The US Food and Drug Administration (FDA) is advising consumers not to purchase or consume Total Body Formula in the flavors of Tropical Orange and Peach Nectar, or Total Body Mega Formula in the Orange/Tangerine flavor. The liquid dietary supplement products may cause severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.

The Total Body Formula products are sold in 8-oz. and 32-oz. plastic bottles, the Total Body Mega Formula is sold in 32-oz. plastic bottles and both products are distributed by Total Body Essential Nutrition of Atlanta. The company is the sole distributor of the products and has voluntarily recalled Total Body Formula in the flavors of Tropical Orange and Peach Nectar and Total Body Mega Formula in Orange/Tangerine flavor.

The Florida Department of Health recently provided reports to the FDA on 23 individuals who experienced serious reactions to these products seven to 10 days after ingestion. In all cases, the reactions included significant hair loss, muscle cramps, diarrhea, joint pain and fatigue. The FDA subsequently learned and is investigating a report that some individuals in Tennessee using the same products have experienced similar reactions.

FDA laboratories are analyzing samples of the products to identify the cause of the reactions, including the possibility that the products contain excessive amounts of selenium, which is known to cause symptoms such as those described in the adverse events reported to the agency. Selenium, a trace mineral, is needed only in small amounts for good health.

The products have been distributed in Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia. The FDA is advising consumers in all states to avoid using the products immediately and to discard the products by placing them in a trash receptacle outside of the home.

Consumers who have been taking the products and have experienced adverse reactions should consult their health care professional. Consumers and health care professionals can also report adverse events to the FDA's MedWatch program at (800) FDA-1088 or online at www.fda.gov/medwatch/report.htm.

For more information, consumers can call the FDA's toll-free Food Safety Hotline at (888) SAFEFOOD.

A civil law suit filed in the Connecticut Superior Court by Ultimate Nutrition names Diamond Drinks, Inc., Suscon, Inc., and Anthony Cenimo, Jr., all of Williamsport, PA, and MetaBEV, Inc., and John Sbordone both of Stamford, CT as defendants in an action to recover damages.

The defendants were all involved in the development and manufacturing of a protein shake product for Ultimate Nutrition. The complaint alleges that the defendants all assured Ultimate Nutrition that the product would be stable, with a one-year shelf life. When numerous bottles of the pink product turned green within six months and developed a bitter flavor, Ultimate Nutrition requested that Diamond Drinks recall the product, cure the defect and rerun the batch. When that defendant never responded, Ultimate Nutrition withdrew the product from the market.

Ultimate Nutrition alleges that the defendants at all times held themselves out as being competent manufacturers that followed Good Manufacturing Practices (GMPs) in Manufacturing, Packing or Holding Human Food, as set out in 21 CFR 110.

However, Craig Larsen, counsel for John Sbordone and MetaBEV, Inc., has responded to Ultimate Nutrition’s claim that the defendants had a duty to ensure GMPs were followed in manufacturing this product by stating that "the product ... was a dietary supplement and, as a matter of fact and law, at the time of production of the beverage... there were no GMPs for dietary supplements, and thus it would be impossible for Metabev, Inc., or any defendant, to have such a duty."

Ultimate Nutrition’s regulatory counsel Marc Ullman pointed out that “the GMPs in manufacturing, packing or holding human food is the minimum standard that all food product (including dietary supplement) manufacturers are expected to follow. This has been the law for a very long time and it is incredible to me that any responsible manufacturer could suggest otherwise.”

In a reversal of its earlier stance, China's drug safety agency is ordering local authorities to tighten controls on production of heparin, a blood-thinner linked to 19 deaths in the US and hundreds of allergic reactions, according to a report by Elaine Kurtenbach for the Associated Press.

The State Food and Drug Administration issued the order in a notice, seen Friday, March 21, 2008 on its website, that requires heparin producers to obtain the raw chemicals used to make the drug from registered suppliers. Raw heparin suppliers, meanwhile, are required to improve their management and tests on their products, it said.

Earlier, the Chinese drug agency had insisted that ensuring the quality of exported chemicals like heparin was the responsibility of importers and importing countries.

Heparin is derived from a mucous obtained from pig intestines and other animal tissues, often processed by small, unregistered workshops.

Investigations following the reports of sometimes-fatal adverse reactions in the US, and of similar allergic reactions in Germany, prompted China's new crackdown on unlicensed production.

A week earlier, the US Food and Drug Administration identified the contaminant in heparin batches from a Chinese supplier to US pharmaceuticals company Baxter International Inc. as over sulfated chondroitin sulfate. Baxter recalled nearly all its US-sold heparin injections after some patients experienced extreme allergic reactions to the products. There have been similar recalls of Chinese-sourced heparin in Germany and Japan.

Drug safety officials said they have not confirmed yet if the contaminant, which chemically mimics heparin, caused the dangerous allergic reactions.

But both the US and Chinese drug agencies said they were investigating how the over sulfated chondroitin sulfate, which does not occur naturally, got into the heparin batches.

The heparin probe, coming just a year after the toxic chemical melamine was found in a pet food ingredient from China, has refocused attention on various problems with safety and quality of Chinese-made drugs, foods and other products.

China's drug agency has often failed to adequately regulate the country's medicine supplies, and an explosion of production capacity has resulted in numerous reports of adulterated, counterfeit and otherwise unsafe pharmaceuticals. Last year, China executed the drug agency's director for taking bribes to approve unqualified medicines.

China so far has not reported any adverse allergic reactions to heparin products used in the country. But the Chinese drug safety agency ordered heparin makers to closely monitor reactions to their products and immediately halt production and recall any products with safety problems.

Deerfield, IL-based Baxter International was buying its heparin through a Wisconsin-based producer, Scientific Protein Laboratories (SPL), which in turn owns a Chinese factory—Changzhou SPL—and buys additional raw heparin from other Chinese suppliers.

SPL said that the contamination occurred earlier in the supply chain.

Linnea (Locarno, Switzerland & Easton, PA) has announced that the US clinical study of 7-Hydroxymatairesinol (7-HMR) conducted by Medicus Research recently received a first place award at the Scripps Integrative Medicine 5th Annual Natural Supplements Conference. The study of 7-HMR and hot flashes has shown significant alleviation for women by cutting incidence of hot flashes by 53 percent in postmenopausal women.

Jay Udani, MD, and Mary Hardy, MD, from Medicus Research (Northridge, CA) led the pilot study. “We are honored to have been granted this award which recognizes the quality of this original clinical research on 7-HMR and validates the clinical importance of this type of therapeutic approach to address hot flashes in women,” said Udani.

HMRlignan™, the lignan product utilized in the study and manufactured by Linnea, is a naturally occurring plant lignan, HMR, from the Norway spruce (picea abies).

The pilot study, entitled “The effect of HMRlignan on mammalian lignan and estrogen metabolite levels in post-menopausal women: A randomized, double-blind, single dummy, parallel group, pilot study,” analyzed changes in enterolactone levels and estrogen metabolites following ingestion of the plant lignan hydroxymatairesinol (HMR) and found significant improvement in reported hot flashes by the study participants.

“We at Linnea recognize the importance of achieving first place accolades from the Scripps Center for Integrative Medicine for our research,” said Robin Ward, vice president for Linnea. “It is paramount for our industry to produce ingredients and supplements that are supported with evidence-based research.”

The 7-HMR research will be published in an upcoming edition of the Journal for Alternative and Complementary Medicine.

For more information, visit www.hmrlignan.com or call (888) 253-0044.

The Organic Consumers Association (OCA) and Dr. Bronner’s Magic Soaps (Escondido, CA) made a settlement offer to body care companies who they say have misbranded their products as “Organic” or “Organics.” The offer is an attempt to give leading body care brands a chance to resolve claims made earlier this month against them, without litigation.

Earlier this month, The OCA and Dr. Bronner’s Magic Soaps issued a series of cease and desist letters to body care companies which have allegedly misbranded their products as “organic” or “organics,” despite the fact that their cleansing ingredients are made from non-organic conventional and/or petrochemical material, preserved with petrochemical preservatives.

Companies that ignore the settlement offer will face a legal challenge by OCA and Dr. Bronner’s under California law. To help convince the mislabeled brands to act, they were provided a professionally conducted detailed survey of California organic body care consumers which found that these consumers expect products with organic branding and label call-outs to contain main ingredients based on organic, not conventional, agriculture, free of petroleum compounds.

In a cover letter sent with the contract offer, OCA national director Ronnie Cummins and Dr. Bronner’s president David Bronner wrote: “Through the ‘Coming Clean’ campaign, the OCA and supporting companies like Dr. Bronner’s tried for years to clean the situation up through various educational and advocacy efforts short of litigation. After five years of frustration, we have created the only situation we realize will effectively incentivize the necessary changes, and are fully prepared to litigate and publicize each step of such litigation. However, we look forward to resolving this situation short of actual litigation, and will publicly celebrate and move forward with any and all parties who agree contractually to the straightforward terms in the attached contract. Our intention remains to clean the situation up, and not to drag culprit brands through the mud longer than necessary.”

Several of the body care companies in question include Jason, Avalon Organics, Nature’s Gate and Kiss My Face.

In response, Paddy Spence, president of Nature’s Gate, has issued the following statement: “Nature’s Gate is committed to manufacturing safe and effective personal care products and would never knowingly include ingredients that are proven to cause human harm.  The FDA has reviewed levels of 1,4-dioxane in cosmetics and concluded that they do not present a hazard to consumers. Based on the information from the study conducted by the OCA, we are reviewing all Nature’s Gate Organics formulas to ensure their continued compliance with the best available scientific information and the interests of our customers.”

Sales of healthy hemp foods are skyrocketing, so much in fact that Winnipeg, MB Canada-based Manitoba Harvest Hemp Foods & Oils is in the process of expanding into a much larger state-of-the-art food manufacturing facility. The company has begun the process of moving their operations across the city to a new 20,000 square foot space that will increase its production capacity by at least 500 percent.

Manitoba Harvest plans to hire five more employees in 2008, and more in the future as it expands production to meet demand from rapidly growing domestic and international markets. The company is in the process of purchasing new processing and packaging equipment to be installed at the site. The leased facility will also provide an abundance of office, warehouse and shipping space, as well as a full-scale laboratory for in-house product quality testing. Manitoba Harvest has completed phase one by moving its offices and warehouse operations, and plans to have phase two and three (packaging and production) complete by the end of summer.

“For each of the past several years our sales have been growing at least 50 percent, so each year the production and shipping areas here at the obsolete site have been getting tighter and tighter,” said Martin Moravcik, co-founder and vice president of operations that oversees the production side of the company.

The facility offers many energy conservation and environmentally-friendly features including energy-efficient lighting, R20 insulation to lower heating and cooling costs, and energy-efficient HVAC heating and cooling systems, which are approved by the Manitoba Hydro Power Smart Program.

For more information, visit www.manitobaharvest.com or call (800) 665-HEMP.