On Feb 5, 2015 I wrote a blog post, titled, Authenticity of Dietary Supplements in Question: A Recall in New York
, (link to blog post). Now, I have a part 2 of this story, in that the State Attorney Generals from the States of Connecticut, Indiana and Puerto Rico along with New York have formed a coalition to expand the herbal supplement industry investigation
(link to story).
The coalition is formed to increase the visibility of the dietary/herbal industry and to ensure that the products are authentic and pure and that they also adhere to marketing claims. In the article, Sean Moloughney (Editor) states that Eric Schneiderman (New York AG) has issued cease and desist letters to the retailers on Feb 2 and issued subpoenas to four product manufacturers on Feb 16 requesting documentation related to standard operating procedures, quality control measures, analytical testing, label claims substantiation, and adverse event reporting.
The documentation that Schneiderman requested fit within the guidance of cGMP requirements established by the FDA which each manufacturer is required to comply with. (Details on these requirements can be read in my first blog referred to in the opening sentence of this post.)
The U.S. FDA has implemented new current good manufacturing practices (cGMP) regulations (21 CFR part 111)
that mandate appropriate quality control and process control testing for dietary supplements, from incoming raw materials to finished goods (link to the FDA site). And, you might be aware that one of the most important analytical tools used in testing the quality of dietary ensuring standards of supplements is chromatography. We recently released an infographic, titled, Quality Control of Dietary Supplements
, (downloadable PDF) to provide handy information about this market and it features a link to a useful presentation reviewing what these new regulations mean to companies in regards to testing requirements and what types of chromatography systems are can be used to address the issue.
You might also want to check our Dietary Supplements and Nutraceuticals community webpages
for many more resources including the latest applications, on-demand webinars, changes in regulatory methods & more on this topic. Is your state or country considering regulating the authenticity of nutraceuticals? Tell us in the comments section; we look forward to hearing from you.