The FDA just published more warning letters, as it does every Wednesday. These letters are issued to warn a firm or individual that the government considers one or more of their products, practices, processes, or other activities to be in violation of the Food Drug and Cosmetic Act. The letters are issued for violations that may lead to enforcement action.
The FDA looks closely at safety issues and claims made by products that may be unsubstantiated. Anecdotes and testimonials by customers are not scientific evidence that the product maker can use as proof their product performs as claimed. Labels must be accurate and correct, and facilities must be clean, follow good practices, and be free from pests and contamination.
Ming’s Food. This food warehouse and processing plant had serious violations of the Current Good Manufacturing Practice regulations. Unsanitary conditions were found, and product labels were incorrect. Fish, including large mouth bass, catfish, white eel, tilapia, and others, were adulterated since pests were not excluded from the processing areas.
Rodent pellets and hairs were found in the facility, and rodent urine stains were observed. In addition, bathroom doors open directly into processing areas, subjecting the food to airborne contamination.
Revolt Distribution, Inc. This firm had adulterated products called “Wownie Relaxation Cookie” and “Slowtivate Relaxation Drink” that contained melatonin, a neurohormone that is an unapproved food additive. The products are represented as “conventional foods”, but they are actually dietary supplements.
Royal Domains. This company’s product “Nature’s Pearl Premium Muscadine Grape Seed” dietary supplement is marketed for conditions that make it an unapproved new drug, intended for use in the “cure, mitigation, treatment, or prevention of disease.” Some of the unfounded claims on the product and the company’s website include:
- Laboratory tests done by Wake Forest University show Nature’s Pearl inhibiting the growth of 7 different cancers!
- Resveratrol … has been reported to have anti-inflammatory as well as anticancer properties … may counter type 2 diabetes and insulin resistance…
- [muscadine grapes have] been called the new way to prevent cancer …
- “My son asked me to try this product for my arthritis … in seven days the arthritis in my hands was gone.”
Globe All Wellness. These products, SlimXtreme™ Herbal Slimming Capsule and ViaXtreme™ Ultimate Sexual Enhancer Dietary Supplement for men are unapproved new drugs, since they contain drugs that are not declared on the label.
SlimExtreme™ contains sibutramine (Meridia), making it an unapproved new drug. Meridia can cause heart attack, stroke, increased blood pressure, and coma in people with certain medical conditions. More testimonials claim that the product assists with extreme weight loss.
And ViaXtreme™ contains sildenafil, the active ingredient in Viagra, a prescription-only drug used to treat erectile dysfunction.
Blossom Enterprises LLC dba Sea Blossom Seafoods. This seafood processing facility had serious violations of the seafood Hazard Analysis and Critical Control Point (HACCP) regulations. Unsanitary conditions were found, including not heating products to high enough temperatures to destroy Listeria monocytogenes.
Dobake Bakeries, Inc. This bakery had problems with labeling. The products “Raw Almond Croissants” and “Banana Walnut Loaf Cake” did not contain almond or banana, but artificial and natural flavors. And the “Butter Vanilla Loaf Cake” did not contain butter.
Inspectors also observed live insects and rodent pellets within the facility during inspection, included cockroaches crawling on a sink pipe five feet away from bread lines. Rodent pellets were also found in the raw ingredient receiving warehouse.
Butternut Brook Farm. This dairy operation offered for sale animals for slaughter as food that were adulterated. The veal calves had drug residue in their kidneys. Neomycin was found in excess of the upper limit allowed by law.
The farm also held “animals under conditions that are so inadequate that medicated animals bearing potentially harmful drug residues are likely to enter the food supply.”
Breathable Foods, Inc. This company’s product AeroShot is misbranded with false or misleading labeling. The label states the product is “inhalable caffeine”, but it is also suggested that the product can be eaten. Products can’t be intended for both inhalation and ingestion. A product intended for inhalation is not a dietary supplement. Please see our bulletin about this product for more information.
