Regulatory

InterHealth Nutraceuticals (Benicia, CA) has received its ISO 9001:2000 certification, the company announced on November 14.An ISO certification provides assurance on good management practice by an independent body.\"Our customers see a real benefit in the quality of our products and services and ability to respond efficiently to their need,\" said Paul Dijkstra, InterHealth CEO.InterHealth\'s ingredients are used in over 600 nutritional supplements, functional foods and beverages distributed in more than 30 countries worldwide.

Cognis Nutrition & Health received good manufacturing practices (GMPs) registration for its Covtiol vitamin E, Vegapure phytosterol, and Tonalin conjugated linoleic acid ingredients, the company announced on August 4. NSF International (Ann Arbor, MI) awarded the certification to Cognis’ production facilities in Kankakee, IL, and Illertissen, Germany, after conducting an intensive plant audit. NSF also will conduct periodic audits in the future.

Australia’s Therapeutic Goods Administration (TGA) has certified Capsugel’s (Greenwood, SC) Licaps liquid-fill production facility meets its regulatory requirements, the company announced on August 7.“The Australian GMP code is very thorough because it covers all medicines and is highly respected by many regulatory authorities around the world,” said Robert Whitelaw, director of sales, marketing, and business development for Capsugel’s Americas region.

Vitamins and minerals have nuanced effects that may vary depending on the study population.

You're excited, and elated. Clinical trials have proven conclusively that your new product works . It's like being in love-you want to shout it from the rooftops! You've developed a dietary supplement that will really help people with anemia, or arthritis, or obesity, or macular degeneration.

June 2008 was the deadline for large companies with more than 500 employees to comply with the final good manufacturing practices (GMPs) for dietary supplements. As the June 2009 and June 2010 deadlines for midsize and small companies loom closer, some manufacturers are still struggling to fulfill the rule's product-testing requirements. The April 2008 recall of two dietary supplement brands found to contain 200 times the amount of selenium listed on their labels highlights the fact that not every company is ready, willing, or able to hit the ground running.

FDA will issue a final rule next week in the Federal Register that describes official good manufacturing practices (GMPs) for dietary supplements. The rule is intended to ensure the quality of dietary supplements and prevent them from containing contaminated, impure, or adulterated materials.

  If one word could summarize the industry’s hopes and fears over the past 12 months, that word would be safety. A string of food scares in 2007 severely eroded public confidence in FDA. Meanwhile, a wave of negative media articles dented public confidence in dietary supplements and functional foods, two market segments that have been under increasing scrutiny.

  Food is critical for human existence. However, food goes beyond nourishment, as it encompasses a multitude of human experiences and emotions, and these vary between cultures and religions. More recently, food is being used and appreciated differently by women and men.

  When members of Congress hold a hearing, it’s usually not a sign of good news. However, when the House Subcommittee on Horticulture and Organic Agriculture convened on April 18 to discuss the status of USDA’s National Organic Program (NOP), it heard some very good news: organic products accounted for nearly 3% of all retail sales in 2005, pulling in just under $15 billion for the year.

  Food manufacturers that are looking for new opportunities might want to consider gluten-free products. On January 23, 2006, FDA proposed allowing voluntary labeling for the products, which lack proteins in wheat that can harm people with celiac disease-a chronic inflammatory disorder of the small intestine that affects up to 1% of the general population.

  Government officials, consumer advocates, and industry representatives debated how FDA should regulate functional foods at a public hearing held December 5.

 Weight-loss supplements have taken a drubbing in recent years from government officials, consumer groups, and the media. A key issue behind the controversy is the level of scientific substantiation for product claims. While researchers haven’t reached a consensus about the effectiveness and safety of most weight-loss products, many popular natural ingredients do have some supportive data, and the number of research studies generating useful information is growing.

Why is there a growing trend in the U.S. vitamin industry to purchase raw materials in China?

At the World Health Organization’s (WHO; Geneva) upcoming European Ministerial Conference on Counteracting Obesity, which will be held in November in Istanbul, Turkey, many of the world’s leading health experts will convene to develop new plans for dealing with the obesity epidemic. With any luck, functional foods will be one of the strategies that helps makes a difference.