Cape Fear Naturals and its owners, Lynda Whitley and James Whitley, have been formally warned by the US Food and Drug Administration, or FDA, after a September 2016 inspection of the family-owned business turned up what the agency is characterizing as “significant violations” of Current Good Manufacturing Practice requirements for “herbal” and “natural” supplements.
Cape Fear Natural’s Contracted Dietary Supplements
The company’s dietary supplements are contracted out but the company still has a legal obligation to make sure that the products are safe and contain the ingredients claimed, says the FDA. But during the inspection, agents found that Cape Fear Naturals had no procedures in place to do that.
The company apparently tried to address the issue after the inspection but the agency rejected the plan, deeming it “inadequate”.
Cape Fear Naturals’ Website Claims
The inspection was not just of the company’s facility in Wilmington; agents also visited the family’s website a few weeks later and found multiple instances of unallowed medical claims attached to several products. A few of those claims, found on labeling and/or the website, included:
- Promises to treat various intestinal issues, including diarrhea, irritable bowel syndrome, Crohn’s disease and microbiota imbalance
- Promises to treat infections including urinary tract infection, respiratory infection and vaginal yeast
- Prevention and treatment of cancer
- Scar reduction
- Treatment of skin conditions like warts, dermatitis and rosacea
Of course, none of Cape Fear Naturals products have been FDA-recognized as safe or effective for any of those conditions. By attaching such claims, says the agency, Cape Fear Naturals has introduced new and unapproved drugs.
Some of CFN’s products are further “misbranded” because they are hawked for conditions that a layperson is not equipped to effectively and accurately self-diagnose or self-treat.
Cape Fear Naturals’ Complaints Procedures
The business owners admit that they have received customer complaints about some of their products in the past but the company apparently does not document those complaints or investigate them. Again, the company addressed this oversight after the inspection but was told its response was “inadequate” because it didn’t meet current regulatory standards.
There were more issues and the agency warned CFN that its letter was not intended to list every single violation the agency is alleging. As is always the case with alleged violations like these, the company was given 15 working days to address the agency’s concerns.
The FDA’s warning letter to Cape Fear Naturals and its owners, Lynda Whitley and James Whitley was dated March 02, 2017.