Joy Joseph, founder of Joy’s Quality Management Systems, spoke last week on the new Food Safety Modernization Act (FSMA) rules soon to be finalized. Joseph led a session on the topic at the Rocky Mountain Dietary Supplement Forum hosted by the consulting firm FDA Compliance Group in Boulder, CO.
Joseph said there are seven proposed rules under FSMA, two of which were finalized in mid September and are set to go into effect in late November. One of these pertains to animal food, the other to food for humans. The rule most of interest to dietary supplement companies is the Current Good Manufacturing Practice and Hazard Analysis and Risks Based Preventive Controls for Human Food - Part 117.
Ingredient suppliers fall under new rule
According to a briefing conducted by FDA earlier in September, dietary supplement companies are exempt from this rule, as they are already required to comply with GMPs specific to their operations. But dietary ingredient suppliers, who up to now fell outside the purview of the Part 111 dietary supplement GMPs, will now have to comply with Part 117.
“Part 111 was specific to dietary supplement companies,” Joseph said. “There were no definite rules for ingredient suppliers, no controls to ensure those products’ quality. Dietary supplement manufacturers were responsible for making sure raw material suppliers were meeting their specifications.”
This change will fill in a gap that many have remarked on with a sense of consternation in the years since the GMP rule was finalized. The way this was apparently supposed to work was the manufacturers, in setting product specifications and conducting identity and purity tests on incoming raw materials as they are required to do under GMPs, would ensure a base level of safety for incoming ingredients. A number of the manufacturers who were in attendance at last’s week’s meeting said that in practice this has meant that too much of the burden falls on them for policing the activity of suppliers, some of whom have appeared all too happy to kick that particular can down the road.
The new rule will replace 21 CFR Part 110, Joseph said, with an aim toward adopting a more prevention-based approach toward food safety. The new rule includes the requirement for formulating and adopting a Hazard Analysis and Risk Based Preventive Controls plan.
“You will have to have a food safety plan and any old person cannot write that plan. You will have to have a person qualified in hazard prevention in foods,” Joseph said.
That plan would need to adopt a process control flow chart approach to look for points of risk, Joseph said. That includes risk of biological contamination from microbes or larger pests, chemical contamination such as from allergens or radiation, and physical contamination such as wood, rocks, plastic or metals from packaging or degrading machinery, etc.
About 15% of the US food supply is imported, Joseph said. The percentage of overseas ingredients used within the dietary supplement industry is even higher. Subpart G of the new Part 117 rule specifically addressed foreign operations, and is the source of some blurring of lines of responsibility. A definition in the rule of what is meant by a “receiving facility” will need some clarification, she said.
“Is the dietary supplement manufacturer who imports an ingredient the ‘receiving facility?’ Or does that pertain to the overseas supplier, who receives raw materials in their facility?” Joseph said.
The new rule also includes a Foreign Supplier Verification Program (FSVP). This is a program of expanded overseas on site audits of food facilities that send food (and by extension dietary ingredients) into the US. In recognition of the potentially heavy burden this could place on an already overextended agency, Congress also included a Qualified Auditor Program, in which FDA would accept audits of foreign facilities conducted by overseas governments whose food safety regimes are deemed to fall sufficiently in line with FDA’s own. The agency currently accept audits conducted by New Zealand, and is close to accepting those conducted by a number of other governments, but much more needs to be done, Joseph said.
Time to get prepared
Joseph said it is imperative that all dietary supplement companies familiarize themselves with the new FSMA rules, even if some of these changes might not affect them directly.
“At the end of the day, have the responsibilities of dietary supplement manufacturers increased or decreased? I would argue that under FSMA things will be a little bit easier for these companies,” Joseph said. “But you are still going to have to make sure your foreign suppliers are compliant with the FSVP, and that your domestic suppliers are complying with Part 117. We have had GMPs in place since 2008 and FDA says the industry is still not compliant. So I think dietary supplement companies need to get ready and be prepared, and not wait to find out that a shipment has been detained at the border because their supplier is not compliant.”