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 warns 55 retailers about e-cigarette, e-liquid, and cigar sales to minors

Warning letters for selling newly regulated tobacco products, such as e-cigarettes, e-liquids, and cigars, to minors have been issued by the FDA’s Center for Tobacco Products against 55 tobacco retailers. The announcement of these warning letters comes approximately one month after the August 8, 2016 effective date of the Final rule (81 FR 28973, May 10, 2016) extending the FDA’s authority over all tobacco products, and making it illegal to sell e-cigarettes, cigars, hookah tobacco, and other newly regulated tobacco products to anyone under age 18 in person and online, and requiring retailers to check the photo ID of anyone under age 27 (see FDA clears the air, ‘deems’ e-cigarettes, hookah tobacco, cigars worthy of regulation, Health Law Daily, May 10, 2016).

Before the Final rule, there were no federal regulations prohibiting retailers from selling e-cigarettes, hookah tobacco, or cigars to people under age 18. The Final rule contains the following restrictions:

  • not allowing products to be sold to persons under the age of 18 years (both in person and online);
  • requiring age verification by photo ID;
  • not allowing the selling of covered tobacco products in vending machines (unless in an adult-only facility); and
  • not allowing the distribution of free samples.

The warning letters were issued after compliance checks of major retail chains, tobacco specialty stores and online retailers found that minors were able to purchase some of the newly regulated tobacco products in a variety of youth-appealing flavors, including bubble gum, cotton candy, and gummy bear. The results from compliance check inspections of tobacco retailers are available in a searchable retailer inspection database. The database lists which inspected retailers received a warning letter, a civil money penalty, a NTSO, or were found to have no observable violations.

The FDA usually issues warning letters to brick-and-mortar retailers as well as online retailers and manufacturers the first time a tobacco compliance check inspection reveals a violation of the federal tobacco laws. Failure to promptly and adequately correct all violations and ensure compliance with all applicable laws and regulations may lead to FDA enforcement actions, including civil money penalties and no-tobacco-sale orders (NTSOs).

Under applicable compliance and enforcement rules, the FDA may pursue a NTSO against retailers that have a total of five or more repeated violations of certain restrictions within 36 months. Retailers are prohibited from selling regulated tobacco products at the specified location during the period of the NTSO. Retailers who receive an NTSO complaint from the FDA may either enter into a settlement agreement with the agency that results in a final order issued by the administrative law judge (ALJ) or choose to go to a full hearing before an ALJ.