Regulatory

FDA (Rockville, MD) announced in today\'s Federal Register the release of its final draft of \"Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act,\" according to the American Herbal Products Association (AHPA; Silver Spring, MD).

With the European Union’s (EU) upcoming nutrient profile regulations, BENEO-Group (Morris Plains, NJ) is reporting an increase in prospective clients. BENEO-Group anticipates advising many food producers on how to meet new EU criteria regarding improved labeling, packaging, and wording on food products.

The European Food Safety Authority (EFSA; Parma, Italy) has no displayed interest in drafting health claims for probiotics, according to accounts from EFSA’s June 15 health claims summit reported by NutraIngredients.com.One hundred and twenty representatives of the probiotics industry met in Brussels for a Q&A session which was the first opportunity for industry leaders to meet with EFSA since the organization enacted new health claims regulations three years ago.

Food producers in China are now operating under closer scrutiny due to new quality control and safety regulations, reports European Advisory Services (EAS; Brussels).

Cerilliant (Round Rock, TX), a producer and provider of certified reference standards and materials, announced the introduction of two new certified reference standards today, Rebaudioside A (Reb-A) and multi-component Rebaudioside-A Impurities.

Newswatch

Canadian Medical Schools Incorporating Alternative Medicine in Coursework Herbal Supplement Sales Experience Slight Increase

The European Food Safety Authority (EFSA; Parma, Italy) has published a Q&A in advance of its stakeholders meeting in Brussels on June 15 to help industry better understand its nutrition and health claims process.

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.

Company News

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.

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?