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Non-Traditional "Substances" Covered Under DHSEA or Drug Regs
References:
2. Non-Drug Alternative To Viagra
4. Vitamin E as a "drug" or "cosmetic" or "vitamin?"
5. Sulfur: The most vital nutrient for skin
6. Non-Drug Alternative To Ritalin
Medi-Cell Laboratories' Age Lift Series anti-aging products part of company's Hydrox-C line
00-00-0000 The new Age Lift Series of anti-aging products, by Medi-Cell Laboratories, is part of their Hydrox-C line of advanced skin care. The Rapid Restoration Patch is a quick-release, non-adhesive, dermal transfer patch for the area around the eyes, upper lip and smile ...
Medi-Cell Laboratories, Inc. is the first and only company to combine three different types of Vitamin C with Alpha Hydroxy Acid in non-irritating formulations.
Karl Note: The full text here requires a premium membership to access. Presumably this substance is classified as a "drug" and is apparently transdermal.
It appears that "drug companies" could and would research "vitamins" which would not be eligible for patents if marketed under the DHSEA but they would rather do enough research on the to allow them to be classified as "drugs" and get the patent that gives them the monopoly. It is very likely that a "substance" such as MSM with Vitamin C, in a cream form, could do much of what this drug might do -- but be covered under the DHSEA.
It is a "catch 22!" If you spend the money to get a substance classified as a "drug" you can make the claims for affecting function or structure. If you prefer to market the SAME product as a "non-drug," under the DHSEA, you could easily get into trouble making the same claims. In fact you would have to find ways to market without making health claims.
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VitaMan ® Give Me Strength!
A Drug-Free Alternative to Viagra ® by Pfizer
VitaMan ® has been fortified with several new ingredients and with greater strength to meet the needs of today's active man. Research into vitamin supplementation with certain vitamins and minerals has shown a direct benefit in helping to restore energy levels and eliminate any "Marginal Nutrient Deficiency" which may be affecting his ability to generate his maximum personal peak of performance in work, sports or sex.
You may wish to choose VitaMan ® as a readily available drug-free alternative to Viagra ® by Pfizer for prescription-only treatment of erectile dysfunction, if your problem stems from the simpler and more common "Marginal Nutrient Deficiency" experienced from time-to-time by large segments of the male population.
This MultiVitamin formula, in addition to zinc, vitamin E and the inclusion of Royal Jelly Complex from bee pollen, provides calcium, phosphorous, manganese, pyridoxine HCL (vitamin B6), Niacin (vitamin B3), thiamine (vitamin B1), riboflavin (vitamin B2), cyanocobalamin (vitamin B12) and folic acid.
VitaMan ® is not an aphrodisiac, but rather a sound nutritional supplementation approach to a man's basic energy needs
Karl Note: This looks like the common method that non-drug substances are marketed -- offering to be a "non-drug alternative to 'xxx'."
This approach would suggest that AyurCream be "positioned" as a non-drug, non-cosmetic, which is the "non-drug" alternative to xxxx."
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Karl Note: If a substance, such as a MSM cream (not yet claimed by the FDA to be a cosmetic) is "colored," it might then be promoted as a "skin blemish cover," and be considered a "drug."
If the color is never claimed to be a "cover" then no medical claim is being made. It should be quite apparent that the ingredients or the substance of some product is generally less important than the claims made about it.
Yet, marketing and promotion is all about claims and benefits.
The "drug" and the "cosmetic" people have painted the vitamin people into a small corner of a big room where they expect to play and sell.
It may well be that one successful marketing strategy is to "position" a product as the "non-cosmetic," and "non-drug" alternative to some product.
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4. Vitamin E as a "drug" or "cosmetic" or "vitamin?"
| Dermatol Surg. 1999 Apr;25(4):311-5. | Related Articles, Links |
Karl Note: It is intriguing to consider that the above report can actually be HELPFUL to a firm markeing a cream, for instance, in which Vitamin E has been added, but where no claims are made for treatment or prevention of disease or to affect function or structure.
One could argue, then, that any "claims" made for the substance could even acknowledge that "this cream does not claim to treat or prevent a disease, nor does this cream claim to affect function or structure of the skin or any other part of the body. Nonetheless, it is well proven scientifically that "sulfur" is the most important nutrient for skin, hair and fingernails. The "delivery" of organic sulfur to the skin, in a transdermal formula, builds on the most basic science of health of the skin, hair and fingernails.
When that organic sulfur is complimented by other substances known and proven to supply the nourishment needed by skin, fingernails and hair, the cream can safely be marketed as a "non-drug" and "non-cosmetic" substance which, more basically than a drug, supplies ingredients directly to the skin -- ingredients known to be a part of the natural nourishment from food in which these ingredients are found.
It is also well-proven that defficiencies in food grown on today's mineral-deprived soils do NOT provide all of the ingredients understood to be useful nourishment.
One does NOT need a drug to treat or prevent a disease when food will do the same.
One does NOT need a cosmetic to improve the attractiveness of the body when food will do the same.
For thousands of years "FOODS" in the form of various herbs and vegetables have been used effectively to improve the level of nourishment for the body - a level of nourishment often lacking in sources of vegetables grown with chemical fertilizer on depleted soils.
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5. Sulfur: The most vital nutrient for skin health
| J Invest Dermatol. 1988 Jan;90(1):78-85. | Related Articles, Links |
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abstract:
Document Type: Research article
DOI: 10.1079/BJN19730060
Affiliations: 1: CSIRO, Division of Animal Physiology, Pastoral Research Laboratory, Armidale, NSW 2350, Australia 2: CSIRO, Division of Tropical Agronomy, Pastoral Research Laboratory, Townsville, Queensland, 4810, Australia
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6. Non-Drug Alternative To Ritalin
Hyperactivity, Attention Deficit Hyperactivity Disorder (ADHD)ADHD primarily effects children though it can involve adults. It is a condition of the central nervous system . Behavior and learning problems is the result.Studies have shown definitively that food allergies often play a large role in ADHD.
ADHD may include sleep disturbances, failure in school, inability to sit still, learning disabilities, easily frustrated, low stress tolerance, absentmindedness, forgetfulness, impatience, temper tantrums, mood swings, and self destructive behavior. All of these symptoms do not have to be present in all of the ADHD sufferers.The first line in holistic treatment is chiropractic evaluation.
Most ADHD individuals have a subluxation complex in the upper cervical spine which may involve the cranial area. A chiropractic technique that is well tolerated by children is the ACTIVATOR method.
Visit http://www.activator.com for more information on this technique.
This site also offers a free referral service to help you find an Activator practitioner in your area.A recently published report by two Mississippi State University researchers and chiropractor Robert Leach shows that chiropractic may be potential non-drug treatment for children with hyperactivity. Results of tests conducted during the researchers' pilot study showed significant improvement in hyperactive children following chiropractic treatment.
The paper appeared in the October, 1989 Journal of Manipulative and Physiological Therapeutics.Nutritional supplementation should include 1 CalMa Plus and 3 Minchex daily for children.......adults should complete a Nutritional Health Survey. The Nutritional Health Survey can benefit the child also....especially if a carbohydrate intolerance is involved.
Dietary considerations should exclude all sugar and simple carbohydrates. A ketogenic diet such as that advocated by Dr. Atkin's may be beneficial but include plenty of fresh vegetables. Diet information may be found in these books:
Dr. Atkin's New Diet Revolution-Dr. Robert C. Atkins
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Sranley W. Jacob MD - "In a double-blind study of MSMs impact ondegenerative arthritis, he found that patients who ingested 2,250mg of MSM a day for six weeks felt an improvement in their pain reduction by 82%, on average."
Ronald M. Lawrence MD - "I've been practicing medicine for 50 years, and in all those years I've never seen a substance like this" Lawrence says in The Journal of Anti-Aging Medicine a peer-reviewed scientific journal, published Lawrence's preliminary study results last July.
Arthritic cartilage has only one-third the level of sulfur concentration of normal cartilage - perhaps that is why MSM has been so effective in treating arthritis.
But researchers don't know for sure if MSM is beneficial for arthritis because of its sulfur content or because of its antiinflammatory and analgesic properties.
Unlike aspirin, which offers immediate pain relief "MSM takes three to four weeks before you have noticable changes Lawrence says, "except in rheumatioid patients - they have felt differences in just one day, and certainly bythree or four days." According to Jacob, Lawrence and Zucker's forthcoming book, MSM can be a natural remedy for: osteoarthritis,rheumatoid arthritis, fibromyalgia, tendonitis and bursitis, muscular soreness and athletic injuries, carpal tunnel syndrome, post - traumatic inflammation and pain, heartburn and hyperacidity, headaches and back pain, allergies."
Consumers worried about oral MSMs toxicity can be assured it's safe, according to Lawrence. "It's safer than water" he says. Patients at the Oregon Health Sciences University who have received oral MSM as part of their treatment show no toxic build-up, even after years of ingesting more than 2,000mg of MSM each day. The body may actually use what it needs, then flush out the excess sulfur within 12hours.