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In an ongoing effort to protect consumers from fraudulent cancer treatments, the FDA sent warning letters to 25 web-based businesses from April 17 to June 9. The warned companies or entities and a list of their 125 "fake cancer 'cure' products" were posted yesterday at the FDA web site. These letters follow a series of warning letters sent by the FTC earlier this year to 112 web sites, which falsely promoted cancer treatments, says the FDA. Consumer complaints and a web search performed by the FDA, FTC, and members of the Mexico-US-Canada Health Fraud Working Group prompted the overdue crackdown.
At least 3 of the targeted entities are already known to the FDA. A search of warning letters at Casewatch indicates that Vitasalus Inc (Nu-Gen Nutrition), Vitapurity, and H&L Worldwide all received earlier letters from the FDA, which claimed that the businesses promoted products for the "cure, mitigation, treatment, or prevention of diseases" in violation of the Federal Food, Drug, and Cosmetic Act. These repeat warnings do not necessarily include the numerous instances in which companies have fraudulently hawked the same products—for example, "Coral Calcium" or "Curcumin"—in rotating fashion as disease treatments.
An FDA warning letter sent to Vitasalus (Nu-Gen Nutrition) in May 2002 cited a single website, cancerchoices.com, and the product Squalamax. However, the most recent FDA letter cites 7 websites and 6 other products, in addition to Squalamax. A Wayback search reveals that 6 of the 7 Vitasalus websites named this year existed in 2002. The 2 other companies, H&L Worldwide (Chang Li) and Vitapurity (Otto Roder), have evidently not moved their cyber or land-based addresses since the time of their FDA warning letters in 2004 and 2005, respectively. Given the number of products promoted by each company and those cited by the FDA this year, business does not seem to have suffered for either company in the interim.
The FDA reports today that more than $100,000 worth of nonprescription Chinese "natural supplements" for erectile dysfunction were seized because they contain sildenafil, the active ingredient in Viagra, or a sildenafil analog. The seized products—Shangai Regular, Shangai Ultra, Super Shangai, Naturalë Super Plus, and Lady Shangai—originated in China and were packaged and distributed by a company in Puerto Rico.
Prompted by a consumer complaint, the FDA conducted an inspection of the Puerto Rico distributor in November 2007, at which time the products' active ingredients were discovered; however, the products' labels did not list sildenafil or the sildenafil analog. An FDA press release in December advised consumers not to purchase the drugs, which were embargoed by the Puerto Rico Department of Health before the seizure.
On February 15, The Netherlands Health Care Inspectorate reported its identification of large doses of tadalafil (Cialis), vardenafil (Levitra) and acetildenafil (an analog of sildenafil) in imported Chinese "herbal" impotence pills. Since 2003, the FDA has recalled a number of nonprescription sex-enhancement pills because they contained undeclared tadalafil, vardenafil, sildenafil, or chemical analogs.
On February 15, The Netherlands Health Care Inspectorate reported its identification of large doses of tadalafil (Cialis; Eli Lilly), vardenafil (Levitra; Bayer, GSK, Schering) and acetildenafil, an analog of sildenafil (Viagra; Pfizer), in imported Chinese "herbal" impotence pills. According to an AP report, thousands of the pills were intercepted approximately 2 weeks ago at Amsterdam's Schiphol Airport and sent for analysis by the Dutch authorities.
The confiscated pills were to be sold under the names Herb Vigour, Natural Vigour, and China Vigour* and were found to contain as much as 2.5 times the maximum dose of one of the selective phosphodiesterase inhibitors, which are FDA approved for the treatment of erectile dysfunction (ED) and available only by prescription. Common, reported serious adverse events associated with these medications in the postmarketing setting—such as cardiovascular events and vision or hearing changes—are more likely to occur with the use of higher-than-approved doses.
A web search reveals that identically named products are currently sold through a number of dubious web sites, several of which identify Kunming Dali Industry & Trade Co, Ltd, in the
The Dutch authorities report that they have not yet identified the manufacturer of the intercepted pills. According to a statement made to the AP, the company name printed on the pills' packaging (which was not revealed in the AP report) has not been verified. The Inspectorate did inform relevant authorities worldwide, including the FDA, of the intercepted pills.
Since 2003, the FDA has recalled a number of nonprescription sex-enhancement pills—"Viga for Women," "Nasutra," "Liviro3," "H S Joy of Love," "True Man's Sexual Energy Nutriment Men's Formula," and "Long Weekend" (big eyeroll there)—because they contained undeclared tadalafil, vardenafil, or sildenafil or chemical analogs.
*Herb Vigour (orange capsules) contains 2.5 times the maximum dose of tadalafil; Natural Vigour (red capsules) contains 1.5 times the maximum dose of vardenafil; and China Vigour (orange-and-gray capsules) contains 1.5 times the maximum dose of acetildenafil, an analog of sildenafil.
