Leadership in Action
CHPA is working with Capitol Hill and the broader supplement community to develop policy proposals and work with leaders in Congress to update and modernize the dietary supplement regulatory framework.
Read CHPA President and CEO, Scott Melville's, guest article in Natural Products Insider on the underappreciated need for DSHEA modernization.
Industry Leader Joins CHPA’s Executive Team
CHPA appointed Duffy MacKay as Senior Vice President, Dietary Supplements. MacKay is a highly respected industry veteran with more than two decades of commercial and non-profit experience in nutrition research, dietary supplement regulation, policy development, and association leadership. He is leading CHPA’s cross-functional dietary supplements team, directing strategy, shaping policy, and collaborating with stakeholders to help protect and grow this important, expanding consumer health category on behalf of the CHPA membership.
CHPA’s Jay Sirois Chairs USP Convention's First Meeting of Dietary Supplements Sector
Chaired by CHPA’s Jay Sirois, Senior Director, Regulatory & Scientific Affairs, the Dietary Supplements Sector of the USP Convention held its kick-off meeting in March. The sector convenes Convention Member representatives from within the broader public health arena and engages USP members around priorities related to building trust in the quality of dietary supplements.
Throughout 2021, CHPA Submitted Comments on Issues that Impact the Dietary Supplements Industry
- In response to new research published in Clinical Toxicology on March 23, 2021, CHPA released a statement, to underscore the importance of calling out “bad actors” – companies in the dietary supplement industry selling dangerous, fraudulent products that pose significant public health risks. The study found nine illegal stimulants, including deterenol, in fraudulently marketed sports and weight loss supplements.
- CHPA submitted written testimony in opposition to New York Assembly Bill 431-B, which prohibits individuals under the age of 18 from buying dietary supplements and OTC drugs for weight loss.
- CHPA, and other leading dietary supplement trade associations, sent a letter to Senators Tammy Baldwin (D-Wisc.) and John Hoeven (R-N.D.) advocating for increased funding for FDA's Office of Dietary Supplement Programs due to the growing dietary supplements market.
Debate Over Mandatory Product Listing Continues at 2021 Dietary Supplements Regulatory Summit
CHPA participated in the sixth-annual, one-day virtual Dietary Supplements Regulatory Summit (DSRS). Cara Welch, PhD, acting director of FDA’s Office of Dietary Supplement Programs covered a wide range of topics and expressed FDA’s interest in mandatory product listing, a topic generating mixed responses within industry. CHPA President & CEO Scott Melville represented the association on an industry panel, sharing CHPA's support for mandatory product listing.
Consumer Medical Devices
FDA Issues Proposed Rule to Establish Regulatory Framework for
OTC Hearing Aids
Approximately 30 million Americans experience hearing loss; however, hearing aids today are only available by prescription, and data show that fewer than one-out-of-five people who have hearing loss use them. Access to OTC medical devices, such as hearing aids, could help them overcome mild to moderate hearing impairment, improving access and consumers’ quality of life without a prescription.
In October, FDA initiated the rulemaking process to establish applicable requirements for OTC hearing aids. CHPA and our members had strongly encouraged FDA to act, and supported President Biden’s Executive Order (EO) in July 2021 that included a provision allowing hearing aids to be sold over-the-counter.
CHPA is reviewing the proposed rule to provide feedback to the Agency with our consumer healthcare industry perspective.
CHPA Spurs FDA’s Creation
of New Website for
OTC Medical Devices
On August 25, 2021, FDA’s Center for Devices and Radiological Health (CDRH) announced its new website, “Over-the-Counter (OTC) Medical Devices: Considerations for Device Manufacturers,” designed to assist manufacturers who are seeking approval or clearance of devices sold directly to consumers.
The CHPA Consumer Medical Devices (CMD) Committee had requested the Agency centralize information related to OTC medical device development. To facilitate development of the website, the CMD Committee proposed the initial list of questions and answers which served as the foundation for the website. The FAQs are intended to aid innovation programs for CMDs.
Visit the FDA website for details.