DOJ Announces Another GMP Consent Decree for a Dietary Supplement ManufacturerNovember 20, 2014
By Riëtte van Laack –
On Nov. 13, 2014, DOJ announced another Consent Decree of permanent injunction regarding the manufacture and distribution of dietary supplements.
Under the Consent Decree, contract manufacturer SciLabs, Inc. and its CEO Paul Edalat are prohibited from the manufacture and distribution of dietary supplements until FDA has determined that the company is in compliance with the dietary supplement GMPs.
According to the complaint, inspections in 2012, 2013, and 2014 revealed that SciLabs violated the dietary supplement GMP requirements causing the dietary supplements, distributed under the brand All Pro Science, to be adulterated. In January 2013, FDA issued a Warning Letter alleging numerous violations of the GMP requirements observed during the 2012 inspection. FDA claims that SciLabs expressed its intent to comply but the company did not provide documents to support the corrective actions. Moreover, according to DOJ, the company failed subsequent inspections in 2013 and 2014. Based on this record, DOJ concluded that “unless restrained by [the] Court, Defendants [would] continue to violate” the GMP requirements.
The Consent Decree appears to, at least temporarily, put the company out of business. The company must recall and destroy all products manufactured since August 2012 and any inventory. In addition, the company must shut down until it has taken all required corrective actions and FDA confirms, in writing, that the company is in compliance. The Consent Decree specifies that, if the company wants to reopen, it must hire an independent GMP expert to help with compliance issues. The expert must certify to FDA that the company has corrected all deficiencies and is in compliance with GMP requirements. Only once FDA confirms that it agrees with the expert may the company reopen for business. In addition, SciLabs must “have paid all costs of FDA’s inspections, investigations, supervision, analyses, examinations, and reviews.”
Once the company resumes manufacturing, it must retain an independent expert to conduct audit inspections at least every 6 months for a period of five years.
Earlier this year, at least three other dietary supplement manufacturers entered into similar consent decrees (see here, here, and here). Similar to SciLabs, those companies allegedly failed several inspections and, all but one, received a warning letter alleging violation of GMPs but, according to FDA, failed to take the appropriate corrective actions.
These cases show that FDA will aggressively pursue violators of the dietary supplement GMP requirements. Because the consent decrees include a recall provision, a shut-down provision, and a requirement that FDA confirm that they are in compliance before they can reopen, the companies may well end up being put out of business permanently.
FDA does not bring a lot of injunction cases per year. Four (or more) injunctions related to dietary supplement GMP suggests that this area is a high enforcement priority for the Agency.