FDA’s General Safety Clause and Good Manufacturing Practice (GMP) Requirements

The StepLadder Series is a Steptoe publication focused on discussing food contact regulatory topics in plain language.

Does your packaging pass the sniff test?

Where does FDA’s General Safety Clause Come From?

Section 402(a) of the Federal Food, Drug, and Cosmetic Act (the Act) states that food shall not be introduced into interstate commerce if it is adulterated.¹ Adulteration is a legal term of art, and occurs when food "“bears or contains any poisonous or deleterious substance that may render the food injurious to health." The underlying principle of adulteration can, however, be easily understood with a healthy dose of common sense. Food is considered adulterated if, among other items:

• It contains a substance that meets the definition of a "food additive" under the Act but that substance is not the subject of an FDA clearance or authorization for that intended use.²
• It contains a substance that imparts an off-taste or odor to the food.³
• If the food is filthy, putrid, or otherwise such that you wouldn’t want to eat it for breakfast… or feed it to your friends.

Importantly, adulteration can occur both through the direct addition of an unauthorized substance to food, or indirectly, as a result of one or more unauthorized substances migrating from packaging to food. For this reason, the entire food and packaging supply chain, from raw material suppliers, to converters, to manufacturers of finished product (and even those companies that then transport the finished food or packaging for downstream use or consumption) share a common responsibility to ensure that food does not become adulterated at each stage of the lifecycle of the food and food packaging.

The adulteration provision of the Act (i.e., Congress' directive to FDA) is implemented by FDA (i.e., FDA’s directive to companies) with respect to food packaging in 21 C.F.R. § 174.5 ("General provisions applicable to indirect food additives"), which is commonly referred to as the "Good Manufacturing Practice" regulation. It states that food-contact materials must be of a "purity suitable for [their] intended use."⁴

How is Good Manufacturing Practice (GMP) Satisfied?

In promulgating the food additive regulations, including Section 174.5, FDA recognized that it would be challenging, if not impossible, to spell out specific requirements for every potential type of food packaging facility, material, method of manufacturing and operation. Therefore, FDA instead effectively places a minimum blanket obligation on the entire food packaging industry to do no harm, and to ensure a safe food packaging supply.⁵

The concept of self-regulation, in this instance, is neither unwarranted nor inefficient. At its core, a company's most important assets are – in no particular order – its brand, its product, its employees, and its customers. Should the brand come under scrutiny because of the negative impact of a significant and highly-publicized adulteration event, customer demand could instantly vanish, leaving the reputation of the product – and the company – in shambles.

To comply with GMP obligations under the Act, the minimum responsibility of any company is to do no less than is considered current industry standard to ensure the safety and suitability of food or food packaging. While "doing at least what others do" may sound somewhat unsatisfying, the reality is that GMP changes and evolves constantly, as new technologies are introduced to monitor product quality, safety, and oversight. A company’s determination as to whether GMP is satisfied depends just as much on corporate culture, economic considerations, and risk tolerance as it does safety procedures and policies.

The Value of Good Advice

Recognizing that companies are often loathe to invite their potential competitors into their facilities for a "show-and-tell" event, they must instead rely on other avenues to learn what the most efficient and effective practices are from both a safety and cost standpoint. Fortunately (and remembering to avoid engaging in activities that could run afoul of antitrust laws and obligations!), companies can expand their knowledge and improve their own GMP policies and procedures through a variety of other means, including:

• Attending trade association meetings and subject matter conferences.
• Evaluating new technologies and opportunities for standardization with upstream material and equipment suppliers.
• Engaging in constant communication with downstream customers (particularly insofar that customer requirements may well exceed the bare minimum of the "do no harm standard").
• Engaging external legal counsel to conduct periodic site visits and complete assessments of food packaging facilities, procedures, recordkeeping, and training.⁶ The selection of external legal counsel to conduct these activities is important to maintaining the confidentiality of such evaluations, discussions, and records of the same, under attorney-client privilege and confidentiality.

Factors to Consider

While the scope and extent of an external audit necessarily depends on a variety of factors, a successfully-implemented program should include at least the following activities, conducted uniformly, objectively, and consistently over repeated assessments:

1. A general evaluation of the external and internal cleanliness of the facility.
2. Assessment of access and security procedures.
3. An evaluation of roles, responsibilities, and priorities relating to product quality.⁷
4. A review of procedures – including manufacturing, quality, employee safety, training, and adverse event response.
5. A detailed evaluation of the all locations where product (or its components) will move throughout the facility, including, but not limited to: incoming storage, staging, manufacturing, quality inspection, finished goods storage, and shipping.
6. Training, education, and discussion of the importance of GMP to the employee, the facility, the product, the brand, and the consumer.

Periodic external audits should be supplemented with more frequent internal audits (both announced and unannounced) in cooperation with both in-house and external counsel.

Ultimately, the extent to which GMP is implemented depends on a necessary balance between regulatory compliance, economic considerations, and risk tolerance. This decision should not be made in the blind, however, and should be based on informed advice, education, and training.

¹ The Act also specifies that food shall not be introduced into interstate commerce if it is misbranded.

₂ The addition of substances that are cleared or authorized for another use, but are not permitted for the specific authorized use can render food adulterated, per se.

³ As a practical matter, adulteration can be subjective – wherein a an off-taste or odor from an otherwise-authorized additive may be more apparent in a flavorless beverage like water, compared to savory food held in packaging. Adulteration also can be objective, wherein an unapproved additive is present in the food regardless of the presence or absence of an off-taste or odor.

⁴ This StepLadder article focuses on those aspects related to manufacturing, recordkeeping, training, and auditing in the production facility. An upcoming StepLadder article will separately focus on satisfying suitable purity obligations for the product.

⁵ Note, however, that FDA does specifically prescribe significantly more detailed requirements for the production, importation, and transportation of food (as opposed to food packaging) under the Food Safety Modernization Act (FSMA), Pub. L. 111-353 (January 4, 2011).

⁶ Consistent internal auditing is important, as well, but beware the implicit bias and risk of blinders that comes with having your own personnel put in a position of reporting deficiencies in their own processes to those that manage, supervise, and evaluate those same employees!

⁷ Importantly, this includes the designation and identification of one or more individuals who are specifically responsible for responding to events that could result in an adulteration situation. These individual(s), their respective contact details, and procedures for addressing such events should be made known to all personnel.

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About the Steptoe StepLadder Series

Steptoe & Johnson LLP is pleased to publish the Stepladder series of articles for our clients, prospective clients, and interested companies as a way of educating attorneys and non-attorneys alike about legal and regulatory principles related to food packaging in meaningful ways. While there are many sources of information available online, the StepLadder series is intended to be accessible to, and understandable by all, to help support business decisions related to food packaging compliance.

This information is provided for educational purposes only, is not legal advice, and does not establish an attorney-client relationship with Steptoe. Our lawyers made us write that. If you have legal questions, please consult an attorney. Preferably from a team well-versed in food packaging regulation – and definitely from a group of attorneys that have a good sense of humor. Because you are what you eat… unless your food packaging isn’t a ‘food additive,' in which case you’re not food packaging.