Letter to the Editor

| July 1, 2018

Regarding Statement from FDA Commissioner on New FDA Actions to Keep Consumers Safe from the Harmful Effects of Sun Exposure, and Ensure the Long-term Safety and Benefits of Sunscreens

Dear Editor:

Ferndale Healthcare, Inc., would like to comment as the distributors of Heliocare capsules, on the “Statement from the FDA Commissioner Scott Gottlieb, M.D. on New FDA Actions to Keep Consumers Safe from the Harmful Effects of Sun Exposure, and Ensure the Long-term Safety and Benefits of Sunscreens.”1

In his Statement, Dr. Gottlieb draws attention to certain “products purporting to provide protection from the sun that aren’t delivering the advertised benefits.  Instead they’re misleading consumers, and putting people at risk.”  Dr. Gottlieb goes on to state the actions that the FDA is taking to protect consumers and hold to account the companies that make the products in question.  Said companies have received warning letters from the FDA. 

We fully support these and any initiatives that preserve the health and well-being of the general public. 

As many dermatologists have pointed out to us and to their patients, Ferndale Healthcare has only ever recommended that it’s Heliocare products be considered for use alongside other forms of protection from free radical damage to the skin – never as an alternative or as a replacement.  We make it very clear that Heliocare is not a sunscreen.   

Heliocare is an antioxidant dietary supplement that helps maintain your skin’s ability to protect itself against the aging effects of free radicals*. The product has been used extensively, worldwide over the course of many years and has been shown to be extraordinarily safe.  

The manufacturers of Heliocare have a proprietary formula that goes to extreme lengths to ensure quality and product consistency.  Heliocare products meet the highest quality standards and are certified to comply with Good Manufacturing Practices. 

Unlike other product in the category, Heliocare has been the subject of extensive clinical research and it is the information from this research that enables medical practitioners to determine the suitability of incorporating Heliocare into skin care regimens for given patients.

We have been informed by many practicing dermatologists that, used properly, Heliocare can be a safe and valuable addition to the skin care regimen of their patients.

With regards,

Ann M. Smith

President & CEO

Ferndale Healthcare, Inc.

* This statement has not been evaluated by the Food and Drug Administration.  This product is not intended to diagnose, treat, cure, or prevent any disease. 

Reference

  1. United States Food and Drug Administration. Statement from FDA Commissioner Scott Gottlieb, M.D., on New FDA Actions to Keep Consumers Safe from the Harmful Effects of Sun Exposure, and Ensure the Long-term Safety and Beenefits of Sunscreens. 22 May 2018. https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm608499.htm. Accessed 5 July 2018. 

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