Harmony Cone files Citizen Petition against FDA

Harmony Cone files Citizen Petition against FDA

Company leads the charge in ensuring protection for ear candles.

Harmony Cone Ear Candles, a part of good energy hygiene, are a synergistic approach to relaxation that enhances sense of well-being. Worldwide, people seek peace, relaxation and a moment of happiness to balance the opposing rigors and stress of everyday life. People desire and need a feeling of security, peace of mind and sense of personal well-being. Harmony Cone Ear Candles are an integral part of enhancing that sense of well-being.

Also important is the sustainability of the natural holistic products that consumers choose to use every day. Harmony Cone Ear Candles are the only ear candles to use certified-organic cotton in the specialized handcrafted process. We ardently support and defend the right of people to choose those products that best suit and safely fulfill their needs.

However, in February 2010, the FDA issued Warning Letters against 17 different manufacturers of ear candles alleging regulatory violations that stated that ear candle manufacturers were: (1) distributing and selling “medical devices” without the proper regulatory permits, (2) marketing those devices to children, (3) making unsupported claims about what ear candles do for users, and, most importantly, (4) that ear candles were physically injurious to users. FDA threatened further enforcement actions against those manufacturers if they continued to make, distribute or sell their products.

An administrative meeting, held on March 26, 2010, with 12 directors and agents of the FDA, Agent Larry Spears, FDA deputy director for regulatory affairs, Office of Compliance stated, "... we are not going to approve any ear candles for use in the market ... this is our position." There was no trial with regular proceedings and rules to legally challenge the arbitrary and capricious administrative decisions of the FDA.

As a result, Harmony Cone spearheaded an action in the U.S. District Court, for the Federal Circuit in Washington, D.C. The suit was dismissed upon grounds that the agency action was not final and that the plaintiff manufacturers lacked standing to sue. Appeal was taken all the way to the U.S. Supreme Court on whether the agency action was final and that the plaintiffs’ had a right to proceed to trial of the cause. At each appellate stage, the decision of the U.S. District Court was upheld either by decision or by declining to hear the case and issues presented.

To resolve the lack of standing issue, Harmony Cone Ear Candles decided to file a citizen’s petition before the FDA to obtain a final decision and agency action on several issues. The issues presented in the administrative action are: 1. Ear Candles are not a medical Device, 2. The establishment of raw material guidelines for consumer safety to include a patented safety tip, and 3. Marketing guidelines for truth in advertising with regards to ear candle products.

Harmony Cone Ear Candles, is once again taking the lead by attempting to work with the FDA to protect and improve a modality that has been used millions of times by customers around the world without any injury or harm.

Harmony Cone Ear Candles is asking interested persons to submit comments on our citizen petition, which comments become part of the docket file. The comments must specify the docket number of the petition and may support or oppose the petition in whole or in part.

The Docket Number for our citizen petition is FDA-2013-P-1297/CP1.

Comments to the citizen petition may be submitted online at Regulations.gov. Here is the link to your citizen petition: http://www.regulations.gov/#!docketDetail;D=FDA-2013-P-1297. (Be patient, it might take a few seconds for the content to appear.)

Comments may also be mailed to Dockets Management Branch, Food and Drug Administration, Room 1061, 5630 Fishers Lane, Rockville, MD 20852.

We invite all to share their experiences with ear candles. harmonycone.com

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