The American Herbal Products Association (AHPA) has updated its Slack-Fill Guidance to help the regulated supplement industry inform consumers and comply with all relevant federal requirements.

This guidance was originally published in November 2016 and has been reorganized and edited for clarity, with one substantive revision in the discussion on “Label statements and fill lines” in section 2.2.2.

In addition, more attention is provided to several somewhat obscure regulatory exemptions, as identified in section 1.1.3.7., and two appendices have been added to provide additional relevant information.

“A number of factors, often outside a company’s control, can cause a gap between a package’s capacity and the actual amount of the product inside,” said AHPA President Michael McGuffin. “It is important for companies to understand these factors and what they can do to mitigate them so customers know how much product they are purchasing.”

The U.S. Food and Drug Administration (FDA) regulates how food (including dietary supplement) containers are filled to prevent the use of partially filled or oversized containers that could mislead consumers about the actual quantity of food they are purchasing. The difference between the actual capacity of a container and the volume of product inside is called “slack-fill.”

FDA promulgated a final slack-fill rule in 1993 to “remedy the inadequate implementation” of the federal law concerning food containers that may mislead consumers. FDA clarified that the rulemaking “[was] not intended to authorize actions against companies that fill packages as full as practicable in compliance with good manufacturing practice.”

AHPA’s guidance provides best practices for industry to help companies ensure that packaging accurately informs consumers about the quantity of product in containers and comply with relevant federal regulations.

The guidance is organized into three sections:

• Section 1: Slack-Fill Law, Regulation and Enforcement provides legal and regulatory background, including details on regulatory exemptions to the definition of “nonfunctional slack-fill.”
• Section 2: Is the Slack-Fill Functional? discusses the rule in detail with particular attention to the key issues of the amount of empty space in a container and how the quantity of the contents of a food package are communicated to the consumer,
• Section 3: Practical Considerations provides basic questions for a packager of food and dietary supplement products to consider to evaluate compliance with federal slack-fill regulations.

For more information, visit http://ahpa.org.