CRN last week officially announced a new self-regulatory initiative to help regulators and retailers identify and evaluate dietary supplements—an industry-wide finished product registry to be launched by the end of the year. The product registry will initially serve the regulatory and retail communities, with the ultimate goal of demonstrating industry accountability to consumers as well. The registry will be developed and managed by a third-party vendor, and CRN plans to announce the results of that search later this spring. Read more...

CRN responded to a study published online last week in Drug Testing and Analysis, “Pharmaceutical doses of the banned stimulant oxilofrine found in dietary supplements sold in the USA,” noting that oxilofrine is not a legitimate dietary ingredient and that consumers should beware. “Oxilofrine, also referred to as methylsynephrine, has not met the legal requirements for demonstrating a reasonable expectation of safety, and thus it raises questions about the potential health risks to consumers who might use these products,” CRN President & CEO stated. Read more...

A summary of the report from the Council for Responsible Nutrition-International (CRN-I) 2015 symposium Nutrient reference value: non-communicable disease endpoints published in the European Journal of Nutrition is now available on the CRN-I website in the following languages: Arabic, Chinese, English, French, German, Japanese, Korean, Portuguese, Russian, Spanish. The report calls for authoritative scientific bodies to set standards for bioactive nutrients, noting there are real public health benefits to be realized from bioactive nutrients and consumers need clarity when it comes to targeting goals for intake of bioactives in food and dietary supplements.

CRN has learned the Department of Health in the Commonwealth of Puerto Rico Department recently issued an Administrative Order to establish public policy regarding the distribution of natural dietary supplements/nutritional supplements. The Administrative Order will require all such products to be registered with the Division of Drugs and Pharmacies in the commonwealth. A summary of information CRN has received is available on the association’s Members Only website. CRN is seeking to gather additional information on this issue and is calling on member company representatives and/or contacts to contact Jim Griffiths (jgriffiths@crnusa.org / 202-204-7662) to share intelligence or to discuss further and develop comments.

Sen. Pat Roberts (R-KS) earlier this month offered an amendment that would require greater transparency by FDA when the agency publishes regulatory guidance. The amendment to S 2700, the FDA and NIH Workforce Authorities Modernization Act, calls for FDA to explain why the interpretation or policy set forth in a guidance is being provided in that non-binding guidance instead of being established through rulemaking. It also requires FDA to identify each specific statutory provision or regulation being interpreted in the guidance or authorizing a policy decision described in the guidance. Read more...

Jeffrey Blumberg, Ph.D., FASN, and Zeynep Madak-Erdogan, Ph.D., received the Mary Swartz Rose Senior Investigator Award and the Mary Swartz Rose Young Investigator Award, respectively, at the American Society for Nutrition (ASN) Scientific Sessions and Annual Meeting held in conjunction with Experimental Biology 2016 in San Diego, California. The Mary Swartz Rose awards are jointly presented by ASN and CRN to recognize outstanding research in the field of bioactive compounds for human health. Find out more in CRN’s press release.

California’s Office of Environmental Health Hazard Assessment (OEHHA) new Prop 65 website is now operational at: www.p65warnings.ca.gov. In addition, OEHHA announced that it would extend the comment period on its proposed modified Clear and Reasonable Warning regulation to April 26; CRN’s Prop 65 Task Force is developing submit brief comments. See CRN’s Members Only website for more information, or contact Rend Al-Mondhiry (202-204-7672).

“To see an ingredient sold in the marketplace that is patently illegal is very concerning to us...The one thing we can do is putting some pressure on FDA to be more aggressive in the enforcement here. The FDA needs to enforce the law...Just because it’s not easy or convenient to prosecute doesn’t mean they shouldn’t be out there protecting public health...People hear about a study like this and it scares them away from the legitimate industry.”

—CRN’s Steve Mister in STAT News “Controversial stimulant is found in easy-to-buy supplements”

What else did CRN have to say?

• CRN submitted comments to the National Center for Complementary and Integrative Health (NCCIH) on its draft Strategic Plan for 2016–2021, noting that new methods that can evaluate the safety of botanical products and other natural products with complex chemistry are especially needed. CRN said NCCIH should seek to foster research that examines the contribution of vitamins and minerals to closing defined nutrient gaps in Americans’ diets.
  
  
• CRN strongly supports the continued use of carrageenan in organic foods, and maintaining the status quo for  this ingredient with regard to its inclusion in the national organics list, the association stated in comments on the USDA National Organic Standards Board sunset review process.
  
  
• CRN also submitted comments to FDA on gluten-free labeling of fermented or hydrolyzed foods.

Demonstrating increased attention to the meaning of “natural” claims, FTC recently announced that four companies that market skin care products, shampoos, and sunscreens online have agreed to settle charges that they falsely claimed that their products are “all natural” or “100% natural” despite the fact that they contain synthetic ingredients. FTC has issued a complaint against a fifth company for making similar claims. CRN has a Natural Labeling Task Force that is submitting comments to FDA on this issue. Contact Andrea Wong for more information (202-204-7660).

Scientists at FDA provided “proof-of-concept” for a technique that identifies the presence of potentially harmful contaminants in probiotics, the agency announced earlier this month. According to FDA, the technique eliminates a product’s beneficial bacteria and allows any potentially harmful contaminants in the product to grow unimpeded, allowing detection of potentially harmful contaminants using standard laboratory methods. The technique is described in a paper, “Development of Phage Lysin LysA2 for Use in Improved Purity Assays for Live Biotherapeutic Products,” published in the journal Viruses.

The U.S. Pharmacopeial Convention (USP), a CRN Associate Member company, is presenting a seminar on ensuring quality control (QC) operations are in compliance with the dietary supplement good manufacturing practice (GMP) requirements June 2 in Rockville, Maryland. The seminar will include discussion of the use and benefits of USP monographs, test procedures, reference standards, and general guidance for GMP compliance.  The course will also cover GMP compliance for QC laboratory operations, covering a broad range of topics including specifications for components and finished products, analytical instrument qualification and calibration, validation and verification of test procedures, and internal and third party laboratory audits. USP offers classroom and webcast access to the seminar. Find out more on USP’s website and receive an early bird discount on registration before April 30.

CRN has moved its member directory online as the association transitions to a new website, to be launched at the end of 2016. Replacing the print version CRN has published in recent years, the member directory that lists the executive contact and a brief description for each of CRN’s member companies is now available on CRN’s Members Only website. Members are encouraged to save their username and password and bookmark the directory for easy access. Read more...

Supplementation with L-citrulline, an amino acid, enhanced cycling time trial performance and reduced subjective feelings of post-exercise muscle soreness and fatigue, according to a randomized, placebo-controlled crossover study published recently in the Journal of the International Society of Sports Nutrition. Twenty-two trained male cyclists consumed 2.4 grams per day of L-citrulline or placebo orally for seven days. On the eighth day, they took the L-citrulline or placebo one hour prior to a 4-kilometer cycling time trial. Researchers evaluated the cyclists’ times taken to complete the trial, along with other markers such as the ratio of power output to maximum volume of oxygen used (VO2) and plasma nitrite/nitrate and amino acid levels. L-citrulline supplementation significantly increased plasma L-arginine levels and shortened completion time by 1.5 percent. See study abstract for more information.

See CRN's Research Watch for additional studies.

CRN’s Steve Mister at the NACDS Executive Conference, Jim Griffiths at IADSA in Prague, and more...

APRIL 16–19
National Association of Chain Drug Stores (NACDS) Executive Conference
Palm Beach, 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
Government Relations Committee Teleconference
—Greene; Lebert; Wroblewski

APRIL 27–29
Ingredient Marketplace
Orlando, FL
—Mister (presenting on April 29); Hyland; Eischen

MAY 4
Advertising for Associations Seminar
Washington, DC
—Al-Mondhiry

MAY 5
CRN Regulatory Summit
Bethesda, MD
—Mister; 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
—Mister;Blatman; Powers; Weindruch; Eischen; MacKay

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

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

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