Posted July 11, 2017

FDA Warns Dr. Carolyn Dean of Drug Claims Made for Magnesium, Calcium & Other Mineral Supplements

On June 27, 2017, the FDA issued a Warning Letter to Dr. Carolyn Dean of New Capstone, Inc. because statements and testimonials made on the company's website about certain products, including ReMyte, ReAline, ReMag, ReStructure, and ReCalcia Pico Meter Calcium were found to be drug claims:  

These statements, which were made on the website RNAreset.com, include: 

ReMyte

  • "ReMyte includes Boron, Copper, Chromium, Iodine, Selenium, and Zinc, all of which have bery specific roles...in...cancer prevention..."
  • "Boron is being investigated as a treatment for the following conditions: congestive heart failure, high cholesterol, arthristis, gout, [and] osteoporosis"
ReAline

  • "[R]educes brain inflammation"
  • "[T]o help reduce...depression"
ReMag

  • "[T]reats heart disease... muscle pain and spasm, nerve problems"
  • "[H]elp[s] solve many of the chronic disease problems"
  • "[F]or injury, pain, and arthritis"
  • "[F]or painful injuries"
  • "When I began using the right type of magnesium, ReMag, I finally found relief for... heart palpitations, charley horses, insomnia, muscle twitching, low back pain, and neck pain"
[Note: ConsumerLab.com tested this product in 2017, as part of its Magnesium Supplements Review.]

ReStructure

  • "[R]educing the risk of heart disease"
  • "Assists in lowering cholesterol"
ReCalcia Pico Meter Calcium

  • "Vanadium is being studied in...heart disease"
See ConsumerLab.com's Reviews of Calcium Supplements and Magnesium Supplements for tests of related products.

The FDA requested that corrective actions be taken and that failure to do so may result in enforcement action without further notice, such as seizure and/or injunction.

See related warnings:

Seller of Herbal Supplements Warned for Manufacturing Violations, Drug Claims

Life Extension Warned for Drug Claims

Seller of Vision, Cholesterol, Prostate Supplements and More Warned for Drug Claims

Seller of "Cancer Kits," Alpha Lipoic Acid Supplements and More Warned for Drug Claims

Seller of Heart, Senior and Teen Supplements Warned For Drug Claims

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