The US District Court for the Eastern District of Michigan, Southern Division, recently entered a consent decree that condemns and forfeits to the United States for destruction about $1.3 million worth of dietary supplements.

“The court order is the result of efforts by the federal government to protect consumers from products for which there is inadequate information to assure that they do not present a significant or unreasonable risk of illness or injury,” said Michael Chappell, FDA’s acting associate commissioner for regulatory affairs. “It shows that the agency is prepared to use the necessary legal means to keep such products out of the marketplace.”

At the request of the FDA, US Marshals seized more than 23,300 bottles of three dietary supplement products distributed by LG Sciences LLC (Brighton, MI). The seized products were marketed for use by body builders and distributed on the internet and in retail stores under the names Methyl 1-D, Methyl 1-D XL and Formadrol Extreme XL.

Based on laboratory tests, the FDA determined that the products contain one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to assure that the ingredients do not present a significant or unreasonable risk of illness or injury. Specifically, the condemned Methyl 1-D and Methyl 1-D XL contained 1,4,6-androstatriene-3,17-dione, also known as “ATD” or 1,4,6-etioallocholan-dione. The condemned Formadrol Extreme XL contained ATD and 3,6,17-androstenetrione (also known as “6-OXO”). Both of these substances are steroids that inhibit the activity of the enzyme aromatase and may be found in dietary supplements promoted to boost testosterone levels, the FDA said.

The FDA has no scientific information concerning the safety of the condemned products or their ingredients and, thus, cannot determine whether they represent a hazard to consumers. Under the circumstances, consumers who use or have used the products should discuss their use with their health care professionals.

The FDA also recommends that consumers consult their health care professionals if they have experienced any adverse events that they suspect are related to the products’ use. 

Dr. Michael Holick from the Boston University School of Medicine, who has revolutionized the understanding of vitamin D and its role in disease prevention,. received  this year’s $50,000 Linus Pauling Institute Prize for Health Research.

At a presentation at Oregon State University, Holick was recognized for his work to redefine vitamin D deficiency. He has also been strongly criticized over the last two decades for his stance that abstinence from direct sun exposure through sun block use was leading to increasing vitamin D deficiency—with serious implications for cancer and other diseases.

Holick was the first scientist to isolate the active forms of vitamin D, and in the past three decades has become the world authority on photobiology of vitamin D through synthesis in the skin. He has determined that anyone living north of 35 degrees latitude can’t make enough vitamin D in the skin during winter exposure to sunlight. His work has helped lead to vitamin D fortification in various foods.

“I well remember Linus Pauling standing up to criticism and skepticism, a trait of Holick as well,” said Nevin Scrimshaw, president of the International Nutrition Foundation, in nominating him for this award. “Today, Holick is recognized as a world renowned nutritional biochemist/physician whose research has had a global impact on the health of both children and adults.”

Product Animations, Inc. (PAI, Chicago, IL), a leader in virtual and interactive training for global manufacturing clients, recently announced a range of virtual reality (VR) Productivity Improvement/Training Tools designed to enhance the processing and manufacturing of pharmaceutical products.

One of the most popular tools is a customized operator-training program called VRTrain™.  Many of PAI’s customers have implemented VRTrain to assist in the training of manufacturing teams who are responsible for the day-to-day operation of equipment such as tablet presses, fluid beds, capsule filling equipment, labelers, thermoformers and cartoners. VRTrain is available for many commonly used pharmaceutical processing and packaging machines from numerous manufacturers, including Glatt, Vector, MG2, Fette, Bosch, Uhlmann, IMA, Pester, Oystar and more.

PAI’s Productivity Improvement/Training Tools provide ready guidance at the machine for operators and maintenance personnel as well as the ability to visualize processes through simulated real-world situations. Using VRTrain, machine operators and maintenance personnel learn by doing without the costly equipment downtime typically involved in training programs. VRTrain improves knowledge retention by providing a self-paced, hands-on learning environment for training.

Companies using VRTrain report reductions in training time and enhanced training consistency across multiple shifts and facilities while achieving reduced equipment downtime, improved productivity and performance efficiency. These intuitive tools offer a user-friendly, cost-efficient way to train operational personnel in global best practice.

Martek Biosciences Corporation (Columbia, MD) announced that it has entered into a multi-year, sole-source supply agreement with Lactalis Nutrition Sante for the use of life’sARA in infant formulas and growing-up milks produced by Lactalis and sold in France and Algeria.
 
“Our partnership with Lactalis further demonstrates that companies worldwide understand the importance of adding Martek’s ARA to infant formula for infant health and development,” said Ethan Leonard, vice president of pediatric nutrition for Martek. “Martek’s DHA and ARA can be found in infant formula sold in more than 75 countries, and we continue to expand our international presence in the infant formula market.”
 
Naturally present in human breast milk, ARA (arachidonic acid) is a fatty acid important to infant development and growth, said Martek. Clinical studies have demonstrated numerous benefits, including improved mental and visual development, for infants receiving formula supplemented with ARA and DHA (docosahexaenoic acid), another fatty acid important to infant development.

For more information, call (410) 740-0081 or visit www.martek.com.

According to the Associated Press, a UN-sponsored treaty to combat highly dangerous chemicals has been expanded beyond the original “dirty dozen” (which includes the widely banned pesticides DDT—aimed to be phased out completely by the early 2020s—and chlordane) to include nine more substances that are used in pesticides, flame retardants and other products, UN officials said.

A 160-nation meeting recently added the chemicals—labeled as posing a risk to people's health and the environment—to the list of the Stockholm Convention on Persistent Organic Pollutants, or POPs, which bans or restricts their use, according to a statement by the UN Environment Program.

The so-called POPs pose a risk to humans and the environment because they often damage reproductive health, can lead to mental health problems, cause cancer or impede normal growth, said Donald Cooper, executive secretary to the treaty.

“These chemicals transit boundaries. They are found everywhere in the world,” Cooper said. “They don’t go away. They persist in the atmosphere, they persist in the soil and in the water for extremely long periods of time. Once you have a small amount in your body, it doesn’t go away and you add another bit, and another bit and another bit, it keeps adding up and getting worse and worse.”

In its additions, the meeting decided to ban chlordecone, which was used as an agricultural pesticide; hexabromobiphenyl, an industrial chemical that was used as a flame retardant; and lindane, which has been used in insecticides for soil, wood and animals, AP reported. The meeting also decided to restrict the use, production and trade of so-called PFOS, a toxic chemical used in many electronic applications, such as semiconductor chips.

With continual declines in the economy coupled with near historic lows in farmer pay prices for conventional milk, Organic Valley Family of Farms (LaFarge, WI) is making efforts to safeguard its cooperative of more than 1,300 organic family farmers by pioneering a supply management system.
 
In lieu of cutting its own sustainable-based dairy farmer pay prices, Organic Valley will require its farmer-owners to reduce their organic milk supply by seven percent beginning on July 1.  
 
The mandatory supply reduction is a pioneering move within the organic dairy industry in which the cooperative is collectively reacting to economic difficulties without cutting pay prices or cooperative membership. Organic Valley also hopes the move will enable its farmer-owners to increase the quality of their milk by focusing more on top quality producing cows, increasing pasturing and decreasing grain feeding (as cows who pasture more in place of eating grain produce less.)
 
“Our competitors in the organic milk business are facing similar challenges and are meeting them with farmer pay cuts, artificially deflating their retail price at the expense of the farmer or dropping the farmer off the truck altogether,” said George Siemon, one of the founding farmers and chief executive officer of Organic Valley. “And, once a dairy company drops an organic farmer, the farmer is left without a market after the costly and lengthy commitment to become certified organic. With conventional milk at a record low, this could be devastating to the organic farmer left to choose between going back to conventional or to sell organic at an unsustainable price.”
 
Each farmer will have an opportunity to appeal the requirement, and his or her appeal will be taken under consideration by the farmers’ regional coordinators, as well as the Organic Valley board of directors, if necessary.
 
For more information, call (888) 444-MILK or visit www.organicvalley.coop.

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