False promises rebuked by FDA, no tea or vitamin can cure cancer

Bogus cancer “treatments” being marketing and sold without FDA approval were the target of 14 warning letters and four online advisory letters, according to a press release and consumer update from the agency. The 65-plus products listed by the agency include pills, tablets, creams, syrups, sprays, oils, salves, teas, and medical devices, claiming to cure cancer in humans and pets, and have been found illegally for sale online, in retail stores, at flea markets and swap meets, and even at trade shows.

The FDA called these illegal products a “cruel deception,” and urged consumers to stay away from products that have not passed the agency’s review process, designed to ensure the safety and effectiveness of treatments. It listed the following phases or concepts as warning signs that the advertised product was unlikely to be approved by the agency:

  • treats all forms of cancer;
  • miraculously kills cancer cells and tumors;
  • shrinks malignant tumors;
  • selectively kills cancer cells;
  • more effective than chemotherapy;
  • attacks cancer cells, leaving healthy cells intact; or
  • cures cancer.

Additionally, many of the products that were the subject of the warnings were advertised as “natural” or “non-toxic.”

The warning and advisory letters ask the recipient companies to provide written responses to the violations covered in the letters; if the companies fail to respond and make adequate corrections, they could be subject to further actions including criminal prosecution. According to the FDA, the best scenario for consumers who have purchased or used these products is ineffectiveness. It is possible, however, that these products could interfere with proven, beneficial treatments, or even cause direct harm.

FDA opens toolbox for imported food oversight

The FDA is relying on “a range of tools” to ensure the safety of imported foods, in keeping with directives under the FDA Food Safety Modernization Act (FSMA). Because 15 percent of the Food supply is imported, the FDA has developed “a multi-faceted toolkit” to help ensure the safety of imported food. To meet food safety oversight demands, the FDA is allocating resources based upon risk, leveraging the work of other responsible entities in the food supply chain, and combining FSMA tools with existing methods (inspections, physical examinations, sampling/testing).

Food supply

According to the FDA, about 15 percent of the U.S. food supply is imported. However, some aspects of the food supply are predominantly supplied through imports. For example, nearly 50 percent of fresh fruit, 20 percent of fresh vegetables, and 80 percent of seafood are derived from imports. Food supply imports come from more than 200 countries and around 125,000 firms.

Oversight

Dr. Donald Prater, Acting Assistant Commissioner for Food Safety Integration in the Office of Foods and Veterinary Medicine (FVM), noted that under changing oversight protocols, while the level of oversight will be comparable across the food supply chain, “the deployment of the tools may be different.” For example, he noted the requirement that importers verify their suppliers produce food consistent with U.S. food safety standards. He indicated that the goal of imported food safety oversight was not to establish the same system of oversight for domestic and imported foods, but, instead, “to ensure that foods imported from abroad are as safe as those produced domestically.”

23andme approved to market 10 genetic risk tests, FDA simplifies pathway for more

For the first time, the FDA gave DNA-testing company 23andMe authorization to market direct-to-consumer (DTC) genetic health risk (GHR) tests that provide information on an individual’s genetic predisposition to certain medical diseases or conditions. However, in announcing the approval, the FDA cautioned consumers to remember that GHR tests cannot predict the likelihood of developing a disease or condition, which depends on many factors beyond genetics.

23andMe’s GHR tests work by testing a saliva sample, isolating DNA from that sample, and testing it against 50,000 genetic variants. Certain variants are associated with an increased risk for developing certain genetic conditions. The GHR tests approved by the FDA are associated with:

The 23andMe GHR tests were reviewed by the FDA through the de novo premarket review pathway, but in the future, the agency will exempt 23andMe from premarket review for additional related GHR tests, while other companies will also have the opportunity for an exemption after their first GHR tests receive premarket approval. However, this exemption does not apply to GHR tests that function as diagnostic tests, which are often used as the sole basis for major treatment decisions.

In 2013, the FDA issued a warning letter to 23andMe requiring the company to immediately halt marketing for their DNA testing kits until it secured FDA premarket approval. At that time, the FDA noted that 23andMe failed to complete studies that could validate the effectiveness of the DNA test kits and failed to provide additional information requested by the agency (see Citing Risks of Illness, Injury, or Death, FDA Orders 23andMe, Inc. to Stop Marketing DNA Test Kits, December 5, 2013). For this new approval, 23andMe submitted supporting data from peer-reviewed, scientific literature that demonstrated a link between specific genetic variants and each of the 10 health conditions. The FDA also reviewed studies, which demonstrated that 23andMe GHR tests correctly and consistently identified variants associated with the 10 indicated conditions or diseases from a saliva sample.

Risks associated with use of the 23andMe GHR tests include false findings, both false positives indicating incorrectly that an individual has a certain genetic variant, and false negatives indicating incorrectly that he or she does not have a certain genetic variant.

Owner of compounding company at the center of the 2012 meningitis outbreak acquitted of murder

A Boston jury convicted Barry Cadden, the owner and head pharmacist of the New England Compounding Center (NECC), of racketeering and mail fraud in connection with the 2012 nationwide fungal meningitis outbreak but acquitted him of 25 second-degree murder charges. His sentencing is scheduled for June 21, 2017; he faces a statutory maximum sentence of up to 20 years’ imprisonment on each of the mail fraud and racketeering counts.

Outbreak. In September 2012, the Centers for Disease Control and Prevention (CDC) began investigating a multistate outbreak of fungal meningitis and other infections among patients who received contaminated preservative-free methylprednisolone acetate (MPA) steroid injections from NECC. The CDC reported that 753 patients in 20 states were diagnosed with a fungal infection after receiving injections of NECC’s MPA. Of those 753 patients, the CDC reported that 64 patients in nine states died.

Indictment. In December 2014, the U.S. Attorney’s Office in Massachusetts announced a 131-count federal criminal indictment in connection with the outbreak. Cadden and NECC’s supervisory pharmacist, Glenn A. Chin, were charged with 25 acts of second-degree murder in Florida, Indiana, Maryland, Michigan, North Carolina, Tennessee and Virginia. Twelve other individuals associated with NECC, including six other pharmacists, the director of operations, the national sales director, an unlicensed pharmacy technician, two of NECC’s owners, and one other individual were charged with additional crimes.

Prosecutors alleged that Cadden directed and authorized the shipping of contaminated MPA nationwide. In addition, he authorized the shipping of drugs before test results confirmed their sterility, failed to notify customers of nonsterile results, and compounded drugs with expired ingredients. NECC also used fictional and celebrity names on fake prescriptions to dispense drugs.