11.13.14
The Council for Responsible Nutrition (CRN) has developed a free online tool that compiles FDA Warning Letters sent to dietary supplement companies into a searchable database to help industry achieve better regulatory compliance. The database can be used to evaluate FDA’s warning letter allegations of good manufacturing practices (GMPs) violations, products making impermissible claims, and products tainted with illegal ingredients.
According to CRN president & CEO Steve Mister, “Our goal is to help companies in the supplement industry better understand the types of transgressions that will trigger a Warning Letter from FDA, so that all companies can learn from others’ mistakes and identify priorities in FDA enforcement, thereby raising the level of compliance with the law.”
The database is searchable by key criteria including: product name; company; ingredient; issue date; potential violations; regulations cited; FDA district office issuing the warning; or a combination of criteria. It includes almost 300 Warning Letters publicly released by FDA from January 2008 through August 2014, to companies that the agency claims: 1) have violated dietary supplement GMPs1; 2) are illegally marketing a dietary supplement that contains undisclosed pharmaceutical ingredients; or 3) are making impermissible claims to prevent, treat, cure or mitigate a disease.
“Monitoring violations cited in FDA Warning Letters is one of the best ways to understand the agency’s current enforcement priorities and expectations,” Mr. Mister noted. “When companies have compliance questions, they can search previous Warning Letters for similar circumstances and review the contents of those letters to consider the positions taken by the agency in those situations, and avoid these mistakes.”
The database also has value for consumers. “While all Warning Letters are serious in their indication that a regulation has been violated, not all warning letters are considered equal,” said Mr. Mister. “If you look at the three main categories that these letters cover, the most egregious—and the one that consumers should pay special attention to—are the Warning Letters that address products that are marketed as dietary supplements, when in fact, they contain undeclared drug ingredients. I’m especially concerned by the products in this category and we’d urge consumers to avoid those products. We’d further urge FDA to quickly escalate its enforcement action for these products beyond the Warning Letter stage, as these products could be dangerous to consumers."
Mr. Mister further advised that because FDA does not always issue Warning Letters for products it has found to be adulterated—in some cases the agency instead uses other regulatory tools such as consumer advisories or product seizures—CRN recommends that consumers also check out a website created by the American Herbal Products Association, Keep Supplements Clean, which lists public notices of tainted products.
A second category of violations included in the database is letters alleging improper statements made in labeling or websites that claim to prevent, treat, cure or mitigate diseases. Mr. Mister urged consumers to be skeptical about these product claims and to talk with a health care practitioner before relying on these claims that could inappropriately raise expectations as to the product’s benefits.
The third category addresses more technical GMP violations that are discovered during FDA inspections, ranging from minor technical issues to serious gaps in quality. This category would likely be of little use to consumers, but would be of great interest to manufacturers trying to ensure they don’t receive an FDA Warning Letter following an inspection.
CRN’s FDA Warning Letters database is accessible through the association’s website. New Warning Letters are released by FDA every Tuesday, and CRN will update the database on a monthly basis.
According to CRN president & CEO Steve Mister, “Our goal is to help companies in the supplement industry better understand the types of transgressions that will trigger a Warning Letter from FDA, so that all companies can learn from others’ mistakes and identify priorities in FDA enforcement, thereby raising the level of compliance with the law.”
The database is searchable by key criteria including: product name; company; ingredient; issue date; potential violations; regulations cited; FDA district office issuing the warning; or a combination of criteria. It includes almost 300 Warning Letters publicly released by FDA from January 2008 through August 2014, to companies that the agency claims: 1) have violated dietary supplement GMPs1; 2) are illegally marketing a dietary supplement that contains undisclosed pharmaceutical ingredients; or 3) are making impermissible claims to prevent, treat, cure or mitigate a disease.
“Monitoring violations cited in FDA Warning Letters is one of the best ways to understand the agency’s current enforcement priorities and expectations,” Mr. Mister noted. “When companies have compliance questions, they can search previous Warning Letters for similar circumstances and review the contents of those letters to consider the positions taken by the agency in those situations, and avoid these mistakes.”
The database also has value for consumers. “While all Warning Letters are serious in their indication that a regulation has been violated, not all warning letters are considered equal,” said Mr. Mister. “If you look at the three main categories that these letters cover, the most egregious—and the one that consumers should pay special attention to—are the Warning Letters that address products that are marketed as dietary supplements, when in fact, they contain undeclared drug ingredients. I’m especially concerned by the products in this category and we’d urge consumers to avoid those products. We’d further urge FDA to quickly escalate its enforcement action for these products beyond the Warning Letter stage, as these products could be dangerous to consumers."
Mr. Mister further advised that because FDA does not always issue Warning Letters for products it has found to be adulterated—in some cases the agency instead uses other regulatory tools such as consumer advisories or product seizures—CRN recommends that consumers also check out a website created by the American Herbal Products Association, Keep Supplements Clean, which lists public notices of tainted products.
A second category of violations included in the database is letters alleging improper statements made in labeling or websites that claim to prevent, treat, cure or mitigate diseases. Mr. Mister urged consumers to be skeptical about these product claims and to talk with a health care practitioner before relying on these claims that could inappropriately raise expectations as to the product’s benefits.
The third category addresses more technical GMP violations that are discovered during FDA inspections, ranging from minor technical issues to serious gaps in quality. This category would likely be of little use to consumers, but would be of great interest to manufacturers trying to ensure they don’t receive an FDA Warning Letter following an inspection.
CRN’s FDA Warning Letters database is accessible through the association’s website. New Warning Letters are released by FDA every Tuesday, and CRN will update the database on a monthly basis.
