Enforcement In Brief

Exec charged in bird flu claim case

California businessman Charles Hensley pleads not guilty to federal charges of illegally importing and distributing a dietary supplement promoted as a treatment for avian flu. The U.S. Attorney’s Office for the Central District of California said June 2 Hensley was arrested in Redondo on misdemeanor charges including introducing an unapproved new drug to interstate commerce and felony charges of illegally importing an unapproved drug into the U.S. According to the Los Angeles-based federal prosecutor, Hensley in 2005 sought to sell a product branded as Vira 38 as a supplement through PRB Pharmaceuticals. FDA warned PRB in 2005 that it could face "far more serious enforcement activity" if it did not discontinue claims that Vira 38 could protect against bird flu (Also see "“Fowl” Play? FDA Warning Letters Target Avian Flu Supplement Marketers" - Pink Sheet, 12 Dec, 2005.).

Hensley was identified as a co-creator of Zicam cold remedy. The prosecutor’s office noted the case "has nothing to do with Zicam." Hensley sold his stake in Zicam to Matrixx Initiatives in 2001.

Jury finds supplement firms in contempt

A Trenton, N.J., jury June 2 convicts two supplement firms, their owner and managers of criminal contempt for opening and re-opening manufacturing facilities without first addressing rodent and cross-contamination problems as mandated in a consent decree with FDA. Quality Formulation Laboratories and American Sports Nutrition, their owner and managers "almost immediately" violated a consent decree requirement that they shut down and not reopen anywhere their manufacturing operation without fixing good manufacturing compliance practices violations and obtaining FDA approval, according to the Department of Justice.

While they continued to receive and manufacture product at a facility that FDA inspectors deemed unsanitary, executives at the firms also moved employees and equipment to a plant in Conger, N.Y., without notifying FDA, the jury found. Sentencing is in the case scheduled for Sept. 7.

Cellular Rx makes unapproved drug claims

Cellular Rx must discontinue claims on its website and Facebook page that Cell Pro 7 relieves arthritis, migraines, asthma and cardiovascular issues among other claims that make the compound an unapproved drug, FDA warns the Wichita, Kan., firm in a May 25 letter. The agency also warns that consumer testimonials on the firm's website cause the product to be misbranded because they tout it as treatment for symptoms that are not suitable to self-diagnosis. Firms are responsible for the content of testimonials and must be able to support them, the Federal Trade Commission says (Also see "FTC Testimonial Guide Moves Past "Results Not Typical," Enters Blog Era" - Pink Sheet, 12 Oct, 2009.).

Novel delivery makes product unapproved

FDA warns Allure Laboratories that many of its drug products marketed for over-the-counter use are unapproved or misbranded. FDA says in a May 24 letter that the Hayward, Calif., firm's "cosmetically elegant roll-on gel formulated for ingrown hairs" is an unapproved and misbranded drug because it affects the structure or function of the body, is not included in the OTC Drug Review, includes undeclared aspirin and does not comply with drug labeling format requirements.

The firm's Progesterone Crème also is a new drug because it delivers progesterone in a novel topical form and it is not generally recognized as safe and effective, among other reasons. Likewise, several eyelash products are unapproved new drugs because they claim to treat and prevent diseases such as alopecia, FDA says. The agency also points out several significant good manufacturing practice violations uncovered during an inspection Oct. 18 through Nov. 22, 2010.

Device approval won't fly for topical OTC

Just because FDA approved MyClyns Personal Protection Spray as a medical device solution does not mean Union Springs Pharmaceuticals can market the wound cleanser as a topical OTC antimicrobial product, the agency warns the Erlanger, Ky., firm in a May 23 letter. The spray is cleared as a mechanical cleanser, not as an antimicrobial, which is how the firm's website positions the product. The website also inappropriately directs consumers to use MyClyns on mucous membranes even though there is no evidence such use is safe or effective, FDA notes. Nor is there evidence to support claims the product can prevent Methicillin-Resistant Staphylococcus Aureus (MRSA), HIV or Hepatitis C – all of which are prohibited claims for OTC products. Finally, the product lacks a "Drug Facts" panel, FDA says.

"No tolerance" for pesticide residue

Inspectors found residue of the chemical pesticides chlorpyrifos and pentachlorobenzonitrile in a sample of Hsu's Ginseng Enterprises' Root to Health American ginseng supplement, according to a May 13 FDA warning letter. The residue makes the product unsafe because there is "no tolerance" for the pesticide in food, the agency explains. FDA uncovered the contamination during an inspection of the firm's Wausau, Wis., facility Nov. 30 through Dec. 2, 2010, the letter notes. Inspectors also remind the firm that it should support expiration dates on product labels with data. They also found several GMP violations.

ED claims make a supplement a drug

Claims that Duro Extend is a "male enhancer" that "may help increase pleasure and performance" make the product, labeled as a dietary supplement, an unapproved drug, FDA warns Intelli Health Products in an April 27 letter.

Multiple lots of Duro Extend also were found to contain undeclared sulfoaildenafil and/or aildenafil, analogues of the prescription erectile dysfunction drug sildenafil. The Odessa, Fla.-based firm voluntarily recalled all lots of Duro Extend Dec. 2, 2010 (Also see "FDA Recalls -- March 23, 2011" - Pink Sheet, 28 Mar, 2011.).

FDA also warned Ethos Environmental of Irvine, Calif., that its Regenerect is not a supplement but a new, misbranded drug. In a May 25 warning letter, FDA says the product also contains sulfoaildenafil and that claims such as "better than Viagra" qualify as drug claims, not structure/function claims.