Presentation: Recent Trends in Class Action Litigation for Dietary Supplements
Jennifer M. Adams, Partner, Amin Talati Wasserman presented to the RAC. A recording is available here.
FDA-related updates
- FDA Commissioner
February 7th the Senate confirmed Dr. Robert Califf as FDA Commissioner by a narrow vote of 50-46. Dr. Califf is a cardiologist and clinical trials expert who has previously served as FDA Commissioner for a year under the Obama administration. CRN plans to reach out to Commissioner Califf’s office in the future.
- FDA resumes domestic inspections
Citing a decline in COVID-19 cases, FDA announced it is resuming domestic surveillance or routine inspections and continuing to conduct mission critical domestic and foreign inspections as well as use remote regulatory assessments when possible. The agency plans to resume prioritized foreign inspections in April. FDA will continue to announce routine inspections prior to arriving at a facility. For-cause inspections will not be announced.
- Vitamin B6 citizen petition
CRN developed draft comments in response to a citizen petition submitted by Emery Pharma requesting FDA to require warning statements on vitamin B6 dietary supplements and to also reclassify supplements with doses higher than 10 mg/day as drugs available by prescription only. CRN disagrees with these requests and believes the petition does not lay out a strong case to prompt FDA action. Please review the draft comments and provide feedback to Haiuyen Nguyen by March 15th
Upcoming: Proprietary Blends Best Practices
CRN's Proprietary Blends Task Force is close to completing Best Practices for Manufacturing and Marketing Dietary Supplements Containing Proprietary Blends. Once circulated, RAC members should review and provide feedback on the document by emailing Haiuyen Nguyen. Previously, the Task Force completed Regulatory Responsibilities for Manufacturing and Marketing Dietary Supplements Containing Proprietary Blends, which outlines the regulations pertaining to labeling and claims related to proprietary blends. Please contact Haiuyen Nguyen with any questions.
Join CRN's Delivery Form Safety Task Force
As a result of the conversation from the January RAC call surrounding industry practices for addressing possible choking hazards in children related to gummy dosage form, CRN will reconvene the Delivery Form Safety Task Force to engage in further discussion on this issue. If you wish to participate, please reach out to Andrea Wong or use our self-service portal to add yourself to the email distribution list.
As a reminder, CRN has developed a number of voluntary guidelines and best practices for members including Guidelines for Caffeine Containing Dietary Supplements and Best Practices for Probiotics. See a complete list here.
NAC Update
CRN filed an additional response to FDA’s November 2021 letter in January. CRN has heard a report that NAC raw material being imported as a dietary ingredient was detained by FDA. We have asked for additional information from the importer to further understand the scope of the problem and how it might affect CRN’s strategy regarding NAC. If additional information becomes available that we can share, we will update RAC. In the meantime, if members learn about additional challenges for NAC, such as retailers removing from sale or import issues, please feel free to share with Megan Olsen. All information on CRN’s NAC efforts can be found here.
Supplement OWL Update
Two new features recently became available in the Supplement OWL. Users may now bulk publish and unpublish entries. Contact Luke Huber for more information.