Proponents of increasing Department of Justice enforcement against dietary supplement good manufacturing practices violators and other bad actors could see 2015 as a banner year as a Sept. 25 injunction against a Florida firm exceeds the total for 2014.

Sunset Natural Products Inc. entered a consent decree of permanent injunction that requires it to cease all operations and to receive FDA clearance on GMP compliance before resuming manufacturing and distributing supplements, DoJ announced. The Miami firm agreed in US District Court for the Southern District of Florida to recall and destroy all supplements it manufactured and distributed since April 2014.

The seven federal court decisions so far in 2015 against supplement industry firms, according to DoJ’s website, include prosecution of criminal charges as well as civil complaints. With additional firms likely having failed to correct problems FDA has noted, but continuing their operations, and with three months to go, the tally of federal court decisions on criminal or civil cases in the supplement manufacturing space likely will grow before 2015 ends.

FDA inspected Sunset Natural’s facility in September 2012 and submitted a warning letter on GMP violations in March 2013 before finding the same problems during follow-up inspections in April and September 2014, although the firm responded to the warning “with promises to correct” the problems, according to DoJ’s complaint.

Violations noted in the warning included failing to qualify suppliers; to follow a written master manufacturing record for each formulation of supplement it manufactured; and to establish specifications for any point, step, or stage in manufacturing where control is necessary and written procedures for the responsibilities of the quality control operations. FDA also warned Sunset Natural about drug claims for its products and about misbranding Also see "GMP Warnings Reflect Firms’ Lack Of Commitment – Fabricant" - Pink Sheet, 13 May, 2013..

After decisions on six civil complaints concerning supplement GMP violations were rendered in 2014, DoJ’s uptick in bringing cases in 2015 comes with the industry’s Senate champions, Orrin Hatch, R-Utah, and Martin Heinrich, D-NM, urging Park Doctrine prosecutions against marketers of spiked products Also see "Senators Push Park Doctrine Prosecution For Spiked Supplement ‘Criminal Endeavors’" - Pink Sheet, 20 May, 2015..

The most recent development in DoJ criminal prosecutions concerning the supplement industry was the Sept. 9 sentencing of the owner and president of New Jersey firm Raw Deal Inc. to a 40-month prison term and $1m fine after pleading guilty to conspiring to commit wire fraud, a charge stemming from an FDA investigation that found from at least 2009 through November 2013, he instructed employees to add “fillers,” including maltodextrin, viobin cocoa replacer and rice flours to the dietary ingredients and supplements packaged for the firm’s customers ([A#05150914004]).

In July, DoJ filed a criminal contempt charge alleging the owner of online retailer Risingsun Health continued to sell products with claims of curing diseases despite court orders to stop in 2010 and 2013. DoJ says the Montana firm agreed to cease operations until FDA authorized a return to business but has operated without the agency’s authorization Also see "Industry Roundup: SEC Fines MJN, Criminal Charge For Herbals Seller, Decree Closes Aspen Supplement Marketer" - Pink Sheet, 29 July, 2015..

The first criminal case federal prosecutors reported for 2015, which preceded Hatch and Heinrich’s letter, was an April plea agreement on charges of introducing misbranded drugs into interstate commerce and money laundering for the operator of Floyd Nutrition LLC following an FDA investigation that determined the Pennsylvania firm imported drug-spiked products marketed as weight loss supplements ([A#05150420013]).

Other decisions in 2015 on DoJ civil complaints against supplement firms include a permanent injunction ordered in February against James G. Cole Inc. after the Oregon firm argued First Amendment protection for disease claims made in customer testimonials for its Maxam Nutraceutics. FDA advised DoJ that the firm manufactured supplements under conditions inadequate to ensure their quality and that its products are unapproved and misbranded drugs ([A#05150209005]).

In August, DoJ announced consent decrees for Iowa Select Herbs LLC and for the marketer of Aspen brand and other nutritionals. FDA warned Iowa Select, of Cedar Rapids, in April 2014 that online claims, including papaya leaf “may slow growth of cancerous tumors, according to new research” and “may be the newest cancer-fighting superfood,” rendered its products unapproved new drugs and notified the firm of GMP, misbranding and drug claim problems after an August 2013 inspection of the firm’s facility and its online sales Also see "Industry Roundup: SEC Fines MJN, Criminal Charge For Herbals Seller, Decree Closes Aspen Supplement Marketer" - Pink Sheet, 29 July, 2015..

The owners of Atrium Inc., Aspen Group Inc. and Nutri-Pak of Wisconsin Inc., all of Wautoma, Wis., were warned in 2012 about violations FDA commonly has found since beginning supplement GMP inspections, including failing to conduct appropriate recordkeeping, ingredient testing and labeling practices. The firms agreed to cease operations after failing to respond to multiple chances FDA offered to become compliant while continuing to make and market Aspen brand and other nutritionals ([A#05121126004]).

Other decisions on DoJ prosecutions on criminal charges stemming from FDA investigations include the Sept. 22 sentencing of the former head of Peanut Corporation of America to more than 27 years in prison for convictions on charges linked to salmonella-contaminated ingredients and products that caused widespread illness and multiple deaths from 2007 through 2009 Also see "Enforcement Roundup: Daniel Chapter One, Peanut Corp. Of America" - Pink Sheet, 28 September, 2015..

In March, Johnson & Johnson’s McNeil Consumer Healthcare business agreed to pay a fine of $20m and forfeit $5m in a guilty plea to a misdemeanor charge of distributing adulterated drugs from its Fort Washington, Pa., plant, which recently resumed operations after being closed under a 2011 consent decree J&J entered with FDA ([A#05150907008]).

Sunset Natural Injunction Continues Rise In DoJ Supplement GMP Complaints

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