New York State Attorney General’s investigation has sparked a coalition of states attorneys general to form investigations against herbal supplement manufacturers.
Taking herbal supplements seems harmless on the surface; after all, they are “safe” and “natural.” Many people would not think twice about taking ginkgo biloba to improve their memory or ginseng to improve their overall health and boost their immune systems. However, last month’s announcement by New York Attorney General Eric Schneiderman tells consumers to beware. According to Schneiderman, mislabeled supplements can be a danger to people who take certain medications or who have serious food allergies.
This week, it was announced that U.S. attorneys general are taking the herbal supplement industry to task. The coalition of attorneys general that will launch investigations aimed at the marketing claims made by the industry, in particular the authenticity and purity of the supplements, include Connecticut, Indiana and Puerto Rico.
On February 2, 2015, Schneiderman issued cease-and-desist letters to the four major retailers alleged to be selling store brand herbal supplements in New York that either could not be verified to contain the labeled substance or were found to contain ingredients not listed on the labels. The products tested included gingko biloba, St. John’s wort, ginseng and garlic.
The cease-and-desist letters were sent out after DNA testing by the New York Attorney General’s Office allegedly showed that only 21 percent of the store-brand herbal supplements verified DNA from the plants listed on the products’ labels. According to the Attorney General’s office, a large number of the tests did not reveal any DNA from a botanical substance of any kind. They claim some of the contaminants found in the supplements include rice, beans, pine, citrus, asparagus, primrose and wheat.
On March 10, 2015, the coalition of state attorneys general stated that more than half of the FDA’s Class 1 recalls (products with a high risk of serious health effects or death) from 2004 to 2012 were for supplements.
One of the retailers that has been targeted has challenged the New York Attorney General’s testing methods and has commissioned an independent third party to test its supplements.
In addition, Schneiderman’s allegations have sparked a slew of proposed class actions against four major retailers.
The takeaway from this investigation is that retailers and manufacturers must prepare to defend themselves. They should take steps to ensure they have maintained accurate records of manufacturing practices, standards and procedures followed; adverse reports related to the product; and evidence that the manufacturer complied with current practices for quality control. It is important for retailers and manufacturers to have these records available before issues arise. The companies also need to make sure that they have complied with all regulations and have the testing records in order in the event a lawsuit is filed.