Regulatory

H1N1, the influenza virus formerly known as Swine Flu, has made its way around the globe, leaving a trail of frightened consumers. They want to know how to protect themselves and their families-and whether there are any products they can buy to help.

Danone Withdraws Application for EU Health ClaimDSM Launches Ingredient Targeted at Lactose Intolerance

The Food and Drug Administration that we know, love, and on occasion love to hate, may soon be a memory. The winds of change are blowing toward Rockville, and the agency may never be the same.

Of all the foods in all the world, who would have guessed that peanuts would be the cause of a national food safety shiver that in all likelihood will change how FDA does business?

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

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.