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Supreme Court Refused Ephedra Appeal…
May 17, 2007 01:39 PM
Supreme Court Refused Ephedra Appeal…The U.S. Supreme Court on Monday refused to consider an appeal by Nutraceutical International Corporation, which sought to overturn a federal ban on the dietary supplements containing ephedrine alkaloids. The court’s decision, issued without comment, lets stand a 2005 ruling by a federal Appeals court that upheld the Food and Drug Administration’s (FDA) 2004 ban. David Seckman, executive director and CEO of the Natural Products Association commented on the refusal. “Obviously we were concerned about the consequences of the circuit court’s ruling on the risk benefit standard the FDA used in removing ephedra from the market, which is why we filed our amicus brief. As we clearly stated in the brief, we believe congress did not intend for such a standard to be used. But, since the Supreme Court decides to take up only between five and ten percent of cases brought to it, it is not a shock that they’ve decided not to hear it. We should note, however, that the denial of the Nutraceutical petition is not an affirmation by the Supreme Court that they agree with the lower court’s decision,” Seckman said. In April, the Natural Products Association had filed a “friend of the court” or amicus brief with the U.S. Supreme Court that challenged the lower court ruling on the standard used by the FDA to impose a 2004 ban on ephedrine alkaloids in dietary supplements.
Solaray - Ultimate Nutrition - Actipet Pet supplements - Action Labs - Sunny Greens - Thompson nutritional - Natural Sport - Veg Life Vegan Line - Premier One - NaturalMax - Kal
Ban against ephedra supplements at any does upheld.
August 22, 2006 11:48 AM
A three-judge panel of the 10th U.S. Circuit Court of Appeals in Denver late last week overturned a 2005 ruling by a Utah district court that had allowed the sale of low-dosage ephedra dietary supplements containing 10 milligrams or less of ephedrine alkaloids.
The appellate decision, which is effective immediately, supports FDA’s original determination that no dosage of ephedra is safe for consumption and means that it is unlawful to manufacture and sell any supplements containing ephedra, even products containing low doses of the herb.
The original ban was challenged in a May 2004 lawsuit by Nutraceutical Corp, and its subsidiary Solaray Inc., which said dried whole-herb ephedra sinica - the type of supplement in their products – had been safely used for thousands of years.
The U.S. district judge in Utah blocked any enforcement action against Nutraceutical for selling supplements containing 10 milligrams or less of ephedra per daily dose. The Utah District Judge said FDA’s process in banning ephedra improperly shifted the burden of proving product safety from the government to supplement manufacturers.
While noting that the Dietary Supplement Health and Education Act of 1994 (DSHEA) categorized dietary supplements as foods and are not, therefore, subject to premarket approval by FDA, the appellate panel found that the Utah district court had interpreted this basic provision to narrowly.
The panel said that the Food, Drug and Cosmetic Act (FDCA), of which DSHEA is a part, should not be interpreted “too restrictively” but should instead be read in a manner “consistent with the statute’s overwhelming purpose to protect public health.”
Nutraceutical’s attorney has indicated that the company would appeal the ruling to the full Appeals court.
Court Rules for FDA in Lane Labs Appeal
December 12, 2005 09:44 AM
A federal Appeals court has ruled that Lane Labs (Allendale,NJ) may be ordered to pay back consumers for selling what the food and drug administration (FDA) considered unapproved new drugs. The three-judge panel upheld the 2004 decision by U.S. district Judge William G. Bassler of the District of New Jersey, which stated that FDA may demand that Lane Labs pay back every consumer who had bought the company’s top selling products—shark cartilage supplements that were allegedly marketed as treatments for diseases including cancer and HIV. The restitution amount is estimated at 109 million. The Appeals court rejected the argument that FDA cannot demand restrictions because the Federal Food, Drug, & Cosmetic Act (FDCA) does not expressly provide for such a remedy. “Whether or not congress specifically contemplated restitution under the FDCA, the ability to order this remedy is within the broad equitable power granted to the district courts to further the economic protection purposes of the statute,” 3rd Circuit Judge Marjorie O. Rendell wrote in an opinion joined by Judges Maryanne Trump Barry and Edward R. Becker.
In its appeal, Lane Labs was supported by an amicus brief from the Washington Legal Foundation (WLF, Washington, DC) urging the court to reverse Bassler’s decision, on the grounds that restitution is not authorized anywhere in the text of the FDCA.
WLF attorneys Daniel J. Popeo and Richard A. Samp, joined by attorney Jeffrey A Lamken of Baker Botts in Washington, DC, argued that the FDCA gives courts the power to “restrain” violations, but does not allow FDA to seek “Backward-looking monetary relief.”
WLF argued that FDA, throughout most of its history, never asserted a right to seek restitution until recently, when it began asserting that power in order to have “a big club with which to intimidate manufacturers who might otherwise seek to challenge FDA directives,” including large pharmaceutical companies. However, the court upheld FDA’s authority to seek restitution on the grounds that the FDCA’s grant of authority to restrain violations of the Act should be read broadly to include all forms of equitable relief.
FDA cannot be allowed to get away with this power grab,” said Samp after reviewing the Third Circuit’s decision. “The American economy suffers, and public safety and health are jeopardized, when FDA seeks to exert power beyond its authority, upsetting to delicate balance struck by Congress in its attempt to both preserve the public welfare and encourage valuable pharmaceutical innovations.” He added that WLF has pledged to continue to litigate the issue and to support Lane Labs in any further Appeals the company may file.
What the Medicine Men Knew
June 12, 2005 02:17 PM
What the Medicine Men Knew by Phyllis D. Light, RH, AHG Energy Times, August 4, 2003
When Europeans first landed on the shores of North America, they were greeted by Native Americans who were healthy and strong, tall and straight-boned, and who generally lived to a ripe old age. Curious and friendly, the Native Americans showed the newcomers how to harvest wild foods and grow suitable crops, and also demonstrated the medicinal use of herbs. The North American indigenous medical traditions evolved into an effective system during its long history, estimated at between 12,000 and 40,000 years. So, herbally, we owe a huge debt to the Native American willingness to share knowledge of North American plants. Many of the herbs sitting on the shelves of natural food stores today were originally found in the medicinal arsenal of Native Americans, including black cohosh, echinacea, goldenseal, pleurisy root, sarsaparilla, red root, black walnut, gravel root and American ginseng.
Unique Healing Traditions
The number of Native tribes in the United States is estimated at about 500, and each possesses a unique set of healing traditions. While the term "Native American medicine" does not describe a homogenous system of healing, common, underlying principles can be discerned in many of these tribal traditions. Most often, these healing traditions and practices have been handed down in a rich oral tradition from practitioner to practitioner, rarely finding their way into written descriptions.
For instance, according to David Winston, a Cherokee medicine priest and herbalist living in New Jersey, "Cherokee medicine is based on connection-body, mind, spirit, family, community and God/Spirit. The Cherokee word for medicine, Nvowti, means 'power.' Anything that has power-water, ceremony, songs, stories, herbs-is medicine."
On the other hand, Charles Alexander Eastman, PhD (Indian name: Ohiyesa), comments in his book, The Soul of an Indian, "The Sioux word for the healing art is wah-pee-yah, which literally means 'readjusting or making anew.' Pay-jee-hoo-tah, literally 'root,' means medicine, and wakan signifies 'spirit' or 'mystery.' Thus the three ideas, while sometimes associated, were carefully distinguished."
Native American healing philosophy advocates a customized treatment plan for each person's unique health problems.
Consequently, healing techniques focus on the individual, not the disease, although the overall treatment may incorporate well-known ways for relieving the specific discomforts, aches and pains associated with an illness. Native healers employ herbs, ceremony, song and prayer in a manner tailored to each person they treat.
A central tenet in many Native American healing traditions is the need to sweat. As a result, Inipi, or Lakota sweat lodges, are located in most areas of the country. Sweating produces many benefits. It opens pores, cleanses the skin, enhances circulation, discourages the growth of bacteria in the body and functions as a detoxification outlet.
The skin is well-suited for the elimination of toxins: Experts estimate that during everyday functioning, 30% of the body's wastes pass through the skin. For the Native American, the sweat lodge offers spiritual help as well as physical aid. And the use of sweating is generally not employed as the only treatment but is always accompanied by other therapies such as herbs.
Native Americans are not alone in their reverence for using sweating to treat disease. A technique for sweating is fundamental to most traditional medicines, including Ayurveda and Traditional Chinese Medicine.
Native American Herbs
For native healers, herbs offer physical, emotional and spiritual support. In this tradition, herbs are consumed in teas, tablets or capsules, or are inhaled after being thrown onto the hot stones in a sweat lodge or otherwise burned to release their vapor. Smudging, a ritualized method for bathing a person or object with the smoke from sacred herbs such as sweet grass, sage or cedar, is a way of cleansing individuals, clearing a ritual space or sanctifying ceremonial tools. Each herb in the smudging process is used for a specific reason. Sweet grass grows the spirit, while sage and cedar dispel negativity. Frequently, herbs are taken as preparation for participation in rituals. "Sweet leaf is used as a tea before the sweat lodge ceremony in some Indian communities in South Dakota," notes Matthew Wood, RH, AHG, author of The Book of Herbal Wisdom (North Atlantic Books). "It promotes perspiration, relaxes the nerves, reduces tension and brings harmony and beauty to the participants."
The idea that everything in the universe, including people, is connected is a philosophy shared by many tribes.
When a medicine person assesses an illness, she not only observes physical problems but also analyzes family and community dynamics. A person's relationship with God is believed to influence health. In this vein, prayers like Mitakuye Oyasin, a Lakota blessing that means "all my relations," Appeals to the interconnectedness of each of us with other people, with the Earth, and with God.
"Separation and isolation is one of the leading causes of illness," David Winston says. "There is a connection between everything-within ourselves and outside of ourselves. When we isolate and separate ourselves from our family, our community and from God/Spirit, then we suffer diseases of the spirit. Ultimately, we are responsible for our own spirits-to keep them healthy.
"In addition," adds Winston, "from the Cherokee viewpoint, the nuclear family is seen as too small. There are too many single parents working too hard and under too much stress." In a Native American clan-based society, much of this stress is defused with the support of an extended family.
Kinship philosophy is a basic part of the Native perspective, a kinship that extends beyond humans to all life, including animals, fish, and birds as well as the Earth itself. Consequently, care of the Earth is an integral part of kinship philosophy. Indigenous cultures have very specific knowledge of ecology and environmental ethics. In the kinship philosophy, damage done by man to the Earth is then reflected back in the body of man by diseases of the body and spirit. Man and his illnesses are seen as part of the ecology of the planet, not a separate, isolated force with the power to control.
Modern Ills, Ancient Treatments
Winston believes that Cherokee medicine offers the greatest aid to people with chronic illnesses such as chronic fatigue, fibromyalgia and some female reproductive complaints, as well as individuals with stress-related disorders. It can also offer aid to those who are depressed and feel alienated or disconnected from society.
Native American medicine can offer balance and healing. It can be used in conjunction with Western medicine, providing a holistic and individualized treatments. To find a Native American healer, check with your local tribal community. Mitakuye Oyasin.