SOURCE: Scilabs Nutraceuticals

Scilabs Nutraceuticals

December 12, 2014 14:02 ET

Scilabs Nutraceuticals Responds to FDA Consent Decree

Manufacturer Has History of Safe, FDA-Compliant Production Free of Consumer Complaints

IRVINE, CA--(Marketwired - Dec 12, 2014) - Scilabs Nutraceuticals Inc.™, a leading contract manufacturer of nutraceuticals based in Irvine, California, today commented on the recent consent decree that it entered into with the United States Food and Drug Administration (FDA), in which the Company agreed to suspend nutraceutical manufacturing operations.

The consent decree came after the company had already temporarily halted manufacturing operations in order to focus on revamping internal procedures. At the time of the consent decree, Scilabs Nutraceuticals was not producing nutraceutical products, thus making the consent decree unnecessary. Despite Scilabs Nutraceuticals' detailed response to FDA's initial warning letter, the FDA failed to provide any response addressing Scilabs' progress.

The FDA's recent injunction against Scilabs Nutraceuticals may stem from allegations the agency has not been sufficiently aggressive in its oversight of the nutritional supplement industry. FDA has brought injunctions against multiple dietary supplement manufacturers in recent years, with 2014 alone seeing numerous more. Nearly every complaint has ended in a consent decree settlement.

Paul Edalat, chief executive officer of Scilabs Nutraceuticals, responded, "While Scilabs Nutraceuticals has an unblemished history of safe, compliant production, we decided to settle with the FDA in order to avoid a lengthy and very costly litigation process. In my 25 years of involvement in nutraceuticals, I have seen the good the FDA has done for our Industry. We would rather work with the FDA than fight them; they play a critical role in consumer safety."

Scilabs Nutraceuticals has a long track record of producing only the safest and highest quality nutritional supplements. This strong and consistent focus on quality and safety has resulted in the company having a record free of either customer or consumer complaints.

Moving forward, Scilabs Nutraceuticals has retained industry expert Dennis Moore and AUK Technical Services to assist with the reconfiguration of internal quality processes. As a former investigator, Moore has over 20 years of experience as an auditor with the FDA and the State of California in the pharmaceutical and medical device industries. Furthermore, Moore's team at AUK consists of industry experts and ex-auditors well versed in FDA compliance and regulations in the nutraceutical and pharmaceutical industries.

"Litigating a consent decree is very costly. Unlike the FDA, Scilabs Nutraceuticals does not have endless financial resources to fight the FDA's allegations. Instead, I look forward to employing my federal and state auditing, investigative, and regulatory affairs experience in assisting Scilabs," said Moore.

About Scilabs Nutraceuticals
Scilabs Nutraceuticals Inc.™ is an FDA and California State Department of Public Health audited and licensed, contract nutraceutical manufacturer based in Irvine, California.

Contact Information

  • For more information contact:
    Tiffany Allegretti
    LFPR for Scilabs Nutraceuticals
    949.502.6200 ext. 218
    tiffanya@lfpr.com