We are now more than a decade since the conclusion of the “reasonable discussion” resulting in finalization of the regulations concerning Good Manufacturing Practices for Dietary Supplements (Part 111 of Title 21 of the US Code of Federal Regulations). All companies involved in the manufacture, holding and distribution of food products also have concluded discussion resulting in final regulations concerning the manufacture of these products as well with the full implementation of Part 117 of the same title. This is not news by any stretch of the imagination and FDA, for its part, has been reminding companies of these facts by way of inspection observations (known as Form 483s) and warning letters issued to companies who are not in compliance. The facts are that after the rulemaking discussion, compliance in the realm of the manufacture, packaging, holding and distribution of all classes of foods are in effect. Your company’s compliance is under scrutiny and will be assessed either now or in the future by the regulatory agency. Ignorance is not an option and there is no other responsible party than you.

The second reality that needs to be discussed is the reality of enforcement which has been candidly uneven. This, in turn, has led to the current situation where the industry is uneven in the implementation of a decade old regulation regarding dietary supplements and is now falling behind in compliance for the manufacture of other food products. This comes along at the same time as the reorganization of the FDA which occurred last year. This resulted in the increased targeting of companies for inspection with Compliance Officers who were assigned based on their knowledge of the product category more than their seniority. Mix in the ever-deeper dive into the operations being inspected by the regulatory agency, and you have the makings of a very negative situation.

The enforcement activities in more recent days are more concise, insistent on compliance and the interpretation of what constitutes compliance while simultaneously being accelerated. It is not uncommon to have a slightly delayed response to a 483 result in a regulatory meeting with the FDA. Such meetings are another prelude to even greater potential action, including injunction and consent decrees. The regulatory agency is sending a clear message that they are most serious in their intent and they have begun to better manage the resources at their disposal.

The furthest intent of this information is to promote fear. The perspective here is that compliance is NOT an option. It never was. The understanding of what compliance really is continues to be the shortfall. This shortfall of either knowledge of the requirements or concern in the implementation of these compliant practices applies all through the supply chain. The manufacture of a dietary ingredient must conform to the regulations for the manufacture of a food product [Part 117]. The importation of a food product, whether or not it is a dietary ingredient, food additive, food product or other form of food is required to comply with the regulations out of the Food Safety Modernization Act (FSMA).The manufacture of any food product, including dietary supplements, must be performed in compliance with the applicable regulations [Part 111 or 117]. Packaging food products, as opposed to manufacturing and packaging, carries specific requirements out of the regulations in addition to the activities of performing the packaging operation. The warehousing, holding and distribution of food products and dietary supplements has specific regulatory requirements regarding procedures, plans, policies and performance. As far out on the supply chain as companies that are own-label distributors have regulatory obligations dependent on the activities they perform. An own-label distributor who never even has possession of the products, has regulatory obligations that must be fulfilled.

The awareness of these requirements is the focus of this presentation. Knowing that the regulations exist AND that they are applicable is the first step. The challenge to all companies is how to accomplish the task in the most efficient manner possible. Therein lies the real challenge. This can only begin with a full understanding of your regulatory obligations – what they are and what they are not. Identification of the gaps in your present systems is essential but the design of a compliant system is useless without implementation. The company must commit to compliance while ensuring that the commitment is one that may be met in the most efficient and cost-effective manner possible. Knowing where to gain the efficiencies while sealing up all of the gaps in compliance may require outside assistance. Regardless of how it is accomplished, it may only begin with an understanding of the obligations.

The passage of time has revealed a good bit of information regarding the focus of the FDA on matters of compliance with the regulations available. Learning from this data is essential to knowing how to continually comply in an ever-changing regulatory environment (yes, it does change owing to the nature of our regulatory structure) while performing in a sound, business practice environment. First, knowing what procedures you MUST have is an essential finding in the data from previous inspections. Anyplace along the supply chain exists an operation that requires procedures be in place by regulation. The performance in line with these procedures is the second most important requirement. This is not, as it would appear a “chicken and egg” thing. Performance in line with the established procedures demonstrates that the whole of the operation understands that everyone has a role to play in compliance. The demonstration of the understanding of the regulations is shown in the documentation the company holds, beginning with procedures and from those, the records, results and release documentation required. Ensuring that the establishment of these meaningful and applicable procedures, and, their implementation is the mandate for compliance. The fact is that individual companies have the ability to establish their own procedures that meet the operations performed. The compliance aspects serve as the skeleton for the system and the outline of the procedure but most importantly details that implementation are the keys to success. This begins again with knowing what the requirements are with clarity. The current inspections being performed show that the FDA is increasingly focused on deeper levels of detail in determining compliance with the regulations. Issues that were not previously noted are being routinely cited and demonstrates that “doing the minimum” means doing a lot more than what has perhaps been done. Performing in compliance is the other shortfall most be evident in the recent inspections. The actual implementation of the procedures developed becomes evident upon inspection and often serves as the entrée to the most current regulatory challenges.

A secondary, but no less challenging aspect of compliance involves the discussion of the products themselves. This is referred to as either labeling or advertising or both. The claims that may be made for these products are limited by the law and regulation. These claims range from the simple to the complex and often touch on the unacceptable. The verification of many of the claims presented, the acceptable ones, is an additional need. Accomplishment is often through testing and such testing can be expensive. Ongoing testing, owing to the claims made, may additionally be a requirement that may incur additional cost directly related to the product. This is applicable to ingredients and food products, along with dietary supplements. Claims that pose regulatory challenge are often the cause of warning letters. The presentation of claims whether from an ingredient supplier to their customer or onward through to the consumer, all fall under regulatory compliance requirements. Once more, solution is knowledge of the requirements and implementation of the practices necessary, not necessarily procedures, to minimize the regulatory exposure.

Compliance is not an attractive word. The facts are, though, that whether it is attractive, it is a requirement. The understanding you have about what that requirement entails is the first, most critical item to attain. Knowing what your company’s requirements are under the regulations is mandatory in order to keep operating. The imposition of penalties and harsh actions are a reality. This applies to everyone in the supply chain at all levels. Compliance is not an attractive word but it is a mandate for your company in order to remain successful and even in business. We, as an industry, have had ample time to come to understand the regulations and to implement them. Reliance on uneven enforcement is not a sound long-term strategy and can result in very unfortunate actions taken by the regulatory agency. Yes, compliance applies to your operation and it is your obligation not only to the regulatory agency but to the people working at the company and ultimately the consumer that the products entering the marketplace conform to the requirements established to assure the safety of the food supply.