Makers of ear candle products are disputing a recent FDA warning that their products are unsafe or unapproved medical devices. Some 15 ear candle companies in total received the Warning Letters from the FDA, with the agency requesting that companies immediately cease marketing and distributing these products.

FDA also posted an article on its website entitled "Don't Get Burned: Stay Away From Ear Candles," which claimed that ear candles can cause serious injuries, even when used in accordance to manufacturers' directions, and expressing that FDA believes there is no valid scientific evidence for any medical benefit from their use. According to the FDA, ear candles are improperly marketed by some companies for treating earwax buildup, sinus infections, hearing loss, headaches, colds, flu and sore throats.

But according to M. Harmony Cone, PhD, founder of Harmony Cone Ear Candles (Douglasville, GA), one of the 15 companies that received the FDA Warning Letter, "Ear candles do not remove wax or anything else from the body. And, as such, ear candles are not a medical device."

"Ear candle companies have recently come under fire for marketing violations under the 'guise' that ear candles are medical devices," she continued. "They are being accused of not having the proper paperwork for a medical device. However, this is confusing as on the one hand the FDA states that the ear candle is a medical device, but then they state it has no medical value. So I have to ask, how can something be called a medical device if it has no medical value? Once again, it is our position that ear candles are holistic and not a medical device, and they certainly do not remove wax.

"There are some companies that misrepresent the history of ear candling, for example, by using the Hopi name, to market their product, or state that the product purifies the blood, strengthen the brain, or can even 'cure' cancer! How ridiculous!" stressed Cone. "It is our desire that the FDA should focus its energy on those who would make such unproven claims. But let's not destroy an opportunity to help the body help itself-which is what we feel ear candles actually do."

According to the Harmony Cone website: "Ear candling has been an ancient practice through the ages, and generations of families around the world agree ear candle therapy is a rewarding holistic remedy... Ear candles are not medical devices, therefore they can not remove objects, including wax, yeast/candida, bacteria and/or fungus from the ear... Current worldwide research indicates that ear candles function as an energetic modality comparable to the fields of reflexology and acupuncture. These modalities encourage healing when the body shifts from a sympathetic to a parasympathetic state within the autonomic nervous system (ANS) when the body naturally relaxes. Many practitioners believe that this shift in the ANS enables the body to heal itself throughout the whole body, including the ear, sinus and lymphatic systems."

The website further quotes Cone as saying that "We have always led this category with the safest, cleanest burning ear candle on the market. I have personally ear candled over 10,000 people and have never injured or harmed anyone, ever."

Another company receiving the FDA Warning Letter was Wally's Natural Products (Auburn, CA). Said Manager Dave Reese, "This is a big deal to us. Customer safety is our No. 1 priority at all times," adding that a safety filter tip on their product offers consumers protection against hot wax.

On the issue of medical devices, Reese remarked that "we don't consider our products medical devices by any means. We're currently working with the FDA to figure this out and we're very optimistic."

The findings are published in the current issue of Experimental Biology and Medicine.

“As we all eventually learn, aging diminishes our mind, fades our perception of the world and compromises our physical capacity,” said David Rollo, associate professor of biology at McMaster. “Declining physical activity—think of grandparents versus toddlers—is one of the most reliable expressions of ageing and is also a good indicator of obesity and general mortality risk.”

The study found that a complex dietary supplement powerfully offsets this key symptom of aging in old mice by increasing the activity of the cellular furnaces that supply energy, or mitochondria, and by reducing emissions from these furnaces, or free radicals, that are thought to be the basic cause of aging itself.

Most of the primary causes of human mortality and decline are strongly correlated with age and free-radical processes, including heart disease, stroke, type 2 diabetes, many cancers, neurodegenerative diseases and inflammatory and autoimmune conditions, the researchers said. Successful intervention into the aging process could consequently prevent or forestall all of these.

Using bagel bits soaked in the supplement to ensure consistent and accurate dosing, the formula maintained youthful levels of locomotor activity into old age whereas old mice that were not given the supplement showed a 50 percent loss in daily movement, a similar dramatic loss in the activity of the cellular furnaces that make energy, and declines in brain signaling chemicals relevant to locomotion. This builds on the team’s findings that the supplement extends longevity, prevents cognitive declines and protects mice from radiation.

Ingredients consisted of items that were purchased in local stores selling vitamin and health supplements for people, including vitamins B1, C, D and E, acetylsalicylic acid, beta carotene, folic acid, garlic, ginger root, ginkgo biloba, ginseng, green tea extract, magnesium, melatonin, potassium, cod liver oil and flax seed oil. Multiple ingredients were combined based on their ability to offset five mechanisms involved in aging.

For Rollo, the results go beyond simply prolonging the lifespan.

“Aging humans maintaining zestful living into later years may provide greater social and economic benefits than simply extending years of likely decrepitude,” he said. “This study obtained a truly remarkable extension of physical function in old mice, far greater than the respectable extension of longevity that we previous documented. This holds great promise for extending the quality of life or ‘health span’ of humans.”

Development of new and hopefully more effective supplements is ongoing.

Funding for this study was provided by the Natural Sciences and Engineering Research Council of Canada.