On Wednesday, CRN members will join association staff and lobbyists in Washington, D.C., for “CRN’s Day on the Hill.” The day will be filled with face-time spent educating Members of Congress and their staff about the benefits of dietary supplements to their constituents’ wellness in addition to their local economies. Members will be armed with new data about the economic impact of the dietary supplement industry from a CRN-commissioned report to be released that day, and a brand-new government relations mobile app that will put CRN messages, key data about Congressional contacts, and much more, at their fingertips. Read more...

The annual CRN Communications and Media Outreach Committee (CMOC) in-person meeting in New York City saw its highest attendee count ever this year, with communications, public relations and marketing executives gathering to hear about the latest trends and best practices as well as insights from journalists and other stakeholders.

Among the presenters on the agenda was M.J. Wyatt, a consultant to CRN who is successfully garnering significant positive media attention about dietary supplements. Ms. Wyatt shared case studies illustrating the importance of how, in the current milieu of extreme transparency, what an organization says and does defines that organization. Read more...

FDA has recently published a final rule, a guidance, and a report, under the Food Safety Modernization Act (FSMA), all of which have potential impact for dietary ingredient and functional food manufacturers:

• FSMA Final Rule for Mitigation Strategies to Protect Food Against Intentional Adulteration  (a summary from CRN counsel Covington & Burling is available here)
• Draft Guidance for Qualified Facilities under the FSMA Preventive Controls Rules
• 5th Annual Reportable Food Registry Report

In addition, the agency has announced the long-awaited new Nutrition Facts Label. CRN provided its members with a preliminary summary and will report further as needed. The label features a refreshed design, reflects updated information about nutrition science and updates serving sizes and labeling requirements for certain package sizes. Most food manufacturers will be required to use the new label by July 26, 2018. Manufacturers with less than $10 million in annual food sales will have an additional year to comply with the new rules.

CRN’s Jim Griffiths and Andrea Wong will speak at free events on June 20 (Whippany, New Jersey) and June 23 (Ft. Lauderdale, Florida), respectively, held by CRN Associate Member Covance. The free educational agenda covering “New Analytical Tools to Protect Your Supply Chain” will include topics such as: the importance of analytical competence in today’s marketplace; using risk assessment for developing customized contaminant testing programs; and advanced screening—a new tool for detecting adulteration. Those interested in attending are encouraged to register by June 10.

A recent Q&A with Stephen Ostroff, M.D.—FDA’s new Deputy Commissioner for Foods and Veterinary Medicine (FVM)—confirms the agency is poised to strengthen its focus on dietary supplement regulation. Dr. Ostroff noted, “We recently took steps to enhance our work, including the creation of a separate office and recruiting new leadership. I think this will allow us to better work with and oversee the dietary supplements industry, which is rapidly growing and changing, and to be able to better use the regulatory tools that we already have at our disposal.” Read more on FDA’s website.

CRN strengthens its engagement opposing Puerto Rico Administrative Order 346 (AO 346) by retaining an in-commonwealth consultant, fluent in Spanish, to assist. AO 346 requires registration of all dietary supplements sold in the commonwealth as well as registration for manufacturers, wholesalers and retailers of the products—all without any legislative authority for the Order. Recent efforts by U.S. Rep. Ryan Zinke (R-MT) to introduce an amendment to the Puerto Rico Debt Relief legislation that would have prevented enforcement of Administrative Order 346 (AO 346) failed to get Congressional action. While, Rep. Zinke’s amendment to the debt relief bill was deemed not germane to the legislation, the House Committee on Natural Resources did agree to include a study to determine the economic effect of the proposal (AO 346), with findings due back to Congress by Dec. 31. CRN believes that the most effective way to address industry concerns in Puerto Rico will be to address concerns locally rather than through Congress. Read more...

CRN’s Ingrid Lebert along with representatives from CRN member companies doing business in California met with state legislators during the association’s “Day in Sacramento” on May 24. The CRN group emphasized the strong presence of dietary supplement industry in California, including its positive economic and health impacts. They highlighted the benefits, safety and quality of dietary supplements, the healthcare cost savings to the state when using specific dietary supplement regimens, and the importance of including multivitamins in low-income nutrition programs run by the state. For more information, contact Ingrid Lebert (202-204-7699).

Where can you hear from FDA and FTC officials, Attorneys General offices (and one Attorney General himself), renowned legal experts from some of the top firms, regulatory experts, and other key players in one event? The CRN/ACI Legal, Regulatory, and Compliance Forum on Dietary Supplements, taking place June 27–28 in New York City, with additional post-conference workshops on June 28 and 29, will not only provide “state-of-the-industry” updates, but also allow for the opportunity to discuss and assess the politics and policy shaping the industry’s current political, legislative, and regulatory atmosphere. The “who’s who” agenda is available on the American Conference Institute website, or in a printable PDF. CRN members can use the following code for a 10% discount off registration: P10-669-CRN16. For more information, contact Gretchen Powers (202-204-7682).

CRN’s Steve Mister and Jim Griffiths attended the U.S. Pharmacopeial Convention (USP) Dietary Supplement Stakeholder Forum face-to-face meeting on June 1, held to receive input on development of USP’s dietary supplement standards. The agenda covered such issues as USP’s upcoming dietary supplement adulteration database, DNA-based methods for botanical identification, residual solvents, monograph modernization, constituent overages, pesticide residues, dietary supplement nomenclature, gummy dosage forms, and probiotics. Dietary supplement industry executives, including Mr. Mister and Dr. Griffiths, voiced industry concerns related to USP monographs, general chapters and reference materials developed as tools for regulators and how responsible manufacturers are impacted by those standards. Industry stakeholders also raised the issue of the lack of food grade mineral ingredient monographs and third party verification/certification models to create a degree of equivalence. For more information, contact Jim Griffiths (202-204-7662).

CRN updated members on revisions to the California Office of Environmental Health Hazard Assessment’s Modified Proposed Rulemaking regarding Clear and Reasonable Warnings. A CRN summary outlines changes made in response to comments submitted by CRN and other stakeholders. CRN will join the Prop 65 Coalition comment letter currently being drafted by CalChamber in response and will determine whether to submit its own comments. See CRN’s Members Only website or contact Rend Al-Mondhiry for more information (202-204-7672).

“Cancer is serious so when an individual is afflicted with this disease it is important that the lines of communication be open to their physician or other health care providers. All of what a patient is taking needs to be communicated to their physician.”

—CRN’s Mike Greene in NutraIngredients.com, “McCaskill's push for FDA review of herb/chemotherapy interactions called an intrusion into doctor/patient relationship,” on an inquiry opened by Sen. Claire McCaskill (D-MO) noting these matters are best handled as part of a doctor/patient relationship and should not be the purview of regulators

What else did CRN have to say?

Learn what constitutes a Quality Agreement and how to establish one with your contractor during a free June 9 webinar, Quality Agreements in the Complex World of Dietary Supplements, offered by CRN Associate Member EAS Consulting. Understanding the role of a company’s quality unit and the importance of quality responsibilities being clearly defined and assigned to appropriate personnel is key to compliance with dietary supplement good manufacturing practices (GMPs). See the EAS website for details and registration.

A randomized control trial (RCT) published recently in the journal Nutrition assessed the effects of supplementation with curcumin over an eight-week period. Data indicated that curcumin was associated with a significant increase in serum adiponectin levels, and a reduction in serum leptin concentrations. These beneficial effects of curcumin remained significant after adjustment for changes in serum lipids and glucose concentrations, and baseline differences in BMI and serum levels of glucose and HbA1c as potential confounders of treatment response. See study abstract for more information.

See CRN's Research Watch for additional studies.

CRN’s Jim Griffiths attended the Annual General Meeting of the International Alliance of Dietary/Food Supplement Associations (IADSA) last month. He had the opportunity to spotlight CRN’s product registry project and noted that the preview was well received by international stakeholders. Presentations from the meeting are available on the International Trade and Market Development committee information center on the Members Only website. For more information, contact Jim Griffiths (202-204-7662).

CRN’s Day on the Hill—and more—taking place this month...

JUNE 7
CRN Executive Committee Meeting
Washington, DC
—CRN Staff

JUNE 8
ODS Dietary Supplement Research Practicum
Bethesda, MD
—Mister (presenting)

JUNE 8
CRN’s Day on the Hill
Washington, DC
—CRN Staff

JUNE 9
CRN Board of Directors Meeting
Washington, DC
—CRN Staff

JUNE 10
Retailer Meeting with Rite-Aid
Harrisburg, PA
—Mister

JUNE 13–11
NBJ Summit
Dana Point, CA
—Mister; Hyland

JUNE 14
ABA Section of Litigation Food & Supplements Sixth Annual Workshop
Purchase, NY
—Al-Mondhiry (presenting)

JUNE 17
Prospective Member Meetings California
—Hyland; Mister

JUNE 20
Covance/CRN seminar: New Analytical Tools to Protect Your Supply Chain
Whippany, NJ
—Griffiths (presenting)

JUNE 21–23
NAAG Summer Meeting
Burlington, VT
—Al-Mondhiry

JUNE 21
Retailer Meetings with WalMart and Sam’s Club
Bentonville, AR
—Mister

JUNE 22
Retailer Meeting with Walgreens
Deerfield, IL
—Mister

JUNE 23
Covance/CRN seminar: New Analytical Tools to Protect Your Supply Chain
Ft. Lauderdale, FL
—Wong (presenting)

JUNE 27–29
CRN/ACI Legal & Regulatory Conference
New York City
—CRN Staff

SEE FULL CALENDAR