The company, James G Cole Inc. of Hood River did business as Maxam Neutraceutics. The company has been in FDA’s cross hairs since at least 2010, when it received a warning letter from the agency. That warning letter detailed numerous disease claims, including for conditions such as autism, mood disorders, diabetes and arthritis. Claims cited by the agency included the following: “Maxam constantly fine-tuned AFX to enhance its efficacy, addressing all aspects of Autism Spectrum/ADD/ADHD/RS or any other neural developmental disorders.”
That letter also included a citation against the company for using noncompliant delivery systems. Dietary supplements by statute are supposed to enter the system via the GI tract.
“Your firm markets the above-listed products as dietary supplements. However, your products are labeled as transmucosal sprays for sublingual administration. You also recommend that ‘It is also beneficial to nebulize many of the Maxam products.’ In addition, your firm markets your products AV-Rx, BSAID, and CF-Rx for topical administration. Because these products are not intended for ingestion, they are not dietary supplements,” the agency wrote.
Second warning letter
The company was also the subject of a warning letter in 2012. That letter cited numerous GMP violations including lack of master manufacturing and batch records, failure to conduct identity tests and to establish specifications, lack of a procedure for holding reserve samples and failure to employ adequate quality control staff.
The court held that the company’s products were misbranded drugs because the company had conducted not clincal trials to establish their effectiveness for the disease conditions for which they were marketed, such as autism. The court also held that the products were adulterated because they were manufactured in a non GMP compliant manner. According to FDA, the court found that the state of the defendants’ manufacturing practices was such that the defendants had “no idea what goes into their products.”
The permanent injunction stipulates that the principal, James Cole, and his former general manager Julie D. Graves may not manufacture or distribute their products unless and until they take a number of steps to come into compliance with federal law, including obtaining FDA approval of their drug products or working with an expert to remove all noncompliant claims from their product labels, promotional materials and websites. Such injunctions are usually viewed as a death knell for a company, though certain firms slapped with such actions have stated an intention to try to comply with the conditions and return to business though NutraIngredients-USA is unaware of any that have successfully done so.