Natural Products Insider – Regulatory Updates: Robinson Pharma Fish Oil Softgels Passes DSVP – May 19, 2011

May 19, 2011 By

May 6, 2011

SANTA ANA, Calif.—USP Dietary Supplement Verification Program (DSVP) verified Omega-3 30% Fish Oil Softgels from Robinson Pharma Inc., allowing the company to use the USP Verified Mark on the product label. USP issued the approval letter (DSVP Ref. No.: 1083100401) after it conducted audits of Robinson Pharma Inc.’s facility and quality systems, including a review of staff training, manufacturing operations, supply chain qualification for all ingredients used in the manufacture of the product, and stability studies for the product post manufacturing.

May 9, 2011

Supplement Firm Convicted for Steroids

BOISE, Idaho—A federal court has sentenced the Arizona-based Tribravus Enterprises, which also does business as IForce Nutrition in California, to a fine and probation for marketing products as dietary supplements, but which actually were unapproved drugs due to being adulterated with steroids. Chief U.S. District Judge B. Lynn Winmill sentenced Tribravus to three years probation and a $125,000 fine, (payable in installments, in addition to a $400 special assessment) and ordered future financial disclosures and a monitoring and testing protocol that includes testing of all products distributed by Tribravus /IForce for banned steroids.

According to the plea agreement, FDA found three products distributed by Tribravus / IForce as dietary supplements —17aPheraFLEX, Dymethazine and Methadrol—contained synthetic steroids: DMT or Madol and Superdrol. The charges were filed in Idaho because Tribravus delivered its products to an Idaho retail company for wider distribution.

May 11, 2011

Central America and Caribbean Officials Debate Food Regulation

SAN JOSE, Costa Rica—Regulators from several Central America and Caribbean countries, many of which are in the process of developing food supplement regulations, met in Costa Rica April 27 to discuss evolving food supplement regulation globally, regionally and nationally. The Central American and the Caribbean Workshop on Food Supplement Regulation, organized by the International Alliance of Dietary/Food Supplement Associations (IADSA),brought together officials from Costa Rica, El Salvador, Guatemala, Honduras, Jamaica, Mexico, Panama, Paraguay and the Central American Economic Integration System (SIECA), who debated regulatory issues such as the classification, definition and safety food supplements. Other aspects discussed at the workshop included science-based risk assessment for setting upper levels; communicating the benefits of supplements; ensuring quality of products, including Good Manufacturing Practices; and market access and control of food supplement products.

May 12, 2011

EFSA OK’s Wellmune WPG® as Novel Food

EAGAN, Minn.—The European Food Safety Authority (EFSA) Panel on Dietetic Products, Nutrition and Allergies approved Wellmune WGP® (from Biothera) as a novel food, making it the only yeast-derived beta glucan to receive the novel food designation and be permitted for use in foods, beverages and supplements in Europe, according to the company.

“We are pleased with the finding of EFSA’s review of our clinical and safety data supporting Wellmune WGP,” said Richard Mueller, chief executive officer of Biothera. “We have ongoing discussions with a number of companies about product concepts in anticipation of this opinion from EFSA.”

May 13, 2011

FDA Warns on Counterfeit Sex Supplement

WASHINGTON—FDA warned consumers about a counterfeit product represented as the male sexual enhancement supplement ExtenZe, noting the counterfeit product looks similar to the actual product, but contains undisclosed drug ingredients that can cause serious harm to consumers.

FDA conducted a laboratory analysis on the counterfeit product and found it contains undisclosed tadalafil, or a combination of tadalafil and sildenafil, active ingredients in FDA-approved prescription drugs for erectile dysfunction. The agency warned these ingredients may interact with other medicines such as the nitrates found in some prescription medicines such as nitroglycerin, and may lower blood pressure to dangerous levels—men with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates and would be especially susceptible to contraindication with tadalafil or sildenafil.

May 16, 2011

CRN-I Sets Codex Symposium Agenda

MANNO, Switzerland—Codex policy and science will be addressed in two keynote addresses at CRN-I’s second scientific symposium, “Nutrition Issues in Codex: Health Claims and Nutrient Reference Values (NRVs),” on Nov. 12, 2011 in Kronberg im Taunus, Germany. The one-day conference, designed to engage regulators, policymakers, scientists and academics in science-based discussions on nutrition issues related to Codex, will feature keynote addresses by David Jukes and Peter J. Aggett.

Jukes, a senior lecturer in food regulation in the Department of Food and Nutritional Sciences, University of Reading, U.K., will speak about Codex standards and their role in the international regulatory framework. His session will also touch specifically on how Codex documents, including guidelines and standards, can be educational and useful for Codex member governments, providing insights on how these documents are often used as templates for policy and regulatory requirements.