caused by dietary supplements. These visits resulted in an estimated 2,154 hospitalizations.8
It’s important to be careful and wary of what is advertised as supplements. Remembering that the FDA does not test these products for safety or effectiveness before they are sold to you. It is only when a problem arises and the FDA is notified, that warnings and recalls occur.
7 DOI: https://doi.org/10.1016/j.jpeds.2018.05.022
8 DOI: 10.1056/NEJMsa1504267