In Brief: laxatives warning, FTC settlement, ChromaDex inks 5LINX deal
This article was originally published in The Tan Sheet
Executive Summary
Sodium phosphate laxatives linked to SAERs; FTC scrutinizes personalized supplement claims; NAD refers Xlear LLC to FTC; ChromaDex inks marketing deal with 5LINX; CVS launches vitamin sales, info hub on its website; Star Scientific shareholder suit proceeds.
Sodium phosphate laxatives linked to serious AERs
Adults over 55 and children with certain health conditions should ask a health care provider before using laxatives with sodium phosphates because of increased risk of harmful side effects, FDA warned consumers Jan. 8. Adults and children should ask providers before use if they have kidney disease, heart problems or dehydration, and consumers with colon inflammation or who are taking certain drugs, including ibuprofen and nonsteroidal anti-inflammatory drugs, should not use the products, the agency says. The warnings are not currently on the Drug Facts label and requiring a label change would entail amending the tentative final monograph for OTC laxatives, a process that could take years, FDA says.
A review of the FDA Adverse Event Reporting System from 1969 to 2012 and medical literature from 1957 to 2013 revealed 54 serious adverse events, including 13 deaths. In most cases, the SAEs occurred following overdose. When used correctly by otherwise healthy consumers the drugs, sold under the Fleet brand and private-label, are safe, FDA says. In 2008, FDA amended the OTC oral sodium phosphate label because of a risk of serious kidney injury (Also see "FDA Amends OTC Oral Sodium Phosphate Labeling, Warns Of Risks" - Pink Sheet, 15 Dec, 2008.).
FTC settles over personalized supplement claims
GeneLink Inc. and its former subsidiary foru International Corp. settled charges of deceptive advertising claims that their personalized nutritional supplements “treat diabetes, heart disease, insomnia and other ailments,” and “could compensate for an individual’s genetic disadvantages,” the Federal Trade Commission said Jan. 7. The proposed settlements also resolves charges of lax information security practices. The companies market products personalized based on DNA obtained from a cheek swab. The settlements would prohibit the “the marketers from claiming that any drug, food or cosmetic will treat, prevent, mitigate or reduce risk of any disease … by modulating the effect of a gene, or based on a consumer’s customized genetic assessment – unless the claim is true and supported by at least two adequate and well-controlled studies.”
NAD refers Xlear LLC to FTC
The National Advertising Division referred a review of Spry Dental Defense System to the Federal Trade Commission after Xlear LLC failed to say whether it would appeal or comply with recommendation to modify and discontinue certain advertising claims, according to a Dec. 20 release. After reviewing evidence Xlear submitted for claims about xylitol, NAD recommended the firm discontinue claims that the sweetener from plant fibers is scientifically proven to protect teeth and disclose that xylitol gum should be used with fluoridated toothpaste, is only recommended for healthy children aged 5 to 16 years old and healthy adults at risk of caries. The firm also should disclose that only children who consumed 5 to 8 grams of xylitol daily reaped anti-cavity benefits. NAD said evidence does not support the health results from consuming xylitol are “dramatic,” as claimed by the firm.
ChromaDex inks marketing deal with 5LINX
Multi-level marketer 5LINX acquired the exclusive marketing rights in the U.S., Canada and the Philippines for ChromaDex Corp.’s Niagen nicotinamide riboside for use in dietary supplements sold in the network marketing sales channel. Under the terms of the deal announced Jan. 6, 5LINX must purchase from ChromaDex $2.1 million worth of Niagen in 2014 and an aggregate of $46 million of the product from 2015 through 2017. 5LINX also must purchase $520,000 of PureEnergy caffeine alternative in 2014 and a total of $14 million of the product from 2015 through 2017. “We believe the network marketing channel is ideal for the early development and adoption of Niagen- and PureEnergy-based” products, ChromaDex Founder and CEO Frank Jaksch said in a statement.
CVS launches vitamin sales, info hub on its website
CVS/pharmacy launched a new vitamin sales and information hub within its CVS.com website on Jan. 6. The “Family Vitamin Center” is designed to help customers learn about supplements that can support their health goals, personalize product recommendations through an interactive questionnaire and guidance tools, and allow users to shop for supplements based on 16 health and wellness goals, such as heart health, immune support and probiotics. Visitors to the site also can sign up for “Ship & Save,” a mail-order service that automatically replenishes vitamins and supplements at a discounted price and with free shipping.
Star Scientific shareholder suit proceeds
A shareholder lawsuit alleging Star Scientific Inc. management misled investors about a federal investigation into its Antabloc dietary supplement can proceed, according to a ruling in U.S. District Court for the Eastern Virginia. The complaint argues that Star waited until March 2013 to inform investors of an investigation that began in January 2012 into its securities transactions, and that Star made misleading statements about tests and benefits of the active ingredient in Antabloc – anatabine, an alkaloid from plants in the Sloinacea family. A hearing is scheduled for March 12 to consider class-action status for the complaint, and a jury trial is scheduled to start Sept. 15, court records state. FDA also warned Star in a letter that supplements containing anatabine are unapproved drugs because Star received approval from the agency to study anatabine as an investigational new drug (Also see "Star Scientific IND Blocks Supplement Marketing Options – FDA" - Pink Sheet, 6 Jan, 2014.).