Natural Solutions Foundation
www.HealthFreedomUSA.org
Natural Solutions Foundation is one of the Plaintiffs in the case of Holistic Candlers and Consumers Association et al v FDA et al. – http://drrimatruthreports.com/?p=5210.
During February 2010 the Food and Drug Administration, with an excess of zeal, ordered the 15 known Ear Candles companies in the United States to cease all activities, since the agency now deems Ear Candles “medical devices” without hearing from the Public, findings of fact, Significant Scientific Agreement or other substantiating or supporting reason, evidence of science. Holistic ar candles have been used for decades if not centuries, for relaxation and general wellness for decades. Americans have used them prior to 1976, when the agency was given power over “medical devices.” Ear Candles are not medical devices. FDA says they have “no” medical uses and therefore could never even be approved as “medical devices.” They are a traditional, natural product that promotes relaxation and the health benefits of relaxation.
We therefore deplore the FDA’s action, which, in effect, censors what Americans can say commercially about Holistic Ear Candling. This is wrong and violates the Constitution as interpreted by the Supreme Court.
We cite the case of Thompson v. Western States Medical Center (535 U.S. 357, 2002). This case concerns a clause in the Food, Drug and Cosmetics Act that allows pharmacists to “compound” medications for specific prescriptions without safety testing and FDA prior approval, but originally forbade pharmacists from advertising the specific compounds they make. The Supreme Court held that the restriction on Commercial Speech was unconstitutional. Some of the language used in Justice O’Connor’s Majority Decision that sets the tone is as follows:
“If the First Amendment means anything, it means that regulating speech must be a last – not first – resort… We have previously rejected the notion that the Government has an interest in preventing the dissemination of truthful commercial information in order to prevent members of the public from making bad decisions with the information… Even if the Government did argue that it had an interest in preventing misleading advertisements, this interest could be satisfied by the far less restrictive alternative of requiring … a warning that the [product] had not undergone FDA testing and that its risks were unknown.”
The law already forbids the making of medical claims with regard to products such as Ear Candles. Therefore removing the product from the market is an unnecessary interference with the choices of adults regarding their own private activities.
We salute Ron Paul’s letter to the FDA dated May 25, 2010 demanding answers from the FDA as to why the agency has taken this unconstitutional action.
This is why we hold that “Health Freedom is Our First Freedom” because without it, our other liberties may not be effectively exercised!
Dr Paul’s letter reads in part: “I am writing regarding the numerous warning letters … sent to the manufacturers of ear candles suggesting that ear candles are a medical device requiring premarket applications… the result would be to deny some people access to the product… I have been made aware that there is a dispute over whether ear candles meet the definition of a medical device. Furthermore, I am aware that there are claims that, even if ear candles meet the statutory definition of a medical device, they likely fall within the exemptions granted Class I generic devices. Thus, it is questionable whether the FDA’s letters … reflect a proper classification of ear candles… I have also been informed that there are very few adverse events reports… It seems that concerns about the safe use of ear candles could be addressed by requiring the distributors of ear candles to include risk warnings and proper use instructions…”
Thank you Dr. Paul for once again defending the rights of the people against the abusive power of the federal agencies!
Also posted at Campaign for Liberty: http://www.campaignforliberty.com/blog.php?view=35823
