Regulatory News In Brief

FTC probe stalls Vitamin Shoppe deal; NAD gives 5-Hour Energy mixed review; BioNeurix warned for claims; AloeScience Labs’ budget restraints lead to GMP violations; GM Manufacturing fails on sanitation GMPs; more Regulatory News In Brief.

FTC probe stalls Vitamin Shoppe deal

[Vitamin Shoppe Inc.]says a Federal Trade Commission investigation might block its planned acquisition of Super Supplements Inc. The North Bergen, N.J.-based firm said it pushed back the expected completion of the deal from Dec. 31 to March 1 and is cooperating with FTC. In a same-day release, the firm said the $50 million deal might not close in light of the investigation. Food and drug attorneys say that the combined size of the two firms and their product and geographic overlaps could have triggered an investigation into whether the merger would unfairly limit competition in Washington, Oregon and Idaho, where Super Supplements has 31 stores and Vitamin Shoppe has 17. Vitamin Shoppe said it expected the deal would contribute $75 million in revenue in 2013 (Also see "In Brief" - Pink Sheet, 24 Dec, 2012.).

NAD gives 5-Hour Energy mixed review

The National Advertising Division finds Living Essentials, the maker of 5-Hour Energy Supplement, adequately supported the product’s energy performance claims, including “Just one quick drink and you’ll get hours of energy,” and “Drink it in seconds. Feel it in minutes. Lasts for hours.” Included in the evidence the firm submitted was a randomized controlled trial that found 5-Hour Energy provided increased activity for 4.92 hours. However, NAD raised concerns that claims 5-Hour Energy provides energy now with “no crash later – and no jitters” could mislead consumers to believe the product did not contain caffeine. The Council of Better Business Bureaus division recommends the company clearly disclose the presence of caffeine. Likewise, it recommends the firm qualify claims the product provides less of a crash effect than Red Bull and Monster and discontinue the unqualified claims about “no” crash. Living Essentials agreed to modify its advertising to accommodate NAD’s concerns, according to a Jan. 4 release.

FDA warns BioNeurix for claims

FDA says BioNeurix Corp. markets unapproved drugs, including the PharmaTree Blood Sugar 360°,which ispromoted as a nutraceutical for regulating insulin sensitivity and decreasing the risk of glucose-related nerve damage. The Los Angeles-based company targets diabetic consumers on its website www.pharma-tree.com, touting Blood Sugar 360°, with banaba, chromium and ginseng, as a “natural solution” to high blood sugar, FDA’s Oct. 15 warning letter said. The agency also warned BioNeurix about claims that make other nutraceuticals it markets unapproved new drugs, including Amoryn for relief of depression and Mellodyn for chronic insomnia. The Electronic Retailing Self-Regulation Program in 2009 said BioNeurix had sufficient evidence to claim that Amoryn’s main ingredient hyperforin effectively treats mild to moderate depression (Also see "Amoryn supplement claims review" - Pink Sheet, 16 Mar, 2009.).

AloeScience says budget restraints cause GMP violations

FDA notifies AloeScience Labs, Inc. of several good manufacturing practice violations found during an inspection of the Garland, Texas, manufacturing plant between February 27 and March 9, 2012. In a warning letter posted Nov. 14, FDA said the firm did not have product specifications for supplements, failed to have appropriate tests for the identity of four dietary ingredients and did not include documentation in the batch production record of seven lots. The firm responded to the original form 483 that it could not “budget, equip and staff a functional quality control unit,” but FDA said the firm must have quality control personnel and operations for approving and releasing product.

GM Manufacturing fails on sanitation GMPs

Gardena, Calif.-based GM Manufacturing Inc. does not sufficiently clean and sanitize its facility, according to an FDA warning letter detailing dietary supplement good manufacturing practice violations. Although GM told the agency’s Los Angeles district office it performs a monthly “big cleaning” of its manufacturing room, FDA inspectors Jan. 23 to Feb. 13, 2012, found much of GM’s manufacturing room, including its large mixer and tableting machines, covered in powder residue. The company did not provide FDA with a cleaning log or other documentation of any recent “big cleaning,” the letter posted Dec. 25 said. FDA also noted that GM failed to separate adequately the manufacturing of different supplements, allowing employees to encapsulate different products simultaneously in close proximity to each other.

Sterling lacks manufacturing records

Inspectors from FDA’s Los Angeles district office found Sterling USA Neutraceutical Lab LLC’s Glendale, Calif., dietary supplement facility failed to meet several basic good manufacturing practices during a May 2012 visit. Sterling had not prepared master manufacturing records, batch production records or specifications for capsule products, and also performed no dietary ingredient identity testing or supplier qualification activities, the agency’s Nov. 16 warning letter says. The firm’s June 8 response to a form 483 was inadequate and corrective actions will be reviewed upon FDA’s follow-up inspection.