The Council for Responsible Nutrition’s senior vice president of scientific and regulatory affairs said the guidance had, “pulled a lot from the GMP preamble” he acknowledged few people had read.
His interpretation echoed that of Natural Products Association (NPA) scientific and regulatory affairs manager, Cara Welch, PhD, who stated the guidance designed to help smaller firms contained, “no surprises or omissions”.
“It is useful as it gives a strong idea of FDA thinking,” Dr Shao said. “And there is useful information there such as the need for expiration dates on products; the difference between a dietary supplement and a dietary ingredient; and some supply chain data.”
“But there is little detail about, for instance, how to confirm a Certificate of Analysis (CoA). This could simply be because the FDA believes the variability is so great that it cannot be specified in a guidance like this. Those waiting for specifics may be disappointed to know that it seems the FDA wants suppliers to figure it out for themselves. It won’t provide all the answers.”
Dr Shao said the fine line between a dietary supplement (which is governed directly by the GMP regulation) and a dietary ingredient (which is not) had been clarified somewhat. The end-design of the product was key, he said.
“If you are an ingredient supplier and you supply bulk – say ground ginger – and all the manufacturer does is repackage it, then the ingredient supplier could be deemed the manufacturer.”
The guidance did contain a CoA Q&A that provided information about the need to qualify, “the reliability of suppliers”, but, “didn’t do justice to the complexity of qualification”.
“It is a difficult position for the FDA to be in because the smaller businesses need a lot of hand-holding because they don’t have the resources, but it is clear the guidance will not provide all the answers.”
He said the FDA could go further, especially when the state of many facilities was revealed by early 483 FDA inspection reports.
“ If you look at the 483 inspection reports of facilities it is clear some companies are not doing any testing at all and they also cannot provide any rationale to defend why they are not.”
The FDA had expressed disappointment at how poorly many SMEs had performed, he said.