Dietary Supplements under FSMA

– Today we’d like to talk about FSMA and dietary supplements, and the purported exemption
that applies to them. Now, if you think about this, and you’ve asked yourself in the industry, does FSMA apply to dietary supplements, most people will probably say, “No, no, no, no, they’re exempt.” That’s not true. The fact is, FSMA applies
to raw material suppliers for dietary supplement manufacturers, and even the finished
product manufacturers. Let’s see how this works. Under the Dietary Supplement
Health Education Act, FDA was given the authority to create dietary supplement good
manufacturing practices, which the agency did. They’re called dietary supplement GMPs. They’re like drug GMPs. But they only apply to
finished dietary supplements. But that doesn’t mean the raw
material was off the hook. No, suppliers of dietary
ingredients and other raw materials were subject to the regular food GMPs. Now, when you overlay FSMA, you see the exemption does not completely exempt dietary supplements. Rather, looking at the language, “Nothing shall apply to any facility “that is in compliance with section 402 g2 “and 761 of the FDCA.” This exemption only applies
to the finished products. And of course, only if the manufacturer is in compliance with those requirements. So first of all, it doesn’t
apply to raw materials at all. It doesn’t apply to dietary
ingredient manufacturers. It doesn’t apply, therefore, to importers of dietary ingredient manufacturers or any other components
of dietary supplements. The exemption is inapplicable to them. So how does FDA manage those now? Under HARPC and FSVP,
exactly like any other food. That, I think, is a part of this exemption that many in the industry don’t recognize, that just because you’re
supplying a dietary ingredient does not mean you’re exempt from FSVP. FDA would disagree with you because the reg and the statutes say otherwise. Now, for finished product manufacturers, it’s also true that the
exemption is somewhat limited. When you read the statute
and the regulations, the exemption only applies
to dietary supplement finished product manufacturers, as long as they’re in compliance with dietary supplement GMPs. So, if a facility is
not in compliance with dietary supplement GMPs, then the agency has the option to bring a case against that facility, based upon the violation
of dietary supplement GMPs. Or, in that case, that facility would be considered to be subject to FSMA. So the agency could also bring a case against the industry with that company for HARPC violations. Now, I had mentioned in various places that it’s easier for the FDA
to prosecute a HARPC violation than it is to prosecute the old, traditional food reg requirements, because all they have to do is show the failure to have a plan, and that brings in an
immediate prohibited act. So, it is something for even finished dietary supplement manufacturers to be worried about. Now, there’s another
wrinkle to this exemption. It’s not uncommon for one facility to manufacturer dietary
supplements as finished products, but also other foods. They might be conventional
foods, like shakes. Or they might be dietary ingredients that are used in the manufacture of their own product or
other people’s products. Well, when that happens,
that’s a mixed facility, and that facility will be subject to the Dietary Supplement GMPs, as well as HARPC, and if
they’re an importer, FSVP. So this exemption is a
little bit more complex than the other exemptions, and it certainly is not an
across the board exemption for the dietary supplement industry. Thank you for spending
a few minutes with us at We remain committed to
helping the industry and our clients understand and comply with these regulations as they’re
implemented by the FDA.

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