FDA inspected the Cheyenne, WY-based firm in December, and issued its warning letter earlier this month. The agency took the opportunity while at the firm to review its claims practices and between labels, and the firm’s various websites, the agency came up with 47 separate citations on disease claims.
The agency inspected the company’s facility in December, 2014, and it conducted a review of the company’s website language in March of this year. Website reviews can happen at any time, and companies should expect their labels to be under scrutiny during an inspection, said Denver-based attorney Jason Sapsin, who is with the firm Faegre Baker Daniels.
“Sometimes in the course of inspection, FDA will ask for labels regardless,” Sapsin told NutraIngredients-USA.
Sapsin said the warning letter stood out for the sheer volume of citations it contained (the warning letter text runs to more than 5,000 words). But it also points out an old refrain in the dietary supplement business: You can’t put up disease claims, even those that might be sincerely believed, on subsidiary websites and expect FDA not to notice. FDA cited disease claims on the company’s product labels and on two websites: countrydoctorherbal.us and countrydoctornutritionalcenter.us.
“It seems hard to believe that FDA is still writing warning letters on this.
Some companies still seem to believe that if they split up their web presence they can reduce their exposure or that what appears on one web site won’t be attributable to others. It’s just not the case,” Sapsin said.
Specific citations
Among the disease claims on the company’s labels that FDA cited were:
“All natural herbal formula that helps balance blood sugar” and “All natural herbal formula that works to rid the body of flu.” But the most over-the-top claims appeared on the company’s subsidiary nutritional center site. There, claims included “Excellent for broken bones, spinal curvature, calcium spurs…and osteoporosis,” “[H]elpful for all the following conditions:…depression…insomnia…” and “Enhances treatment of periodontal disease, diabetes and muscular dystrophy.”
Country Doctor Herbals was also cited for a number of GMP violations that dealt with insufficient quality control procedures and failure to establish product specifications, master manufacturing records and batch production records.
Sapsin said that intent does not play a role in the agency’s evaluation of disease claims.
“The old rule still applies. Whenever you are suggesting, even with the best of intentions, that your product will help someone with their disease, you are in new drug territory,” he said.