Regulatory
CRN Questions Health Advocacy Group over Selenium Claims
July 14th 2009The Center for Science in the Public Interest (CSPI; Washington, DC) issued a press release on June 29 alleging that selenium intake may increase several health risks. These claims have motivated an adverse response from the Council for Responsible Nutrition (CRN; Washington, DC), which insists that the studies referenced by CSPI do not support such claims.
Three Manufacturers Fail to Meet GMP Standards; FDA Intervenes
July 14th 2009FDA has requested a court order be issued on Quality Formulation Laboratories, American Sports Nutrition Inc., Sports Nutrition International LLC (Paterson, NJ), and Mohamed S. Desoky, the overseer of operations at all three companies.
FDA Releases Final Guidance on Serious Adverse Event Reporting
July 14th 2009FDA (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).
BENEO-Group Sees Increase in Clients with New EU Regulations Approaching
July 7th 2009With 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.
EFSA Negates Future Health Claims for Probiotics
July 7th 2009The 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.
Cerilliant Introduces Certified Reference Standards for Stevia
July 1st 2009Cerilliant (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.
Advertising Claims: A Pandemic Outbreak
May 20th 2009H1N1, 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.
FTC Considers Updating Its Guides to Endorsements and Testimonials
March 1st 2009On 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.
Judge Orders Weight Loss Author to Pay More Than $37 Million
January 15th 2009A 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.”
Marketers of Thermalean, Lipodrene, and Spontane-ES Must Pay More Than $15 Million
January 15th 2009A 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 Completes Successful CGMP Audit
January 9th 2009Robinson 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.
NPA Advocates Strength of DSHEA
January 8th 2009Responding 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.