Manufacturer of Fruta Planta Weight Loss Supplement Issues Drug Recall for Undeclared Pharmaceuticals

The manufacturer of weight loss supplement Fruta Planta has issued a drug recall for their product due to the inclusion of an undeclared and dangerous pharmaceutical.

MyNicKnaxs, LLC, based in Florida, has issued a drug recall for Reduce Weight Fruta Planta because it contains a little more than 10 mg of Phenolphthalein. The manufacturer says that the drug recall is voluntary, and there have been no illnesses, injuries, or deaths associated with ingesting the weight loss supplement.

Phenolphthalein was once an active ingredient in over-the-counter laxatives. However, after concerns regarding its potential to cause cancer arose, the drug’s FDA approval was revoked and it is no longer legal for use in the United States.

Because any amount of phenolphthalein was used in the manufacture of Fruta Planta, the supplement is now considered an unapproved new drug with no established safety or efficacy testing. Long-term consumption of this product can cause symptoms like irregular heart-beat, gastrointestinal problems or disturbances, and cancer.

Consumers should immediately discontinue use of all Fruta Planta weight loss supplements. Any consumer questions can be directed to MyNicKnaxs, LLC at 386-337-8142 or via e-mail at [email protected] Monday – Friday, 2pm – 7:00 pm, EDT.

Any consumer who has had an adverse reaction to this supplement should contact the FDA’s MedWatch Adverse Event Reporting program:

• Online: www.fda.gov/medwatch/report.htm link
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm. link Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

Unapproved Ingredients in Dietary and Weight Loss Supplements Make Up Half of Dangerous Drug Recalls in the US

US researchers have found that dietary supplements, which often contain unapproved or unlisted ingredients, make up just over half of all dangerous drug recalls in the United States.

Analysis of FDA data from a 9-year period showed that 51% of Class I recalls – the most serious recalls issued by the FDA – involved adulterated dietary supplements, and not pharmaceutical products. The study was conducted by Ziv Harel, MD, of St. Michael’s Hospital in Toronto, and colleagues, in the Journal of the American Medical Association (JAMA).

Most of the dangerous drug recalls were issued for supplements that claimed to boost sexual performance, build muscle, or aid weight loss. “Supplements” are allowed to contain vitamins, minerals, and herbs, but they are not allowed to contain pharmaceuticals.

The study called for much more stringent guidelines to regulate dietary supplements. Currently, the market has very little FDA oversight. Federal law does not require that supplements – which are supposedly herbal rather than pharmaceutical – go through the FDA for approval before they can be packaged and sold.

However, because of the lack of oversight, supplements containing pharmaceutical compounds have entered the market. About 24% of the recalled supplements were manufactured outside the US. The study noted this is a concern, as other countries do not adhere to the same manufacturing practices.

The Strom Law Firm Can Help with Dangerous Drug Recall Cases

Strom Law Firm, L.L.C. is a leader in the consumer protection battle against dangerous drug recalls and defective devices. We represent individuals who have been killed or injured by dangerous or defective pharmaceuticals. If you or a family member have been injured or killed after using a dangerous drugs or weight loss supplements, contact our dangerous drug lawyers as soon as possible so that we can begin taking steps to preserve evidence and your claim immediately. We offer free consultations to discuss the facts of your case. 803.252.4800