Leveraging FDA’s cGMPs and HACCP Regulations to Protect Your Company
By Josh Becker and Aaron Block
As Benjamin Franklin noted, and as countless authors have affirmed since then, an ounce of prevention is worth a pound of cure. That is the animating principle of two related sets of U.S. Food and Drug Administration (FDA) regulations affecting the food and beverage industry: current Good Manufacturing Practices (cGMPs) and Hazard Analysis and Critical Control Points (HACCP). Proactive compliance with those standards may minimize your exposure to contamination outbreaks, severe recalls, government investigations, and lawsuits. It is probably also good business in its own right.
Overview of FDA’s cGMP Regulations and Related Programs
Like many acronyms that emanate from Washington, the cGMP and HACCP programs impose a variety of complex obligations and “suggestions” on FDA-regulated industries like the food and beverage sector. But the gist is straightforward. These programs generally require companies to establish—and ensure compliance with—best practices in the manufacturing and distribution of food products.
The theory is that by baking many quality control measures into the production, distribution, and retail service chain, it will be easier to prevent food safety issues before they reach the consuming public. And, in the event they do reach the public, it will be easier to identify the problem, identify the affected items, and conduct a recall or enforcement action.
Some regulations are fairly specific, but much of what constitutes a sound process is left to industry norms and the circumstances of a particular operation. That degree of flexibility, however, does not mean the requirements are insubstantial. FDA takes a broad view of what constitutes good manufacturing processes, ranging from facility design and cleanliness, to testing, to production, packaging and distribution.
The consequences for lack of compliance can be severe. FDA’s rules are intended to ensure the safety of the food supply, which is obviously a first-tier priority for FDA and industry alike. Products that do not comply are deemed adulterated under the Food, Drug and Cosmetic Act, which prohibits their sale in interstate commerce, among other things. Those are obviously adverse designations with important consequences in terms of recalls, brand reputation, investigations and litigation.
FDA is aggressive about lack of compliance. Two recent settlements involving pharmaceutical manufacturers, who operate under a similar regime, netted the agency over 1 billion dollars. And senior Department of Justice officials have publicly stated that they expect enforcement to be a major priority in the future.
Proactive compliance can minimize exposure to severe issues and collateral consequences. In principle, vigorous quality controls should reduce the risk of issues on the front end, or at least minimize them before they become widespread.
Compliance also has risks, though. The job of an investigator or plaintiffs’ attorney is considerably easier if a company fails to meet its own written standards. Put another way, drafting the world’s best compliance plan will do nothing to help if it is not followed, and if it is unrealistic then failure to comply with it will look bad to anyone evaluating the company’s conduct. There are recent examples of companies that allegedly fell short of complying with their own plans, with costly results, which means that compliance programs should be thoughtfully designed, carefully implemented and critically evaluated for revision as circumstances warrant.
Suggested Next Steps
If your company is among the 25 percent of the U.S. economy regulated by the FDA, chances are you have a cGMP, HACCP and/or related plan in place. A good first step is to ensure that your plan meets the current FDA (and any state) requirements and makes sense in the context of how your company actually does business. You also may want to consider ensuring the appropriateness of your preventive controls, which often can be considered to include (i) training, (ii) audits, (iii) documentation and (iv) validation/evaluation.
This can be an opportunity to add value by engaging with your technical colleagues about where potential issues are likely to arise, as well as what can and should be done to identify them in advance or as soon as possible. And think through the plan in event an issue arises, starting with how your organization will identify the root cause and affected goods. Product quality issues happen; advance planning and cGMP/HACCP compliance can make them rare and manageable.
Josh Becker is a partner, and Aaron Block is a senior associate, with Alston & Bird LLP. They both practice in the firm’s Atlanta office, and focus their practices on the defense of companies in the food/beverage/supplement and drug/device industries.
> Categories: Regulatory: FDA, FSMA, HACCP