Policy/Enforcement News

U.S. Customs and Border Protection (CBP) and the Food and Drug Administration (FDA) has seen an increase in tainted products marketed as “all natural” or “100% herbal” that contain undeclared pharmaceutical ingredients that could potentially sicken consumers and counterfeit prescription medications that contain inappropriate ingredients or incorrect dosages.

In a news release, the CBP and FDA said that “counterfeiters have become more sophisticated in deceiving consumers. It can be difficult, if not impossible, to tell the real product from an imposter without sophisticated equipment. Counterfeit drugs may look exactly like real FDA-approved medicines, but their quality and safety are unknown. For example, counterfeit products could contain the wrong ingredients and/or varying amounts of the supposed active ingredient.”

Testifying before the Croydon Crown Court in south London, Peter Gillespie, 64, admitted to aiding in the defrauding of pharmaceutical wholesalers, pharmacists and patients by selling counterfeit cancer drugs, heart disease medication and schizophrenia medication. However, Gillespie denies knowing the false origin of the medication supplied by a business associate he had known for 15…

A federal grand jury has indicted five more people for conspiring to commit extortion under the pretense of being U.S. Food & Drug Administration agents. The false FDA agents allegedly threatened Americans, who had purchased drugs from offshore online pharmacies, with incarceration to extort up to $100,000.

The USFDA announced on February 7th that Jose Miguel Mercado Garcia, 29, of the Dominican Republic, Zulai Morales, 25, of the Dominican Republic, Ramona Pichardo, 51, of New York, New York, Maria Curet, 33, of Providence, Rhode Island, and Milton Goris, 32, of Miami, Florida were indicted. Ramon Pichard was arrested on February 10th, while the remaining defendants are at large.

According to the one count indictment, beginning on December 1, 2007, people claiming to represent pharmaceutical distributors located in the Dominican Republic called and emailed US residents offering to sell pharmaceutical drugs. Purchasers of those pharmaceutical drugs from the Dominican Republic distributors were then instructed to pay via either a money wire service or by credit card.

The indictment alleges that after paying, customers would then receive telephone calls from purported United States FDA agents, who in fact were not FDA agents. The false FDA agents allegedly falsely stated that the customers’ orders from the Dominican Republic had been interdicted, and that the customers now owed fines.

A Providence, Rhode Island resident pleaded guilty on February 8th, 2011, of smuggling erectile dysfunction drugs from the People’s Republic of China falsely labeled as herbal dietary supplements. Anny L. Puello, 32, the owner of JMM LLC, admitted importing thousands of ED drugs that were shipped from a Chinese supplier, Chengdu Kang Quan Health Product Company…

U.S. Pharmacopeial Convention (USP) is providing five sub-Saharan African countries with technical aid to improve the public access to high quality, affordable medicines, announced the organization on February 8th, 2011. USP has launched a pilot Technical Assistance Program (TAP) to provide developing countries with capacity building in medicine quality evaluation. Participating countries will be provided…