MyNicNaxs, LLC, Deltona, FL is voluntarily recalling all lots of dietary supplements distributed nationwide to consumers and stores. All lots means every bottle that went out of their warehouse, of every product they were selling.
Unfortunately, they are not the first company who needed to recall weight loss and sexual enhancement products. These niches seem to be rife with undeclared, misleading, and plain dangerous pills. Dozens of weight-loss and immune-system supplements on the market are illegally labeled and lack the recommended type of scientific evidence to back up their purported health claims.
Cautionary Tale
MyNicNaxs, LLC, Deltona, FL, is- or was- a company selling both dietary supplements for weight loss and sexual enhancement. Unfortunately, the dietary supplement (or “chinese medicine”) was a misleading name for products that contained undeclared active pharmaceutical ingredients.
Drugs, in other words.
The FDA went to court to complain. First, they alleged that certain MyNicNaxs products are drugs under the FD&C Act because they are intended to cure, mitigate, treat or prevent disease.
Second, the drugs were misbranded because their labeling was false and misleading in that it didn’t declare certain active pharmaceutical ingredients. The labeling failed to bear adequate directions for use, and/or the drugs are dangerous to health when used as recommended in the labeling.
The following permanent injuction required the defendants to stop distributing any unapproved new drugs or misbranded drugs. They were prohibited from receiving, manufacturing, holding and distributing any drugs or dietary supplements until the FDA puts out a written notification that they are in compliance of the FD&C Act and its regulations, and that they may resume operations.
The MyNicNax website is down, but the pinterest account is still up with photos of the products and promotional photos.
Harmful Substances
The FDA discovered the presence of Sildenafil, Sibutramine, Diclofenac and/or Phenolphthalein in the dietary supplements. This rendered the supplements as an unapproved drug for which safety and efficacy have not been established.
These products were distributed from January 2013, to December 2017, though the website http://www.mynicnaxs.com.
The undeclared drugs can cause serious health risk. A)Some of them are cancerous, and B)Taking drugs unknowingly can interfere and interact with other drugs the person is taking. Or can expose the consumer to a drug that is harmful or dangerous in their particular situation… a drug they would never take if they knew it was in the magic pill.
The following drugs were detected in the products:
Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the U.S. market on December 21, 2010, after clinical data indicated Sibutramine poses an increased risk of heart attack and stroke.
Phenolphthalein is a known carcinogen (cancer causing agent) It was once an ingredient used in over-the-counter laxatives. It is no longer approved for marketing in the United States.
Sildenafil is the active pharmaceutical ingredient in Viagra (PDE-5 inhibitor), a drug approved by FDA for the treatment of erectile dysfunction. PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin). PDE-5 inhibitors can lower blood pressure to dangerous levels.
Diclofenac is a non-steroidal anti-inflammatory drugs (NSAIDs) found in FDA-approved drugs that are used to treat pain and inflammation associated with several conditions. NSAIDs could lead to serious GI trouble, like bleeding, ulceration, and fatal perforation of the stomach and intestines.
Patients who are already taking medication that could cause bleeding may increase their risk for bleeding significantly.
This is a list of all the website products, as listed on the FDA website: 26 products in all that did not disclose drugs in the ingredient list on the bottle.
| Product Description | API Found in FDA Lab Results |
|---|---|
| Platinum Maximum Strength Blue Pill Version; 30 capsules; 500mg each |
Sibutramine and Phenolphthalein |
| Platinum Maximum Strength Blue Pill Version; 30 capsules; 500mg each |
Sibutramine and Phenolphthalein |
| Slimming Plus Advanced Weight Loss; 30 capsules; 500mg each |
Sibutramine and Phenolphthalein |
| African Viagra – sexual performance enhancement product; 4500mg x 2 |
Sildenafil |
| GINSENG – sexual performance enhancement product; 300mg/tablet x 10 tablets |
Sildenafi |
| African Superman – sexual performance enhancement product; 2900mg x 8 tablets per blister pack |
Sildenafil |
| Old Chinese – sexual performance enhancement product; 19800mg x 10 capsules |
Sildenafil |
| Lean Extreme Max; 30 capsules; 400mg each | Sibutramine |
| X-treme Beauty Slim; 30 capsules; 350mg each | Sibutramine |
| African Superman – Top-Class Permanence Tablet; 2900mg x 8 tablets |
Sildenafil |
| Slim Evolution – 100% Natural Ingredients; 30 capsules; 350mg each |
Diclofenac |
| Meizitang Strong Version capsules packed in a non-flexible clear bottle with a green screw-on top |
Sibutramine |
| Magic Slim capsules packed in a non-flexible white bottle with a white screw-on top |
Sibutramine |
| Slim Xtreme capsules packed in a non-flexible white bottle with a white screw-on top |
Sibutramine |
| Meizi Evolution capsules were packed in a non- flexible clear bottle with a blue screw-on top |
Sibutramine |
| SlimEasy Herbs capsules packed in blister packaging and placed in a white box with black labeling |
Sibutramine |
| Hokkaido – capsules packed in blister packaging in pink box with black labeling |
Phenolphthalein |
| Super Fat Burning Bomb capsules in blister packs, packaged in a red box with black labeling |
Sibutramine and Phenolphthalein |
| FRUTA Bio blister packs, packaged in a yellow/green box with green labeling |
Sibutramine and Phenolphthalein |
| JIANFEIJINDAN Activity Girl – blister packs, packaged in a white/pink box with pink labeling |
Sibutramine |
| Reduce Weight FRUTA PLANTA blister packs, packaged in a yellow/green box with green labeling |
Phenolphthalein |
| Fat Loss Slimming Beauty – 30 capsules in blister packs packaged in yellow/black box -500 mg |
Sibutramine and Phenolphthalein |
| Fruta Planta -blister packs packaged in yellow/green box with green labeling |
Sibutramine and Phenolphthalein |
| Botanical Slimming – 100% Natural Soft gel; 30 soft gels; 650mg each packaged in a green bag with yellow and white lettering | |
| Slim Body – Dietary Supplement;100% Herbal Slimming Formula; 30 capsules; 6x5x300mg blister packs, packaged in blue and red box | |
If you have bought any of these products, you are advised to immediately discontinue use.
There have been no reports of adverse effects so far. If you think you have experienced adverse effects, speak to your health care provider immediately. You should also report to the FDA MedWatch Adverse Event Reporting Program by filling out the online form, or sending the form by regular mail or fax.
For any questions regarding this recall, contact Mike Banner by phone 407-791-3597 or Chevonne Torres 386-337-8142, Monday to Friday, 09:00am-5:00 pm, Eastern Time.