New Jersey businesses operating under a 2011 settlement to cease making unsubstantiated weight loss ingredients since then have diverted pseudoephedrine for making methamphetamine, while a Florida business stops selling a product it claimed could treat herpes four years after receiving an FDA warning.

The Department of Justice on March 1 announced that David Romeo, who operated supplement ingredient suppliers Global Nutrients LLC, Stella Labs LLC and Nutraceuticals International LLC, pleaded guilty in US District Court for the District of New Jersey to charges of conspiracy to distribute 3kg or more of "meth precursors," money laundering, mail fraud and introduction of misbranded food into interstate commerce with intent to defraud or mislead.

Starting as early as 2003, Romeo, of Washington Township, N.J., directed employees to use cheaper substitutes in place of the dietary ingredients customers ordered for use in the manufacture of dietary supplements. Romeo's businesses purported to sell the weight loss ingredient hoodia sourced from a rare South African plant, hoodia gordonii, but provided a substance manufactured at a facility in China, causing losses of more than $7m.

Additionally, Romeo's businesses imported from India substances containing ephedrine and PSE, which can be used to make meth. The businesses distributed the substances to customers in California and Mexico, DoJ said.

Sentencing is scheduled for May 18. According to DoJ, the mail fraud charge carries a statutory maximum sentence of 20 years in prison and a maximum $250,000 fine, or twice the gain or loss caused by the offense; the misbranding charge carries a statutory maximum sentence of three years in prison; and convictions on the meth-related charge have a maximum sentence of 20 years in prison.

Special agents of FDA’s Office of Criminal Investigations investigated the false supplement allegations. The Drug Enforcement Agency and the US Postal Inspection Service also worked with DoJ and the US Attorney for the District of New Jersey in the investigation.

FDA, DEA and the USPIC also worked with Justice on investigations of supplement product manufacturers and marketers that led to more than 100 civil complaints and criminal charges DoJ announced in November ([A#05151123005]).

In 2011, Romeo agreed to forfeit a vacation home in Vermont and assign to the Federal Trade Commission the right to collect business loans owed to him as part of a settlement for making false weight loss claims about hoodia. Other executives associated with the false advertising did not face seizures but also were banned from making false claims Also see "In Brief" - Pink Sheet, 7 November, 2011..

Before its settlement with Romeo, FTC said it was prioritizing for investigating weight loss claims made for products containing hoodia, but soon after it began working with FDA to target products containing human chorionic gonadotropin and making unsubstantiated weight loss claims Also see "Agencies Target “Fraud-Driven” HCG Weight-Loss Ingredient" - Pink Sheet, 12 December, 2011..

Complaint Follows Warning On STD Claims

An Ocala, Fla., business entered a consent decree of permanent injunction to stop selling a product it claimed could treat herpes four years after federal officials warned that executives with firms making STD claims for supplements could be prosecuted.

FDA on Feb. 26 said was entered in the US District Court for the Middle District of Florida with James Hill and his business, [Viruxo LLC]. The Department of Justice filed a complaint alleging Hill unlawfully distributed an unapproved new drug and misbranded drug and that he intended to defraud consumers by promoting his product to cure, mitigate, treat or prevent a disease despite the absence of well-controlled clinical studies or any other credible scientific evidence to substantiate his claims.

Under the decree approved by Senior US District Judge James Moody, if Hill intends to resume distributing supplements or drugs, he must notify the FDA in writing at least 90 days in advance and comply with additional requirements:

hire a labeling expert;
remove all representations from his website and other promotional materials that his product can cure, mitigate, treat, or prevent disease;
notify FDA at least 14 days before creating a new website, or link or reference to another website, which conveys information about his products;
receive written permission from the FDA to resume operations.

Hill and his company were among the targets of civil complaints or criminal charges that DoJ announced in November following investigations over 12 months of supplement product manufacturers and marketers Also see "Tracking Federal Agencies’ Enforcement In Supplement Space" - Pink Sheet, 23 November, 2015..

Hill's trouble with FDA and the Federal Trade Commission began in April 2011 in a warning letter about therapeutic claims on his website, which established his product as a drug and as being misbranded because its labeling failed to provide adequate directions for use. However, despite assurances that he was correcting violations noted in the warning, Hill continued to market his product on the internet to consumers as a treatment for herpes, FDA says.

Agency officials at that time also submitted warning letters to 11 other firms making unapproved sexually transmitted disease treatment claims for nutritional products and for homeopathic OTCs and said it would consider prosecuting executives of those firms Also see "FDA Expects STD Claims Enforcement To Deter Future Violations" - Pink Sheet, 9 May, 2011..

An element of FDA's concern is that consumer health care products making unapproved STD treatment claims may pose a significant public health threat because consumers could delay seeking treatment from health care professionals.

Criminal Charges Against Hoodia Suppliers, Consent Decree For Herpes Claim Firm

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