FDA files injunction against sports supplement manufacturer over years-long record of GMP failures

14-Nov-2014 - Last updated on 14-Nov-2014 at 16:05 GMT

Scilabs Nutraceuticals Inc., a California dietary supplement company, has been slapped with a permanent injunction after failing three rounds of FDA inspections and receiving a warning letter in 2013.

The US Court for the Central District of California issued the injunction Wednesday against the Irvine, CA-based company and its CEO, Paul P. Edelat, to prevent the distribution of adulterated dietary supplements, according to the Justice Department.

SciLabs Nutraceuticals Inc. is a contract manufacturer of dietary supplements distributed under the brand name All Pro Science, including Complete Immune + capsules and various flavored powders called Complete, Recovery and Precharge. The department filed a complaint in the U.S. District Court for the Central District of California at the request of the U.S. Food and Drug Administration (FDA), alleging that the company’s dietary supplements are manufactured under conditions that are inadequate to ensure the quality of its products.

Cessation of operations

In conjunction with the filing of the complaint, the defendants agreed to settle the litigation and be bound by a consent decree of permanent injunction that prohibits them from committing violations of the Federal Food, Drug, and Cosmetic Act. The consent decree requires the dietary supplement manufacturer to cease all operations and requires that, in order for defendants to resume manufacturing dietary supplements, the FDA first must determine that Scilabs’ manufacturing practices have come into compliance with the law.

According the complaint, FDA performed inspections in 2012, 2013 and 2014 all of which found serious GMP violations at the company’s manufacturing plant. For example, the complaint alleges that the company failed to conduct at least one appropriate test or examination to verify the identity of every dietary ingredient before using them. The company also allegedly failed to establish product specifications for the identity, purity, strength and composition of finished batches of dietary supplements. In addition the company failed to keep proper equipement logs documenting the use, maintenance, cleaning and sanitization of individual pieces of equipment.

A permanent injunction is the end of a long road noncompliant companies take with FDA. While it is an arrow in the agency’s quiver, it is one only rarely notched to the bow, though that seems to be changing, according to Marc Ullman, an attorney with the firm Ullman, Shapiro & Ullman.

“You have to push FDA pretty hard to get them to slap an injunction on you. That being said, injunctions seem to be becoming less uncommon over time,” Ullman told NutraIngredients-USA.

2013 warning letter

Along with the unsatisfactory inspections, FDA sent a warning letter to SciLabs in January, 2013. The warning letter listings “serious violations” of the GMP regulations that were discovered in two inspections in 2012 including:

1. Failure to establish required quality control specifications for select points, steps, or stages in the manufacturing process.

2. Failure to test the identity of dietary ingredient components, and to confirm the identity of other components.

3. Failure to prepare and follow a written master manufacturing record for each unique formulation of a dietary supplement

4. Failure to complete a batch production records

5. Failure to establish and follow written procedures for calibration of instruments and controls

FDA also alleged the company misbranded dietary supplements by failing to “include a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event with such dietary supplements”.

To read the full warning letter, please click here.

After receiving that letter, SciLabs was inspected at least two other times. In the court complaint filed on Nov. 5, FDA said “[SciLabs] have previously violated the act. Several of the [violations] observed during the most recent inspection are the same as, or similar to, those observed by FDA during a previous inspection of [SciLabs’] facility on Sept. 17-20, 25, and Oct. 25, 2013.”

Divided attention

During at least a portion of its interaction with FDA Scilabs’ attention seemed to have been directed elsewhere. The company was embroiled in a breach of contract lawsuit with former NFL player Tony Gonzalez (who cofounded the All Pro Science brand with Edelat) and in late 2012 it hired a high profile public relations firm called MSW Communications Group to handle public relations surrounding the litigation.

It’s an open question whether SciLabs can resume operation. In theory it’s possible, assuming the company can revamp its operations and then satisfy FDA that it can operate within the law in the future. But’s it's unlikely, Ullman said, because of the time and money involved and because the effort would require a complete overhaul of the company’s corporate culture.

“It’s rare for companies to be able to resume operations, given what’s involved,” Ullman said. “The injunctions invariably require FDA to sign off before you can start up again.”