121 S. Wilke Road, Suite 301, Arlington Heights, IL 60005

Home and Hospital Visits for Your Convenience

FREE Phone & Video Consultations

Home and Hospital Visits for Your Convenience

Call for a FREE Phone Consultation

847-797-8000

Video Consultations Also Available

The U.S. Food and Drug Administration (FDA) regulates that drugs are on the market and enforces recalls when enough substandard performance, undeclared ingredient, or adverse side effect reports are received. According to the FDA, “recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.” There are three types of FDA recalls—Class I, II, and III. A Class I recall is the most severe, and issued when a product or device is likely to have severe adverse health effects. A Class III recall is issued when a product or device is not expected to have immediate health consequences, but has the potential to be so later. A safety alert is issued “in situations where a medical device may present an unreasonable risk of substantial harm.”

Oftentimes, when the FDA cannot recall a product, the organization will issue a warning that encourages consumers to dispose of it instead. In early March, the FDA issued such a warning about Weekend Warrior, a dietary supplement for men to increase sexual performance. According to Forbes, the drug was recalled “because it is adulterated with thiosildenafil, a chemical analogue of the active ingredient in the erectile dysfunction drug, Viagra.” The drug is sold primarily online, but is also available in select retail stores.

According to Forbes, sexual enhancement drugs have long been a concern of the FDA because of the frequency with which chemical relatives keep “somehow ending up in what are otherwise supposed to be natural supplements.” Forbes notes that natural supplements often “work” because they've actually be tainted with chemical compounds. In the public notification regarding the Weekend Warrior warning, the FDA notes that the notification should additionally “inform the public of the growing trend of dietary supplements or conventional foods with hidden drugs and chemicals.” Drugs that purport the assist with sexual performance are likely suspects.

...

In late December, a previously healthy 28-year-old man from North Carolina experienced liver failure that required a transplant after several weeks of using a dietary supplement called Mass Destruction. According to their website, the “U.S. Food and Drug Administration is advising consumers to immediately stop using” this product, “marketed as a dietary supplement for muscle growth.” The supplement, which contains at least one synthetic anabolic steroid, has been linked to the liver failure of the North Carolina man. “Liver injury is generally known to be a possible outcome of using products that contain anabolic steroids and steroid-like substances,” according to the FDA. The product's ingredients are “undergoing further analysis” by the agency.

The supplement is sold in stores, gyms, and online, but it was not immediately apparent who the manufacturer of Mass Destruction was, according to the FDA. It is manufactured for Blunt Force Nutrition, a distributor based in Sims, North Carolina. According to the FDA, “consumers who suspect they are experiencing problems associated with Mass Destruction or other body building products should consult a health care professional.” Possible symptoms of liver failure and other health risks posed by such supplements can include fatigue, discolored urine, and abdominal or back pain.

All such supplements that contain steroids can pose a danger to consumers, Howard Sklamberg, a director in the FDA's Center for Drug Evaluation and Research, said. It's a good idea to check in with the FDA's product recall page, where consumers can search any recall or advisories about products if they suspect they may be dangerous. Muscle-building supplements, such as Mass Destruction, aren't the only kind of body-altering supplements that have been deemed dangerous: weight-loss pills, herbal supplements, and GNC supplements have also come under fire as of late.

...

Two US Senators recently introduced the Dietary Supplement Labeling Act of 2013. Sen. Richard Blumenthal (D-Conn.) and Sen. Dick Durbin (D-Ill.) say the law is needed to help oversee the ever growing list of dangerous dietary supplements and herbal medications that can cause adverse reactions in people who take these products, but are on the market totally unregulated by the federal Food and Drug Administration (FDA).

The Journal of the American Medical Association reported in its April issue that many supplement manufacturers have purposely added illegal weight-loss chemicals, sexual-enhancement and bodybuilding compounds or other additives, such as excessive caffeine, in their products. These companies are not required to disclose and don't disclose these ingredients on product labels, leaving many consumers unaware of what they are actually ingesting.

“Consumers don't know some dietary supplements are unsafe until they're in the hospital, and by that time it's too late,” says Sen. Blumenthal. He says the bill would require these companies to provide more information about contents on product labels and would also give more authority to FDA by requiring manufacturers to register their products and the ingredients. Manufacturers would also have to provide proof of health-benefit claims.

...
  • Top 100
  • Illinois State Bar Association
  • Illinois Trial Lawyers Asscociation
  • NACBA
  • Manta Member
  • BBB
  • North western suburban bar association
  • 10 Best Personal Injury Law Firms
  • Elite Lawyer
  • Expertise
Back to Top