The Short Report | Printable PDF
A topline report from the Council for Responsible Nutrition (CRN),
the leading trade association for the dietary supplement and functional food industry
Supplement OWL label upload process made easy
Retailers now have two new efficient and affordable options to upload their own store brands of dietary supplement labels into the Supplement OWL, the new online dietary supplement product registry. UL, the global independent safety science company responsible for developing and administering the Supplement OWL, and the Hamacher Resource Group (HRG), a partner in category management, business strategy, and marketing services, are now both offering to provide data entry of the label information for a nominal, per label fee.
Product marketers will still be involved in the process, including providing final approval before the labels are posted. However, these newly-announced services should reduce the time previously required and speed up the process. Marketers can provide their complete labels to the firm and it will identify and extract relevant data fields for entry into the Supplement OWL. CRN member companies will soon be required to participate in the Supplement OWL as a condition of membership, and it is anticipated that responsible dietary supplement marketers (including retailers with store brands) will also want t
o participate as the Supplement OWL gains traction to demonstrate their products’ equivalence in quality and transparency to premium brands.
To get started, contact UL or HRG.
ITC rejects effort to prohibit fish oil supplements but drug company plans appeal
Fish oil supplement manufacturers received good news from the International Trade Commission (ITC) recently as the Commission announced it would not investigate a complaint filed by Amarin Pharma in September, asking ITC to declare concentrated EPA omega-3 fish oil a “drug.” ITC’s decision declined Amarin’s request to institute an investigation into these products which could have prohibited importation of concentrated EPA omega-3 fish oil for dietary supplement products. ITC’s decision was a victory not only for legitimate manufacturers that sell legal fish oil supplements, but for consumers depending on accessible, affordable products that benefit their health and well-being. However, CRN learned this week that Amarin intends to appeal that ruling to the Federal Circuit.
Battling the Amarin complaint on the front lines since it was filed, CRN actively participated in the case on behalf of its members, filing two legal briefs with the Commission and strongly urging FDA to weigh in on the usurpation of its authority to determine what is a drug under federal law by the pharmaceutical company seeking a drug monopoly on the popular fish oil products. CRN praised FDA for issuing a stern letter of opposition which reinforced CRN’s argument that Amarin “crossed a legal boundary” by seeking to bypass FDA’s rightful authority to interpret federal food and drug laws to determine what is a drug and what is a dietary ingredient. Omega-3 fatty acid supplements are consumed by 16 percent of U.S. adults according to a recent survey by CRN.
FDA warns against SARMs in body building products, CRN expresses support
Retailers should pay attention to a recent cautionary press advisory and Warning Letters issued by FDA to three companies for distributing products that contain selective androgen receptor modulators (SARMs). FDA concluded the products are not dietary supplements, but rather unapproved new drugs that have not been reviewed for safety and effectiveness. In Warning Letters to Infantry Labs, Ironmag Labs, and Panther Sports Nutrition, FDA cautioned that SARMs may increase the risk of heart attack or stroke and life threatening reactions like liver damage, and called on the companies to promptly address these illegally marketed products.
CRN issued a joint press release with four other industry trade associations and the U.S. Anti-Doping Agency (USADA) supporting FDA’s efforts to crack down on companies unlawfully manufacturing products containing SARMs and encouraging consumers—particularly amateur and elite athletes—to educate themselves on the dangers that SARMs-tainted products pose and make smart purchasing choices.
What’s a Medical Food? CRN hosts Summit to explore budding wellness category
Therapeutic nutritional products labeled as “medical food” are gaining increased interest at retail, but what is this new category? Nearly 80 top company executives and stakeholders with an interest in the medical food industry gathered in Washington, D.C., last month to attend a Medical Food Summit, convened by CRN. The summit’s agenda examined the current FDA regulatory framework governing medical food and explored the scientific basis for these products along with growing consumer and healthcare practitioner demand for these products.
CRN’s Board of Directors is investigating whether to expand CRN’s mission and membership to include representation for companies manufacturing and marketing medical food. As consumer and retail interest in medical food grows, CRN is assessing whether representation of this industry can complement its work in the dietary supplement and functional food industries.
Know your #SupplementFacts
