While much of the food world has been waiting anxiously for FDA to publish its new, human food safety rules – more properly known as regulations for “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food” (September 17, 2015) – most members of the dietary supplement industry have been more likely to say “hmmm?” than “OMG.” And they’ve had good reason, on a couple of levels: First, on principle; and second, for practicality.
Dietary supplement firms exempted
As to the principles of responsible manufacturing (here we depart from the orthodoxy of legions of consultants and lawyers) there are things on which we should all agree, regardless of product category. The Food Safety Modernization Act (or “FSMA”) (the legislation requiring the new regulations) calls-for consideration of questions which already should be on the minds of responsible food industry participants: Can I rely on my suppliers to ensure that my ingredients are safe? What kinds of things can go wrong during manufacturing, packaging and storage? Will consumers get sick if they do? How do I prevent them? Do my manufacturing processes (and the people who implement them) receive enough resources, oversight and evaluation? How – and how quickly – would we react if, despite all our efforts, something went wrong with our products and we have to get them back? Have I written any of this down?
The argument on practicality is even stronger. FDA’s new human food safety rules simply don’t apply, in important respects, to dietary supplement products. FSMA (the statute on which they’re based) makes this quite clear: “Nothing in the amendments made by this section shall apply to any facility with regard to the manufacturing, processing, packing, or holding of a dietary supplement” that otherwise complies with the law. FDA’s regulations specifically exempt dietary supplement companies from potentially the most troublesome provisions: Hazard Analysis and Risk-Based Preventive Controls (“HARPC”) and the Supply-Chain Program.
Dietary supplement manufacturers have already been facing their own, gradual upgrade of safety and quality legal requirements starting with the 2007 publication of FDA’s Current Good Manufacturing Practices for Dietary Supplements. Should we really expect members of the dietary supplement community to be particularly anxious, then, on behalf of their brothers and sisters in conventional foods? But, as might be expected in a guest lawyer’s column, there’s an exception to the general rule of dietary supplement FSMA-indifference. It comes in the form of dietary ingredient companies.
For historical reasons (which really means for political reasons and ultimately, perhaps, for economic reasons) the law has not treated dietary supplements and dietary ingredients equally. More than twenty years ago Congress gave FDA the authority to “prescribe good manufacturing practices for dietary supplements” (emphasis added). Some members of the public, when it came time to comment on FDA’s proposed rule for dietary supplement good manufacturing practices, argued strenuously that dietary ingredients should also be covered. But FDA was adamant: “Those who manufacture, package, label, or hold dietary ingredients are not subject to the . . . rule.” Instead, general food cGMPs would continue to cover dietary ingredients. According to FDA’s statement at the time, “if you manufacture, package, label, or hold dietary ingredients that will be further processed as a dietary supplement by another person, you must comply with food CGMP requirements in part 110” (emphasis added).
Ingredient suppliers fall under FSMA
That gap – the gap between the theoretically stricter requirements of cGMPs for dietary supplements and the food cGMPs for dietary ingredients – has been narrowed (perhaps eliminated) by FDA’s new rule. FSMA’s exception from HARPC requirements (“[n]othing in the amendments made by this section shall apply to any facility with regard to the manufacturing, processing, packing, or holding of a dietary supplement”), the agency points out, is limited to supplement products. There’s a nice irony in the consistency of the agency’s approach. FDA refused in 2007 to extend cGMPs for dietary supplements to cover dietary ingredients because, at least in part, Congress used the phrase “dietary supplements” in the underlying statute. Now, in 2015, FDA declines to exempt dietary ingredients from the application of HARPC and the Supply-Chain Program because, at least in part, Congress uses the phrase “dietary supplement” in FSMA’s statutory exemption.
Dietary ingredient manufacturers need to prepare to do two things (and dietary supplement companies must ensure that they do so). First, they should begin – or speed-up, if they have already begun – undertaking their “hazard analyses” in preparation for developing, implementing and monitoring risk-based preventive controls. Second, they should be looking ahead to the effective dates of their Supply-Chain Programs, especially as these will interact with new Foreign Supplier Verification Program requirements.
1. Hazard Analysis & Preventive Controls
Dietary ingredient manufacturers are required to conduct hazard analyses for their operations. This should be a structured and disciplined process and, fortunately, there are some helpful tools which companies can employ.
The hazard analysis seeks to identify “hazards” (biological, chemical or physical) which may occur in a dietary ingredient at every step in its manufacturing: receiving raw materials (the dietary ingredient facility is the “receiving facility”, e.g., receiving raw botanicals to be dried and powdered), processing / manufacturing, packaging and storing. Some hazards may even be weather-related – for example, the biological/chemical hazard posed by excessive levels of mycotoxins which are generated by molds during unseasonably wet conditions. The identified hazards must be evaluated, taking into consideration both: (a) the potential health severity; and (b) the likelihood that the hazard will occur if the company institutes no preventive control. An infrequent, but highly severe hazard, will require some preventive control(s); a frequent, but minor hazard, may not.
Preventive controls, commensurate with the hazards identified, must be designed, documented and evaluated. These may involve controls at critical points, processing controls and/or sanitation and hygiene controls. (The Supply-Chain Program and the company’s recall plan will also be considered part of its “preventive controls”). Dietary ingredient manufacturers are not required to implement preventive controls for every hazard, even those which are severe. The rules permit, under specific conditions, a company to rely on its customers to implement appropriate controls. Again, it is critical to the demonstration of compliance that companies identify and design preventive controls through a structured and disciplined process.
2. Supply-Chain Program / Foreign Supplier Verification
Dietary ingredient manufacturers who have been concerned about the interplay of supply chain preventive controls under the general “Supply-Chain Program” regulation and the Foreign Supplier Verification Program regulation (still under consideration and not yet final) can feel a sense of relief. FDA’s final rule for the Supply-Chain Program has been reconciled with the proposed FSVP rule so that, if an ingredient manufacturer is importing raw materials from abroad and complies with the forthcoming foreign supplier verification requirements, it need not conduct additional verification activities for that overseas supplier.
This leaves dietary ingredient manufacturers under the following basic obligations regardless of whether its suppliers are foreign or domestic: Using approved suppliers; determining how to “verify” suppliers (e.g., audits, testing, reviewing records); ensuring that supply-chain dependent preventive controls are actually being implemented and are effective; and adequately documenting all of the above.
Now, more than ten years after the adoption of stricter dietary supplement cGMPs, dietary ingredient manufacturers are also under a heightened “HACCP lite” level of performance. Dietary supplement companies (indirectly) and dietary ingredient companies (directly) all have an immediate interest in FSMA’s smooth implementation.