Non-Traditional "Substances" Covered Under DHSEA or Drug Regs

 

References:

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1. Vitamin C Technology

2. Non-Drug Alternative To Viagra

3. Colored Cosmetics

4. Vitamin E as a "drug" or "cosmetic" or "vitamin?"

5. Sulfur: The most vital nutrient for skin

6. Non-Drug Alternative To Ritalin

7. MSM in healthy cartilage

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1. Vitamin C Technology

Source

Medi-Cell Laboratories' Age Lift Series anti-aging products part of company's Hydrox-C line

Drug & Cosmetic Industry,  September, 1998  

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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2. A Non-Drug "Viagra"

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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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3. Colored Cosmetics

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Source

A discussion of the art and science of colored cosmetics can provide a fund of knowledge useful to the physician in tackling problems related to appearance and dermatologic disease.

The formulation and use of colored cosmetics is an area of dermatology where medicine, science, art, and appearance intermingle. This makes the study of colored cosmetics both challenging and fascinating. Colored cosmetics are of medical significance for their ability to function as camouflaging aids. Recognizing dermatoses that rarely may be related to the use of foundations also is important. The formulation and efficacy of colored cosmetics is grounded firmly in the science of cosmetic chemistry and skin physiology. Yet, colored cosmetics are valued for their appearance-enhancing capability and the intangible aspects of well-being that their use imparts.

A discussion of the art and science of colored cosmetics can provide a fund of knowledge useful to the physician in tackling problems related to appearance and dermatologic disease.

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?"

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Source

Dermatol Surg. 1999 Apr;25(4):311-5. Related Articles, Links
 
Comment in:
The effects of topical vitamin E on the cosmetic appearance of scars.

Baumann LS, Spencer J.

University of Miami Department of Dermatology and Cutaneous Surgery, Miami, Florida, USA.

BACKGROUND: Vitamin E is a generic term for a group of tocol and tocotrienol derivatives.
 
Since the discovery that vitamin E is the major lipid soluble antioxidant in skin, this substance has been tried for the treatment of almost every type of skin lesion imaginable.
Anecdotal reports claim that vitamin E speeds wound healing and improves the cosmetic outcome of burns and other wounds. Many lay people use vitamin E on a regular basis to improve the outcome of scars and several physicians recommend topical vitamin E after skin surgery or resurfacing.
OBJECTIVE: We attempted to determine whether topically applied vitamin E has any effect on the cosmetic appearance of scars as suggested by multiple anectodal reports.
METHODS: Fifteen patients who had undergone skin cancer removal surgery were enrolled in the study. All wounds were primarily closed in 2 layers. After the surgery, the patients were given two ointments each labeled A or B. A was Aquaphor, a regular emollient, and the B was Aquaphor mixed with vitamin E. The scars were randomly divided into parts A and B. Patients were asked to put the A ointment on part A and the B ointment on part B twice daily for 4 weeks. The study was double blinded. The physicians and the patients independently evaluated the scars for cosmetic appearance on Weeks 1, 4, and 12. The criteria was simply to recognize which side of the scar looked better if there was any difference. The patients' and the physicians' opinions were recorded. A third blinded investigator was shown photographs of the outcomes and their opinion was also noted.
RESULTS: The results of this study show that topically applied vitamin E does not help in improving the cosmetic appearance of scars and leads to a high incidence of contact dermatitis.
CONCLUSIONS: This study shows that there is no benefit to the cosmetic outcome of scars by applying vitamin E after skin surgery and that the application of topical vitamin E may actually be detrimental to the cosmetic appearance of a scar. In 90% of the cases in this study, topical vitamin E either had no effect on, or actually worsened, the cosmetic appearance of scars. Of the patients studied, 33% developed a contact dermatitis to the vitamin E. Therefore we conclude that use of topical vitamin E on surgical wounds should be discouraged.

Publication Types:
PMID: 10417589 [PubMed - indexed for MEDLINE]

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

Source

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J Invest Dermatol. 1988 Jan;90(1):78-85. Related Articles, Links

Electron probe analysis of human skin: element concentration profiles.

Warner RR, Myers MC, Taylor DA.

Procter and Gamble Co., Miami Valley Laboratories, Cincinnati, Ohio 45239-8707.

Concentration profiles for the major biological inorganic elements Na, P, S, Cl, and K were measured across human skin using electron probe analysis and analytical electron microscopy.
Determinations were made within the cytoplasm of individual cells. Uniform element concentrations were present throughout the viable tissue, whereas element pofiles in the stratum corneum were considerably diverse. Phosphorus was practically absent from the stratum corneum.

 

 
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Sulfur (per unit volume) continuously increased from the inner to the outer cell layers of the stratum corneum largely as a result of cytoplasmic water loss as cells migrate to the surface.
Potassium was essentially excluded from the inner stratum corneum. Very large gradients for K, Na, and Cl occurred from the middle of the stratum corneum to its outer surface; these gradients are likely the result of the inward diffusion of salts from sweat and could play a variety of physiological roles. The paucity of K and P within the inner stratum corneum suggests these important intracellular solutes (and perhaps others, including water) are recycled within the viable tissue, thus providing a virtual nutrient supply immediately underneath the stratum corneum. Alterations in this recirculation could have a regulatory function in the physiology of this tissue.

PMID: 3335792 [PubMed - indexed for MEDLINE]

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Source

abstract:

Faecal and urinary sulphur excretions of Merino sheep given fifty-one forage diets were measured in 205 balance experiments to derive estimates of the dietary requirements of Merino sheep for S.
Faecal S excretion varied with the S, organic matter and digestible organic matter intakes. Non-dietary faecal S excretion was estimated by regression analysis and was approximately 0·7 g S/kg organic-matter intake. Apparent S digestibility declined linearly with the reciprocal of dietary S content, and was predicted to be zero when the dietary S content was 0·81 g S/kg organic matter.
Both urinary S excretion and S retention varied with the digestible S and digestible organic-matter intakes. Endogenous urinary S excretion was taken to be the urinary S excretion when digestible S intake was zero, and the sheep was at zero energy balance. It was estimated by regression analysis to be 38 mg S/d.
The S and digestible S intakes necessary to maintain the fleece-free tissues in S equilibrium can be calculated from the equations derived in this study. An example is presented.

Document Type: Research article

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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

The full text is free.

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6. Non-Drug Alternative To Ritalin

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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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7.

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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.