In 2011, the Food Safety Modernization Act (FSMA) was signed into law. At first glance, looking at the word “food" and evaluating the purpose for the passage of this new law, most stakeholders failed to see the overarching reach that expands across the entire food industry, not just conventional foods.
By law, food is defined as (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such articles. Even though dietary supplements are clearly defined as foods in the law, rarely do stakeholders or consumers think of dietary supplements in the same category as foods.
When FDA passed the dietary supplement cGMP (current good manufacturing practice) regulations, it enhanced the true separation between conventional foods and dietary supplements even though both meet the regulatory definition of foods. Foods are currently regulated under 21CFR Part 110, which focuses on sanitary manufacturing practices to prevent food adulteration, hence food borne illnesses.
Dietary supplements in 2007 were removed from the Part 110 regulations and transferred to a new regulation, 21 CFR Part 111, in recognition of the similarities between dietary supplement dosage forms and pharmaceutical dosage forms. Both of these categories must be manufactured to meet specific label claims with exacting specifications and requires verified measurements to ensure that specifications have been met. Record keeping is also required to ensure batch to batch integrity and to provide evidence that all requirements have been met.
Now, in 2011, FDA proposed new rules as a result of FSMA that will provide a proactive rather than reactive approach to control a safe food supply chain. Spelled out in the proposed rule is an exemption for dietary supplements because they must comply with 21CFR Part 111. It was also represented in the proposal that ingredient manufacturers may be allowed an exemption if they are also compliant with Part 111. This exemption would preclude ingredient manufacturers from compliance with the proposal for “Hazard Analysis and Preventive Controls for Human Foods." Currently, ingredient manufacturers are not required to comply with 21 CFR Part 111 for dietary supplements, but with 21CFR Part 111 for conventional foods.
While some products of the dietary supplement ingredient manufacturers may fall into a category where Part 111 may be applicable, it is not all inclusive. Many common and conventional foods are also used as ingredients in dietary supplements where Part 111 is not feasible or specific enough to control food borne health hazards without the implementation of more specific preventive controls that include hazard analyses, monitoring and validation. An ingredient manufacturer could distribute an ingredient of the same batch or lot, partially to a conventional food company and another part to a dietary supplement manufacturer. As noted above, two different regulations are involved.
Also impacting the ingredient manufacturers that supply the dietary supplement and food industries will be the proposed rules for Foreign Supplier Verification Program (FSVP) and the Certification of Third Party Auditors Program. The proposed Food Defense and Sanitary Transport regulations will tangentially affect the dietary supplement industry, but will be addressed in a future presentation.
Because more than 50 percent of the ingredients used to manufacture dietary supplements, botanical and non- botanical, come from foreign supply, it will require strategic oversight from companies to ensure their foreign suppliers are compliant with the U.S. safety requirements.
In the proposed rule, FDA has placed the responsibility for foreign supplier compliance upon the importers. Importers will be required to review the compliance status of the food and the foreign supplier before importing the food and periodically thereafter. They would be required to analyze the hazards associated with each food they import.
The rule again states modified requirements and exemptions for importation of dietary supplements and dietary supplement components; however, no clear line can be drawn as to what these modifications will be.
The bottom line is that finished dietary supplements are required to have FSVP in place to be imported into the United States, and ingredient manufacturers will need at least third party oversight to ensure food safety plans are in place and have been verified to provide the same level of protection as those required under the preventive controls. They must also verify the ingredients are not misbranded regarding allergen labeling.
Finally, the proposed rule for FDA accreditation of third party auditors or certification bodies is intended to support FDA’s mandate from Congress to increase the frequency and foreign supplier inspection. This rule would also facilitate the Voluntary Qualified Importer Program (VQIP), which will serve to expedite review and entry of food into the United States. Whether dietary supplement manufacturers and distributors will be accessing the resources of third party auditors, the program could well serve to provide the necessary information regarding supplier quality and could potentially serve to reduce resources needed to perform these inspections.
All foods will be impacted by FSMA. Food manufacturers in all categories need to be fully trained on FSMA and how these rules may impact their organizations. Otherwise, the lessons will be taught through border detentions, recalls and the inability to bring in much-needed materials to service customers and consumers.
Joy A. Joseph, president, Joys Quality Management Systems, specializes in implementation of the dietary supplement cGMPs (current good manufacturing practices) through training programs and facility auditing. As a consultant to the dietary supplement industry, Joseph is primarily concentrating on implementation of the new dietary supplement GMPs and offers expertise in formulations and regulatory affairs for foods, drugs and dietary supplement products.
Looking for more information on Food Safety?
Joy Joseph will present in the panel discussion “Food Safety: Processes to Control, Correct and Prevent Food Adulteration" as part of the Food Product Design track in the SupplySide West Education Program. The session will take place on Thursday, Oct. 8, from 2 to 4 p.m. at Mandalay Bay in Las Vegas. Visit west.supplysideshow.com/panel-discussions.aspx for more information and to get registered.