Participation in the Office of Dietary Supplements Dietary Supplement Label Database is responsible industry’s “civic duty,” but it is not enough, CRN President Steve Mister said in a presentation to the Board of Directors last week about the need for a more robust platform to achieve the association’s goals. Mr. Mister summarized results of the work of CRN’s Product Transparency Working Group over more than a year, explaining that CRN is uniquely qualified to lead this initiative and must act swiftly. CRN’s Duffy MacKay then presented additional details. Read more.

A segment on dietary supplement and prescription drug interactions ran on NBC Nightly News Friday night, March 18, as CRN had alerted members it would. The segment included advice from CRN that supplements can be healthy and that patients should discuss their dietary supplement use with their doctors.  

CRN reminded consumers that vitamin D and herbal supplements can play key roles in health and wellness, and that open communication between consumers and their health care providers about the dietary supplements they are taking is key, as it responded to four articles in recent JAMA publications. Following pre-embargo updates to CRN members, CRN issued a press release highlighting the link between vitamin D deficiency in pregnant women and the development of MS in their offspring. In addition, CRN issued a statement urging doctors to consider better ways to dialogue with their patients about herbal supplements they are taking. CRN’s perspectives were included in consumer press coverage about vitamin D—both the MS story and a story on knee osteoarthritis—and in trade press coverage of JAMA’s Patient Page on herbal supplements. Read more in CRN in the News.

The Wall Street Journal printed a letter-to-the-editor from CRN’s Duffy MacKay in the print and online editions, responding to a recent article on supplement and drug interactions. Dr. MacKay emphasized the importance of patients being open with their doctors about what they are taking. “...[T]he greatest risk isn’t the supplements; it’s being neglectful by not sharing the information,” he noted. See more on CRN’s Members-Only website.

Consumers are learning more about the benefits of dietary supplements through articles in popular publications in print and online, thanks to CRN’s retained consultant Wyatt Communications. Find links to samples of Wyatt’s placements on CRN’s behalf on CRN’s Members-Only website. As a reminder, if you learn of new scientific studies related to dietary ingredients—preferably prior to their publication—please give CRN a heads up and we’ll have Wyatt help to publicize those studies.  Contact Judy Blatman for more information (jblatman@crnusa.org / 202-204-7682).

As part of its Alliance Building initiative, CRN was a sponsor at FoodFluence 2016, an invitation-only networking and educational conference for 30 influential registered dietitians. CRN’s Duffy MacKay and Judy Blatman presented at FoodFluence, as well. CRN has already been called on as a resource several times from connections made at the conference and has had the opportunity to share science-based information about dietary supplements to this key audience of influencers. See CRN’s Members-Only website for more information, including a post-conference report on results of CRN’s participation in FoodFluence 2016.

The popular CRN Communications & Media Outreach Committee (CMOC) annual in-person meeting in New York City, May 24 and 25, is a great opportunity to learn about top trends and best practices from communications and marketing experts as well as gain insights from journalists on their coverage of dietary supplements. All CRN members are welcome to attend. Find out more and register today.

“This study demonstrates the potential benefit of vitamin D for patients with knee osteoarthritis as patients supplementing with vitamin D experienced pain reduction and a slightly smaller loss of cartilage over time...Even though the numbers are not statistically significant, these are positive trends that should encourage further research.”

— CRN’s Andrea Wong in HealthDay’s coverage of a study published in the March 8 issue of JAMA, also appearing in coverage from WebMD.com, Philly.com, Austin American-Statesman Online, Houston Northwest Medical Center, Doctors Lounge, Health Finder, Medline Plus, and UPI. A Fox News affiliate also noted CRN’s statement in its coverage of the study.

What else did CRN have to say?

Four prominent FDA officials, including Robert Durkin, acting deputy director of the newly designated Office of Dietary Supplement Programs (ODSP), are confirmed speakers for CRN’s inaugural Regulatory Summit, taking place Thursday, May 5, at the Hyatt Regency, Bethesda, Maryland. Find out more and register today.

FDA is in the “later stages” of preparing the revised New Dietary Ingredient Notification draft guidelines, and hopes “to publish this document in the near future,” according to a letter from the agency’s acting commissioner for Legislation written in response to a query from Rep. Jason Chaffetz (R-UT). In the letter, FDA acknowledged there was “considerable misunderstanding about parts of the draft guidance” released in 2011. FDA emphasized that it will publish “a revised draft guidance, rather than a final guidance to provide...stakeholders with a further opportunity to comment.”

FDA last week issued warning letters to six companies regarding six products for which the product labeling lists Acacia rigidula (A. rigidula) as an ingredient. The agency considers Acacia rigidula to be a new dietary ingredient, not lawfully marketed as a dietary ingredient in the U.S. before October 15, 1994, and not submitted in a new dietary ingredient notification to FDA. Learn more in an agency update. CRN’s Duffy MacKay spoke with Natural Products INSIDER about the action saying there is no excuse for companies to market an NDI without filing the proper notification with FDA and urging FDA “to act now, like we did a year ago, to get these products off the market.”

FDA recently announced changes in leadership, with Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor set to leave the agency on June 1. Stephen Ostroff, M.D., will become the second deputy commissioner for Foods and Veterinary Medicine upon Mr. Taylor’s departure. Dr. Ostroff led FDA as acting commissioner until the recent confirmation of Dr. Robert Califf, M.D., as FDA commissioner. In the Center for Food Safety and Applied Nutrition (CFSAN), Ted Elkin is deputy director for Regulatory Affairs, with CFSAN Director Susan Mayne, Ph.D., having recused herself from overseeing supplements due to a conflict of interest. Steven Tave has been named acting director of the newly designated Office of Dietary Supplement Programs within CFSAN and Bob Durkin will serve as acting deputy director. During CRN’s Board of Directors meeting last week, Covington & Burling Partner Denise Esposito gave a presentation sharing recent developments at the agency and reminding companies to look to FDA’s press statement on the creation of the Office of Dietary Supplement Programs (ODSP) for tips about its enforcement priorities, which are focused on consumer safety.

Participate in NIST’s dietary supplement lab QA program—register by April 1

CRN encourages its members to apply for Exercise M (Spring 2016) of the National Institute of Standards and Technology/National Institutes of Health Office of Dietary Supplements Dietary Supplement Laboratory Quality Assurance Program (NIST/NIH DSQAP).The study requires participating labs to test one or more ingredients using various methods and assists NIST to evaluate, compare and refine testing methodologies. Read more on CRN’s Members-Only website. Registration for Exercise M is available online at NIST’s website.

As part of National Consumer Protection Week, earlier this month, Attorney General Loretta E. Lynch recorded a video discussing the U.S. Department of Justice’s (DOJ) work to protect the health and safety of consumers from unsafe dietary supplements. See more on the DOJ website. CRN’s Rend Al-Mondhiry spoke to Natural Products INSIDER about the video, noting that CRN appreciates the enforcement against bad actors but is disappointed that Ms. Lynch “failed to recognize responsible and legitimate industry and its role in keeping consumers healthy.” CRN applauded DOJ in November of 2015 for its role in enforcement actions against dietary supplement companies that were breaking the law and tarnishing the reputation of responsible industry.

CRN president to speak at ODS supplement practicum

CRN’s Steve Mister will speak on an industry panel on the afternoon of June 8 during the 2016 National Institutes of Health Office of Dietary Supplements (ODS) Mary Frances Picciano Dietary Supplement Research Practicum. The event takes place over three days, June 7–9 in Bethesda, Maryland. Those interested in attending the practicum must apply by April 4, see the ODS website for details and eligibility.

Join CRN Washington for legislative fly-in, the ‘Day on the Hill,’ June 8—RSVP today

Join CRN and your industry colleagues in Washington, D.C., to engage with Congressional offices and educate Members of Congress about the benefits of dietary supplements, the effects of legislative developments on the industry and the importance of dietary supplement products to their constituents' health and wellness, as well as the economy. Mark June 8 on your calendar and RSVP today to participate in CRN’s Day on the Hill. Find out more: www.crnusa.org/DOH-16.

National GMO legislation stalled

A bill to pre-empt state GMO-labeling laws, introduced by Senate Agriculture Committee Chairman Pat Roberts, last week failed to clear a procedural vote in the Senate. The Senate vote of 48-49 to limit debate on the bill fell short of the 60 votes needed. This development greatly increases the likelihood that Vermont’s GMO-labeling law will take effect, as planned this July. The Vermont law will exempt dietary supplements, but functional food will be required to label for GMOs. CRN supported the federal legislation, and had signed on to the support letter from the Coalition for Safe and Affordable Food. Contact Ingrid Lebert for more information (ilebert@crnusa.org / 202-204-7699).

Sen. Heinrich calls on FDA to fully utilize enforcement capability

Sen. Martin Heinrich (D-NM), a Congressional Dietary Supplement Caucus co-chair, recently wrote to newly appointed FDA Commissioner Robert Califf, M.D. In his letter, Sen. Heinrich urged FDA to implement all existing legal authorities to prevent marketing and manufacturing of illegal products that masquerade as dietary supplements. He noted the health benefits of legal dietary supplements used by millions of Americans.

CRN provides members summary of Prop 65 ‘Lead Agency Website’ regulation

CRN has prepared a summary of the California Office of Environmental Health Hazard Assessment (OEHHA) Lead Agency Website regulation, effective April 1, now available on CRN’s Members-Only website. On Jan. 25, OEHHA finalized a regulation to develop a “Lead Agency Website” that will provide information to the public regarding exposures from Proposition 65 (Prop65) listed chemicals. OEHHA intends for this website to be included in future Prop 65 warning statements after the language is finalized (still in the rulemaking stage). For more information, contact Rend Al-Mondhiry (202-204-7672).

Massachusetts bill will remain in limbo until June

Massachusetts HB 3471, legislation that would prohibit the sale of weight loss and muscle building supplements to minors, last week failed to pass out of committee by deadline, but then received an extension order until June 30. CRN strongly opposes to the bill, and has been aggressive in efforts to keep it from gaining traction: writing opposition letters, testifying before the Joint Committee on Public Health, meeting with legislators, building an opposition coalition and more. Despite the extension, CRN does not expect the bill to progress in this legislative session, but remains vigilant for any movement before June. In other Massachusetts news, “energy drink” legislation, HB 2023 that CRN also opposed, has been relegated to a “study” which effectively kills any chance for it to move forward. For more information, contact Ingrid Lebert (202-204-7699).

A report by the eight speakers from the CRN-International (CRN-I) symposium held November 2015 in Kronberg, Germany, calls on the Institute of Medicine and the Codex Alimentarius Commission to establish reference values for bioactives that promote health or contribute to a reduction in risk of non-communicable diseases. The article titled “Nutrient reference value: non-communicable disease endpoints—a conference report” published online ahead of print in the European Journal of Nutrition. See more on CRN-I’s website.

New Chinese regulations to take effect July 1, brief comment period open

The Chinese Food and Drug Administration (CFDA) has released new regulations for “Measures for the Registration and Filing of Health Food.” There is a short window of opportunity to submit comments and questions about the regulations—they go into effect on July 1 and CRN would like to submit comments by May 1. Of particular interest are newly issued regulations related to the Notification and Registration processes for Health Foods and dealing with maximum levels, the range of vitamin and mineral source ingredients permitted, and a requirement that products imported for the first time go through the Registration process instead of the Notification process. More information is available on CRN’s Members-Only website.

A study recently published in Nutrition Journal found that UC-II, a nutritional ingredient containing undenatured type II collagen derived from chicken sternum cartilage, significantly improved knee function in patients suffering from knee osteoarthritis (OA). Male and female volunteers, age 40–70, with moderate-to-severe OA by physical examination were randomized into three groups receiving a daily dose of UC-II (40 mg), glucosamine/chondroitin (1500 mg G & 1200 mg C), or placebo for a 180-day period. The primary endpoint was the change in total Western Ontario McMaster Universities Osteoarthritis Index (WOMAC). At day 180, the UC-II group demonstrated a significant reduction in overall WOMAC score compared to placebo and GC. Supplementation with UC-II also resulted in significant changes for all three WOMAC subscales: pain; stiffness; and physical function. See study abstract.

See CRN's Research Watch for more studies.

Uncover consumer demand in 2016 at Ingredient Marketplace

Understand what consumers are looking for and why—the key to developing products they buy. Join your industry colleagues in Orland, Florida, April 27–29 for Ingredient Marketplace, featuring an expanded show floor featuring the biggest ingredient suppliers in the industry. See First-time exhibitors innovating the market, learn what go-to-market strategies have proven to be successful, and enjoy exclusive access to primary research on consumer demand around some of the most popular ingredients and categories. For more details and to register, visit supplysideshow.com

CRN’s Jim Griffiths attends USP's Herbal Medicines Expert Committee Meeting March 29–31, GRC holds teleconference March 30, and more.

MARCH 29–31
USP Dietary Supplements – Herbal Medicines Expert Committee Meeting
Rockville, MD
—Griffiths

MARCH 30
Government Relations Committee Teleconference
Washington, DC
—Greene; Lebert; Wroblewski

APRIL 2–6
Experimental Biology / American Society of Nutrition Annual Meeting
San Diego, CA
—Griffiths; Wong

APRIL 9
State Law Resources Spring Meeting
Chicago, IL
—Lebert (presenting)

APRIL 12
CRN Communications and Media Outreach Committee In-person Meeting
Washington, DC
—Blatman

APRIL 13–15
State Government Affairs Council National Summit
Portland, OR
—Greene

APRIL 14
Dietary Supplement Caucus Educational Lunch Briefing
Washington, DC
—Mister; Lebert; Wroblewski

APRIL 16–19
NACDS Executive Conference
Palm Breach, FL
—Mister

APRIL 25–29
International Alliance of Dietary Supplement Associations (IADSA) Annual Meeting
Prague, CZ
—Griffiths (presenting)

APRIL 26–27
NTP Workshop: Addressing Challenges in the Assessment of Botanical Dietary Supplement Safety
Bethesda, MD
—MacKay; Wong

APRIL 27–29
Ingredient Marketplace
Orlando, FL
—Mister; Hyland

MAY 5
CRN Regulatory Summit
Bethesda, MD
—MacKay; Griffiths; Wong; Nguyen

MAY 10–12
Vitafoods Europe
Geneva, Switzerland
—Hyland

MAY 11–23
Democratic Attorneys General Association
Boston, MA
—Al-Mondhiry

MAY 23–25
National Association of Attorneys General Spring Consumer Protection Meeting
Washington, DC
—Al-Mondhiry

MAY 24–25
CRN Communications and Media Outreach Committee
In-Person Meeting
New York City
—Blatman; Powers; Weindruch; Eischen; Lewis

JUNE 1
USP Dietary Supplements Stakeholder Panel
Rockville, MD
—Griffiths

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

SEE FULL CALENDAR FOR 2016, WITH DATES BEING ADDED THROUGHOUT THE YEAR