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Is Your Supplement Company FSMA Compliant?

Category: Educational Articles

In a previous blog, we explained how the Food Safety and Modernization Act (FSMA), signed into law in 2011, grants the Food and Drug Administration (FDA) sweeping new powers to ensure public health and safety through preventative and proactive, rather than reactive, measures. The goal of the legislation is to combat contamination of foods and products made for consumption before they ever reach the public. The scope of the new regulations includes supplement manufacturers which must be FSMA compliant by the end of 2017 or 2018, depending on size. Will you be ready when the law kicks in? You should be.

What does the FSMA mean for supplement companies?

Supplement companies must be aware of how the FSMA rules may impact them. For example, the Foreign Supplier Verification Programs (FSVP) rule stipulates that the same preventive safety standards apply to food and supplements consumed in the U.S. regardless of where they are produced. Under FSVP, importers must verify that their foreign suppliers meet applicable FDA safety standards. Foreign ingredient manufacturers will need, at a minimum, on-site audits to verify the levels of protection required under these preventive controls. Importers must also verify that ingredients are accurately labeled for allergens. More than half of the ingredients used to manufacture dietary supplements come from abroad, so strategic oversight is needed to ensure their compliance with U.S. safety standards.

Is a manufacturer of bulk dietary supplements exempted from the preventive controls for human food?

FSMA’s preventive controls rule, 21 CFR 117.5(e), exempts finished dietary supplements from the requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111, and with adverse event reporting. This exemption is specific to these two elements of Part 117, and only applies to finished dietary supplements in bulk form. It does not apply to the manufacturing, processing, packing, or holding of dietary ingredients, which are subject to the rule. Furthermore, ingredient manufacturers are not required to comply with 21 CFR Part 111 for dietary supplements.

How will the revised Current Good Manufacturing Practices (cGMPs) affect manufacturers?

The revised cGMPs contain general provisions that apply to supplement manufacturers if not otherwise covered by Part 111. Only finished dietary supplement products are exempted from subparts C and G of Part 117. Ingredient manufacturers must comply with the revised cGMPs, and also implement preventive controls and a supply-chain program to ensure the integrity of dietary ingredients received by supplement manufacturers.

In a nutshell, the FSMA puts into place mechanisms which will prevent safety problems before they occur. Check out www.fda.gov/food/guidanceregulation/fsma for more information regarding these rules. Here at Deerland Enzymes & Probiotics, steps have already been taken to ensure FSMA compliance. If you would like to meet with an expert and learn more, contact us here!

About The Expert
Hope Hanley
Vice President of Quality & Regulatory Affairs, Deerland Enzymes & Probiotics

Hope has more than 10 years of experience as VP of Quality and Regulatory Affairs with Deerland Enzymes & Probiotics.

Hope Hanley

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