Regulatory

A federal judge has ordered infomercial marketer Kevin Trudeau to pay more than $37 million for violating a 2004 stipulated order by misrepresenting the content of his book, “The Weight Loss Cure ‘They’ Don’t Want You to Know About.”

A federal district court has ordered the marketers of three dietary supplements to pay more than $15 million for deceiving consumers about the products’ safety and effectiveness. The court imposed the final monetary judgment and permanent prohibitions against the marketers in December 2008, after granting the FTC's (Washington, DC) motion for summary judgment last June.

Robinson Pharma Inc., (RPI; Santa Ana, CA) announced its completion of a surveillance audit for cGMP compliant manufacture of dietary supplements on January 9. The audit was performed by STR (Enfield, CT), a third party testing and auditing firm with a focus on quality systems and analysis.

Responding to recent statements regarding dietary supplement regulation, the Natural Products Association’s (NPA; Washington, DC) CEO, David Seckman, released this statement on January 8:“Increased scrutiny by professional sports leagues on steroid usage, which the NPA commends, has unfortunately also led to increased and unsubstantiated allegations that a "tainted" or mislabeled dietary supplement is to blame when an athlete tests positive for a banned substance.

Sabinsa’s (Piscataway, NJ) probiotic ingredient, LactoSpore, received GRAS status after a review of safety and toxicology data by an independent panel of scientists.

On November 21, FTC announced that it is seeking public comments on proposed revisions to the Guides Concerning the Use of Endorsements and Testimonials in Advertising. The proposed revisions are intended to ensure that testimonials describe typical consumer experiences. FTC will stop accepting public comments on January 30, 2009. Nutritional Outlook spoke with John Feldman, a partner at Reed Smith LLP (Washington, DC), about the proposed changes. Why is FTC considering making changes to the guides?

A $7 million settlement has been reached between Airborne Health Inc. (Minneapolis), Florida, and 31 other states, said Florida Attorney General Bill McCollum on December 16.

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.