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Articles from 2003 In April


Cancer Therapy: Eat An Orange?

Cancer Therapy: Eat An Orange?

Citrus pectin, found in the white, fleshy part of limes, lemons, oranges, and grapefruit, is a soluble fiber composed of mostly indigestible carbohydrates. However, citrus pectin exposed to alkaline conditions offers substantial promise for cancer therapy.

Modified citrus pectin is more water soluble and absorbable than its larger, unmodified parent. It takes on a stealth role against spreading tumors, cutting off the lines of communication between healthy cells and cancer cells. Studies of mice fed modified citrus pectin showed that the supplement reverses cancer cell growth. Only one human study has appeared to date. Researchers found five of 23 colon-cancer patients fed modified citrus pectin experienced stabilization of tumor growth over a period of two to six months, and one patient showed tumor reduction. Although the numbers are less than striking, additional studies are warranted to explore modified citrus pectin's effects over a longer period of time and on other cancers.

Nutrition and exercise biochemist Anthony Almada, MS. He has collaborated on more than 45 university-based studies, is cofounder of Experimental and Applied Sciences (EAS), and is founder and chief scientific officer of IMAGINutrition.




NNFA Opens D.C. Office

NEWPORT BEACH, Calif. (May 1, 2003) - In order to expand advocacy efforts with federal legislators and regulators on behalf of its members and the natural products industry, the National Nutritional Foods Association (NNFA) has opened an office in Washington, D.C.

David R. Seckman, NNFA's executive director and CEO, is the first of NNFA staff to relocate to the Washington, D.C. office, which will initially deal primarily with government relations and public affairs. NNFA also maintains an office in Newport Beach, Calif.

"NNFA needs to be on the frontlines to help protect and defend DSHEA [Dietary Supplement Health and Education Act] and other issues critical to the natural products industry," said Seckman. "Opening an office in Washington, D.C. is the first step in building a stronger presence here for the association. It gives us the opportunity for more frequent and personal contact with key legislators and decision makers. And, in light of the heightened legislative and regulatory activities regarding dietary supplements, the timing couldn't be better."

Seckman noted that less than half of the senators and representatives who supported DSHEA in 1994 are still in Congress. "One of our first tasks will be to educate those legislators who may not be aware of or understand the important role DSHEA played in improving the health of all Americans," he said.

NNFA's Washington office will be located in the downtown area at 1220 19th St. N.W., Suite 400, Washington, D.C., 20036.

The National Nutritional Foods Association (www.nnfa.org) is the nation's largest and oldest non-profit organization dedicated to the natural products industry. NNFA represents nearly 5,000 retailers, manufacturers, wholesalers and distributors of natural products including foods, dietary supplements, and health/beauty aids.

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Kemin Foods, Manufacturer Of FloraGLO Lutein, Lauds FDA's Proposed Good Manufacturing Practices (GMP) For Dietary Supplements

DES MOINES, Iowa (May 1, 2003) - Kemin Foods today announced its support for the U.S. Food and Drug Administration's new initiative to strengthen labeling, manufacturing and product quality requirements for the dietary supplement market.

"Ensuring that all products in our industry adhere to basic safety, labeling and product consistency standards will instill even greater confidence and trust among consumers," said Rodney L. Ausich, Ph.D., president of Kemin Foods. "That can only benefit our industry."

"Health and Human Services Secretary Thompson has stated that millions of Americans use dietary supplements and deserve to know they are getting the products they're paying for. I could not agree more," Ausich said.

Ausich said he sees the general GMP rule as achievable for companies already deploying rigorous research and production standards along with sound branding, labeling and consumer information protocols. "The GMP rule may result in somewhat of a shakeout within the industry, but the industry and those brands equipped to comply with the rule will be the better for it," he said.

"Our current manufacturing and quality assurance systems lead the industry in ensuring purity, potency and safety," said Ausich. "Our company's primary objective will be to shape our already stringent documentation and validation processes to the format necessary for GMP compliance."

Under the GMP proposed rule, manufacturers would be required to:

- Employ qualified employees and supervisors;
- Design and construct their physical plants in a manner to protect dietary ingredients and dietary supplements from becoming adulterated during manufacturing, packaging and holding;
- Use equipment and utensils that are of appropriate design, construction, and workmanship for the intended use;
- Establish and use a quality control unit and master manufacturing and batch production records;
- Hold and distribute materials used to manufacture, package and label dietary ingredients, dietary supplements and finished products under appropriate conditions of temperature, humidity, light and sanitation so that their quality is not affected;
- Keep a written record of each consumer product quality complaint related to GMPs; and
- Retain records for 3 years beyond the date of manufacture of the last batch of dietary ingredients or dietary supplements.*

Manufacturers are also responsible for determining that any representations or claims made about their products are substantiated by adequate evidence to show that they are not false or misleading.

About FloraGLO Lutein and Kemin Foods

Kemin Foods manufactures and markets FloraGLO brand lutein, a natural ingredient used in hundreds of vitamin and dietary supplement, food and beverage products around the world.

Nearly 300 published, peer-reviewed studies have documented the important health benefits of lutein for the eyes, skin and heart plus other health conditions. FloraGLO Lutein is the leading patent-protected, purified form of lutein on the market.

Kemin Foods, L.C. is a global manufacturer and marketer of natural ingredients for the food, dietary supplement and personal care markets. Headquartered in Des Moines, Iowa, USA, the company is part of Kemin Industries Inc., which has manufacturing facilities in Iowa, Texas, Belgium, India, Singapore and Thailand. To learn more about Kemin Foods and FloraGLO brand Lutein, visit www.FloraGLOlutein.com or www.luteininfo.com.

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U.S. Patent #5,382,714, #5,648,564, and #5,858,700; Japan Patent #2,790,212; Australia Patent #700,719; European Union patent #0672655; German patent # 69516031TZ; New Zealand Patent #319825.

* Source: FDA Fact Sheet ©¤ March 7, 2003

Alpha Packaging Introduces PET Capri Oval For Personal Care Products

St. Louis, MO – Alpha Packaging has introduced the Capri Oval, a proprietary polyethylene terephthalate (PET) package for the personal care market. The Capri Oval, available in a 250ml (8-oz.) size, is a graceful oval perfect for shampoos and conditioners, as well as lotions and liquids.

Alpha’s Capri Oval will be stocked in clear, white, dark green and cobalt PET. The Capri Oval is available with a 24-400, 24-410 and 24-415 neck finish to accommodate continuous thread closures, sprayers or pump dispensers. Alpha can provide a variety of appropriate closures for the Capri Ovals; closures are sold separately.

The Capri Oval is an attractive packaging alternative to more traditional round bottles. It is one of four new narrow mouth rounds Alpha has recently introduced for personal care manufacturers. With Alpha Packaging’s limitless color matching for PET, customers can match the color of their Capri Ovals to existing packaging for brand appeal. Custom colors are available in very short lead times, with relatively small minimum orders.

Alpha will begin stocking the Capri Oval in May, 2003. It is currently taking orders for both stock and custom colors, and samples are available now by calling Alpha’s sales customer service departments at 800-421-4772.

Alpha Packaging is a leading manufacturer of high density polyethylene (HDPE) and PET bottles and jars for the nutritional supplement, pharmaceutical and personal care markets. In addition to manufacturing, Alpha Packaging has tool-making capabilities, from unit body cavity molds to complete high-cavity production tooling. It also offers in-house design on CAD/CAM systems, serving as a strategic industrial design partner for customers in a variety of industries.

UK Food Standards Agency Report Examines Impact of Phytoestrogens on Health

Thursday, 01 May 2003m --A COT report (Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment) to the Food Standards Agency examines the implications of phytoestrogens in diet.

Phytoestrogens are natural compounds which mimic or block the physiological action of estrogen, and are found in many plants, including soya.

In this examination, the COT looked at whether phytoestrogens pose a risk to infants fed soya-based formulas, whether there are implications for other groups of people and whether there are benefits from eating phytoestrogens.

The group has recommended that the Department of Health review its advice on the use of soya-based infant formulas, and has concluded that phytoestrogens could adversely affect people with hypothyroidism.

Misbranded Dietary Supplements Destroyed

The Food and Drug Administration (FDA) announced today that Nature’s Youth, LLC, of Centerville, Mass., has completed its voluntarily destruction of approximately 5700 boxes (each containing a 30-day supply) of its misbranded product, “Nature’s Youth hGH.” This destruction, which occurred at locations in Massachusetts and Florida, was recently completed and involved approximately $515,000 worth of product. The firm also indicated it would change the labeling for future marketing of the product in or order to comply with the law.

FDA determined the product was misbranded after evaluating unsubstantiated structure and function claims made on the company’s website, as well as a review of the labeling of the product line. Among the false and misleading claims was that Nature’s Youth hGH was a “proprietary blend of amino acids and precursor nutrients which enhance the body’s natural production of Human Growth Factors and Insulin-like Growth Factor-1” that would, among other things, “improve physical performance, speed recovery from training, increase cardiac output, and increase immune functions.” The product also claimed to be “your body’s best defense against aging.”

“FDA is committed to help consumers make health and dietary choices based on accurate information,” said FDA Commissioner Mark McClellan, M.D., Ph.D. “FDA will continue to take strong action to protect American consumers from dietary supplements that are not accurately labeled or that make misleading claims unsupported by scientific evidence.”

FDA will continue to monitor the marketplace to ensure that products purporting to be dietary supplements are labeled properly and that claims being made for these types of products are not false or misleading.

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Clinical Study Shows Biocell Collagen II® Effective for Osteoarthritis

MIAMI, Fla., April 30, 2003 — A novel dietary supplement derived from sternum collagen improves the pain, stiffness, and quality of life in persons with osteoarthritis (OA), researchers announced today.

The findings of Dr. Eric Sheldon, a clinical research investigator at Miami Research Associates, are derived from a placebo-controlled pilot study in sixteen men and women with OA who received the supplement for an eight-week period. The supplement tested is a unique, patented extract of naturally occurring type II Collagen, Chondroitin Sulfate, and Hyaluronic Acid named BioCell Collagen II™.

“This preliminary study suggests that BioCell Collagen II has promise in the management of chronic OA symptoms,” said Sheldon, a rheumatologist and voluntary rheumatology instructor at the University of Miami School of Medicine. “We used a symptom assessment tool that is used routinely in OA drug studies and the results are encouraging.”

Sheldon said the data reveal that daily consumption of BioCell Collagen II led to clinically meaningful improvements that were significantly superior to the group receiving placebo supplements. Additionally, the BioCell Collagen II group had no greater incidence of adverse events or side effects.

Osteoarthritis, also known as degenerative joint diseases, is the most common form of arthritis. “We believe BioCell Collagen II is a viable alternative to glucosamine and chondroitin products, especially among those that have a concern or allergy associated with shellfish and cow-derived ingredients,” offered Suhail Ishaq, vice president of BioCell Technology in Newport Beach, CA. Glucosamine is derived from shellfish and chondroitin is typically derived from cow cartilage.

The study findings are being submitted for presentation at a national biomedical research conference scheduled for later in the year. The study was sponsored by BioCell Technology, LLC, Newport Beach, CA (www.biocelltechnology.com). It was conducted at Miami Research Associates (www.miamiresearch.com), a private clinical research center with over 25 years of experience in conducting clinical trial for pharmaceutical companies.

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Founded in 1997, BioCell Technology, LLC pioneered the applications of Sternum Collagen type II, the highest concentrated natural source available of type II collagen. It is the exclusive supplier of BioCell Collagen II™. BioCell Technology, LLC owns the exclusive rights to market BioCell Collagen II under the United States Patent #6,025,327. BioCell Collagen II™ is a branded trademarked logo that is available for display on its client’s labels to market under their own brand name or formulas. For more information on BioCell Collagen II, please contact the BioCell Technology sales office at (949) 476-3786, or visit them at www.biocelltechnology.com.

Vitamins + Underserved Children = Higher Grades

Teachers and Parents give Vitamin Relief USA™ High Marks for Improving
Children’s Academics, Attendance, Health, Behavior and Even Self Esteem

Murrieta, CA –Teacher Carol Thompson of Tom Elementary in Haworth, OK is just one of many teachers who had good news to report about Vitamin Relief USA™ in this year’s annual survey. She said, “I am a firm believer that the vitamin program has worked to improve student health as well as education. I didn’t realize something as simple as a vitamin program could produce such amazing results.”

Hundreds of parents also praised Vitamin Relief USA™. In fact, one out of every three parents surveyed stated that their children earned higher grades since taking daily multivitamins through Vitamin Relief USA™.

The good news didn’t stop there. Marked improvements in school attendance, behavior, energy, appetites, and self-image of the more than 1,350 children were also reported. 59% of parents said their children were eating better, while 48% reported their children were feeling better and were more active. School administrators were pleased that 42% of parents and 36% of teachers stated that children were sick less often, which resulted in higher school attendance.

“Though this is only an observational survey, the results are quite impressive. We are particularly pleased that the positive responses by parents, teachers and staff to this year’s survey are even greater than last year’s positive responses. In addition, we look forward to presenting next year the conclusive results of The Better Student Research Initiative™ which will substantiate the impact daily vitamins make on at-risk children and their academic performance,” says Michael Morton, Executive Director of The Healthy Foundation. In December 2002, Congress awarded The Healthy Foundation an earmarked appropriation of $500,000 to conduct a study to measure the impact of vitamin intake on at-risk youth and their school performance.

The Healthy Foundation provides daily vitamins to over 10,000 at-risk children at over 180 sites in 40 states. Its national initiative Vitamin Relief USA™ is a public/private partnership that distributes daily children’s chewable multivitamin/mineral supplements to children at risk for malnutrition and nutrient deficiency.

The Healthy Foundation is a tax-exempt, non-profit foundation committed to improving the health status of children and adults through vitamin supplementation. To support The Healthy Foundation or for further information, please call 877-935-5348 or log onto www.nourishamerica.org.

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Delicious Living

May 1, 2003

Health Claims Regulations Need Not Apply To Medical Foods

Because the US FDA currently has not issued final regulations for the medical foods category, legal expert Christopher A Brown says companies have the opportunity to shape those regulations and drive the market

Labels for foods—whether conventional foods such as milk, dietary supplements, such as vitamin C, or functional foods such as Benecol—may bear only so-called 'structure/function' claims to describe a food's health benefit unless the US Food and Drug Administration (FDA) authorises a health claim. However, there is one food category that may make health benefit claims on its labels without first having to obtain FDA approval. Such foods are called medical foods.

Medical foods, as defined by the Orphan Drug Act [21 U.S.C. § 360ee(b)(3)], are foods formulated to be consumed or administered enterally (taken by mouth or administered through a tube) under the supervision of a physician. They are also intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognised scientific principles, are established by medical evaluation.

FDA, in its proposed regulations [21 C.F.R. § 101.9(j)(8)], states that in order to qualify as a medical food, a product must be specially formulated and processed to provide nutritional support as part of an ongoing physician-supervised dietary management programme to treat a specific therapeutic or nutritional need.

Medical foods do not have to include nutrition information on their labels, and their claims do not need to meet specific standards. Currently, FDA is exploring ways to more specifically regulate medical foods. This might include mandating safety evaluations, specifying claims standards and requiring specific information on the labels.

Just because a medical food is available over the counter does not mean it is not used under a physician's supervision
Medical foods are often confused with foods for special dietary use, such as hypoallergenic foods. Medical foods are different in that they are intended to be used by people with specific dietary needs that arise due to a disease or condition, whereas foods for special dietary use are intended to be used by people with dietary needs for reasons other than a disease or condition.

Additionally, FDA, by regulation, exempts medical foods from its nutrient content claims and health claims regulations, as well as its dietary supplements labelling requirements; foods for special dietary use are not exempt. Therefore, manufacturers may make claims, without obtaining FDA approval, as to how a medical food addresses a patient's distinct nutritional requirements that exist because of a disease or condition.

Note that Federal Trade Commission rules still require that all advertising claims be truthful and not misleading. Thus, manufacturers must have on file competent and reliable scientific evidence that supports any health benefit claim that appears in advertising.

Although FDA has not issued any final rules governing medical foods, in 1996 FDA issued an advanced notice of proposed rulemaking (ANPR). The agency stated that medical foods are not meant to be used by the general public and may not be available in stores or supermarkets. FDA believes that, if medical foods were available over the counter, consumers who were not under the supervision of a physician would use them.

Furthermore, FDA stated that it believed Congress had intended foods for special dietary use to be a broader category of foods for people with special dietary needs or desires, whereas Congress intended medical foods to be a narrower category of foods for people with particular diseases or conditions who have distinctive nutritional requirements. FDA recognised that medical foods are targeted at diseased populations but that medical foods are not required to be pre-approved to ensure that they are safe and effective for those patients. Yet, since 1996, FDA has not finalised its rulemaking on medical foods.

In fact, FDA, other than defining medical foods, has not issued any final rules detailing specific requirements for product formulation and manufacturing, or set standards for claims, safety, efficacy and labelling. Therefore, FDA's views of medical foods are not law—the statutory and regulatory definition of medical foods is the only law governing this category.

Because medical foods are exempt from many FDA regulations, they have received little attention by FDA. Traditionally, most medical foods are liquids or mixes that have been available through hospitals and clinics and used for patients with specific medical needs. For example, burn patients' bodies consume a lot of extra nutrients during the time it takes to repair tissue damage. TraumaCal liquid, a specially formulated nutrient drink, is often given to burn patients to help ensure that those patients receive the optimal amount of nutrients they require for recovery.

However, the little attention given to medical foods by FDA has created an environment wherein manufacturers, taking advantage of an opportunity not to have to get FDA approval, have begun to market a variety of food products as medical foods—whether or not those products really qualify as such.

Opportunities lie in marketing low-risk products to low-risk populations
For example, Baker Norton Pharmaceu-ticals has marketed a medical food called Zbar, which is available over-the-counter and claimed to help maintain stable blood sugar levels overnight. It was not designed to treat people suffering from hypoglycaemia, but rather it was designed to help prevent it. Because FDA does not believe that medical foods should be sold in stores or supermarkets, FDA would likely not consider Zbar to be a medical food. However, Zbar could qualify as a medical food under the statutory definition of a medical food, because the statute requires only that a medical food be taken orally or enterally under the supervision of a physician for the dietary management of a disease—all of which Zbar could meet. Just because a medical food is available over-the-counter does not mean that it is not used under a physician's supervision. In fact, physicians often instruct patients to use particular over-the-counter drugs for indications in their labelling.

Zbar represents the conundrum facing the food industry. Many manufacturers are reluctant to enter the medical foods market because of the lack of definitive regulations. Manufacturers do not want to risk investing their time and money developing and marketing a medical food only to have the FDA issue final rules that could eliminate products from the market. On the other hand, many manufacturers see the lack of regulations as an opportunity to market products without FDA interference. The reality is that the current legal environment contains both risks and opportunities.

Additional risks lie in marketing high-risk products targeted to populations with life-threatening diseases. For example, marketing complete nutritional products to those in intensive care units brings with it the risk that a product that is sub- or super-potent may cause a potentially life-threatening hazard to a patient. If FDA does issue rules concerning formulation, safety and efficacy for medical foods, those rules will certainly apply to these types of products, and FDA will be more likely to take action against manufacturers.

Opportunities, on the other hand, lie in marketing low-risk products to low-risk populations. For example, physicians often instruct pregnant women to take a specially formulated multivitamin to help ensure foetal health. These multivitamins are often sold over the counter. Thus, if FDA were to finalise its rule wherein it believes that medical foods should not be available over the counter, the Agency could take action against marketers of such vitamins. However, because those vitamins are low risk and are not being marketed to anyone with a life-threatening condition, it is less likely that FDA would take enforcement action against manufacturers of those vitamins. In either example above, currently, both types of products could be legally marketed.

Therefore, the medical foods market, while a narrow market, is nonetheless one with opportunities for manufacturers of low-risk products that wish to make health benefit claims without obtaining FDA approval. Because FDA has yet to finalise any regulations governing medical foods, companies that are in the medical foods market for the time being have the opportunity to help shape those regulations and drive the market in the future.

Christopher A Brown is an attorney in Sonnenschein Nath & Rosenthal's food and drug practice group.
[email protected]