Four FDA officials along with a high-ranking Federal Trade Commission (FTC) expert spoke to nearly 150 attendees at CRN’s first ever Regulatory Summit on May 5 in Bethesda, Maryland, just outside Washington, D.C. Steven Tave, acting director of the newly-designated FDA Office of Dietary Supplement Programs (ODSP), underscored the importance of the elevation of dietary supplements from the “division” level to the “office” level at the agency, by giving dietary supplements a higher profile among regulators and acknowledging the tremendous growth of the industry. Read more...

Proposed legislation that would create unnecessary burdens for responsible companies manufacturing safe and beneficial products was withdrawn from consideration during a key Senate Armed Services Committee (SASC) last week. CRN had promptly issued an opposition statement in response to Sen. Richard Blumenthal’s (D-CT)announcement of his intention to offer an amendment... Read more...

CRN gave key member contacts a heads up on a new observational study that purports to raise concerns about folate levels in pregnant women and the risk of autism in their children. Entitled “Maternal Plasma Folate, Vitamin B12 Levels and Multivitamin Supplement during Pregnancy and Risk of Autism Spectrum Disorders in the Boston Birth Cohort,” it was presented in advance of receiving peer review as a conference paper on Friday. CRN posted a standby statement emphasizing the undisputed benefits of folic acid in preventing neural tube birth defects. In addition, CRN was pleased to see coverage from The Atlantic that called the study’s concerns “premature” and the press release about its findings “potentially dangerous” (authored by James Hamblin, M.D., a speaker at CRN’s Communications and Media Outreach Committee In-person Meeting last year).

CRN’s Communication and Media Outreach Committee's (CMOC) popular annual in-person meeting is coming up May 24 and 25 in New York City—there's still time to register, but don’t wait. Find out “what’s hot” from communications & marketing experts, gain key media insights from journalists, and more. See CRN's website for additional agenda details and registration: www.crnusa.org/CMOC-16 or contact Nancy Weindruch (202-204-7684).

Citing the USDA Organic framework as an appropriate example, CRN has recommended that the regulatory definition of “natural” should include a tiered system for labeling different categories of natural products. CRN made the recommendation in comments submitted to FDA on use of the term “natural” in the labeling of human food products—including supplements. CRN suggested FDA should consider the source of an ingredient as the key determinant of whether it meets the definition of the term “natural” for use in food labeling. If an ingredient is a derivative of a “raw” natural product, then that ingredient should still be considered natural for use in food labeling. In addition, CRN recommended that fortification of food in accordance with FDA’s Fortification Policy or pursuant to a standard of identity for enriched foods with essential nutrients, regardless of source, should be permitted in foods labeled as “natural.” See CRN in the News for more, or contact Duffy MacKay (202-204-7664).

FDA last week published its final guidance for industry “Frequently Asked Questions About Medical Foods: Second Edition.” According to FDA, this second edition, which finalizes the August 2013 draft guidance, provides responses to additional questions about the definition and labeling of medical foods, types of diseases and conditions that a medical food may be used to manage, and updates prior responses from the previous edition of the guidance. Read more in FDA’s Constituent Update.

The industry-wide dietary supplement registry now in development will establish a platform for further efforts, CRN’s Steve Mister explained during a recent hot-topic panel discussion, “Industry Self-Regulatory Efforts: Next Steps in Building Consumer Confidence,” at the Ingredient Marketplace conference and expo in Orlando, Florida. “While we know this registry alone will not solve all the problems in the industry, it is a necessary first step to help regulators, retailers and consumers define the universe of the reputable industry and be able to compare and evaluate products,” he said. Read more...

In addition to CRN’s national executive legislative fly-in event, CRN’s Day on the Hill, June 8, the association is holding a Day in Sacramento on May 24, to meet with California state legislators. CRN members with facilities and/or business interests in California are encouraged to attend. Please contact Ingrid Lebert (202-204-7699) as soon as possible to RSVP.

Prominent members of the Senate Health Education Labor and Pensions (HELP) Committee recently wrote to FDA requesting additional information on the agency’s use of draft guidances. The letter notes it has been two years since the senators began their investigation into the agency’s use of draft guidances to make substantive policy changes. A response from the senators’ initial inquiry revealed that the FDA had 172 draft guidances dated prior to Dec. 21, 2013, that were still pending as of March 9, 2015, and that the agency takes between 425 and 797 days to finalize a draft guidance. For instance, near and dear to the supplement industry is the original 2011 draft of the New Dietary Ingredient (NDI) notification guidance—an example of the agency attempting to make policy by guidance, and diverging from Congress’s intent in passing the Dietary Supplement Health and Education Act. Industry continues to await the release of the updated NDI guidance from FDA. For more information, contact Mike Greene (202-204-7690).

The U.S. Preventive Services Task Force (USPSTF) seeks comments on a draft recommendation statement and draft evidence review on folic acid supplementation for the prevention of neural tube defects. USPSTF acknowledges that evidence shows folic acid supplements reduce the risk of neural tube defects in developing babies. The draft recommendation statement and draft evidence review are available for review and public comment through June 6 on the USPSTF website. CRN will discuss comments with its Senior Scientific Advisory Council. For more information, contact Haiuyen Nguyen (202-204-7669).

CRN is pleased to announce that David Campbell of member company RB (Reckitt Benckiser) will again chair The Conference: CRN’s Annual Symposium for the Dietary Supplement Industry, taking place Oct. 26–29 at The Ritz-Carlton, Laguna Niguel, in Dana Point, California. The Conference will be held in tandem with The Workshop: CRN’s Day of Science. Four flexible registration options will be available—registration will open in June. Contact Gretchen Powers to receive a personal email when registration opens. Opportunities to sponsor CRN’s event are available for companies with a range of budgets—see the 2016 Sponsorship Prospectus for details.

“I think the case is significant because it specifically sends a message to FTC that across-the-board requirement of two RCTs is not going to fly in the courts.”

—CRN’s Steve Mister in Natural Products INSIDER, “Supreme Court Won’t Review POM, FTC Dispute”

What else did CRN have to say?

CRN’s Rend Al-Mondhiry highlighted the association’s self-regulatory initiatives on advertising during her presentation for a workshop held recently at Washington, D.C., law firm Crowell Moring. Ms. Al-Mondhiry spoke as part of a panel providing an overview of legal risks of associational advertising. Beyond CRN’s Code of Ethics, the association has a robust advertising review program with the National Advertising Division (NAD) of the Council of Better Business Bureaus and several sets of voluntary guidelines, she explained. Ms. Al-Mondhiry also noted that CRN is developing a voluntary product registry to enhance transparency and facilitate the exchange of information among various stakeholders that will be open to the entire industry and free at the basic level.

In case you missed recent newsletter items, CRN wanted to remind you of a few upcoming events, some with CRN members discounts and some complimentary:

• Free USP webinar May 19; USP offers CRN members discount on June 2 GMP
• IPA extends Probiota conference (May 31–June 2) discount to CRN members
• Covance co-hosting two free lunch events in June with CRN on New Analytical Tools to Protect Your Supply Chain

A two-day course, “Good Laboratory Practices for Food and Dietary Supplement Testing” designed and presented by CRN Associate Member company EAS Consulting Group along with Silliker-Merieux NutriSciences (parent company of CRN Associate Member Biofortis), will be held July 12–13. The course is ideal for those working in regulatory affairs, quality control/quality assurance, manufacturing, research & development, validation/qualification, as well as laboratory analysts, supervisors and managers, and will be of particular interest to those charged with implementing, validating and maintaining laboratory compliance programs. See the EAS website for details and registration.

Results from an analysis of UK Biobank data published in the Vol. 27 Supplement 1 of Osteoporosis International in April (highlighted on CRN’s Calcium Facts microsite) show use of calcium supplementation was not associated with increased risk of hospital admission or death following ischemic or non-ischemic cardiovascular events. These findings support the cardiovascular safety of calcium and vitamin D supplementation, at least within the age range studied, according to the authors. UK Biobank is a large prospective cohort comprising 502,664 men and women aged 40–69 years, with detailed assessment at baseline. Supplementation with calcium and/or vitamin D was self-reported, and information on incident hospital admission for ischemic heart disease, any cardiovascular event and death following these events, was obtained through linkage to Hospital Episode Statistics with follow-up of up to seven years. The analysis controlled for age, BMI, smoking, alcohol, educational level, physical activity, and in a further model, hormone replacement therapy in the women. See study abstract for more information.

See CRN's Research Watch for additional studies.

CRN Associate Member Informa Exhibitions invites companies to set up their own SupplySide Storefront in its new online environment where ingredient buyers and product developers can find and connect with the suppliers and solutions they need all year long. The virtual storefronts allow for the tens of thousands of buyers who are looking for ingredients, suppliers and solutions to find and connect with suppliers by requesting quotes, visiting their websites, downloading whitepapers, and viewing ingredients and solutions. Think of each supplier’s SupplySide Storefront as you would think of a booth at SupplySide West—a place where you can find the ingredients and solutions to bring your next great product to life. Find out more.

CRN’s CMOC In-person meeting takes place this month and more...

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

MAY 24
CRN’s Day in California
Sacramento, CA
—Lebert

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

MAY 25
CRN’s Government Relations Committee Teleconference
Washington, DC
—Greene, Lebert, Wroblewski

MAY 31–JUNE 2
Probiota Americas
Chicago, IL
—Wong

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

SEE FULL CALENDAR