FDA Reopens Comment Period on Proposed Labeling Regulations for “Conventional Foods” & Dietary Supplements

On March 3, 2014, FDA announced a proposed rule that would amend the regulations regarding the labeling of conventional foods and dietary supplements. In this announcement, the Agency sought feedback by asking the public for comment on its proposal.

According to FDA’s definition, a dietary supplement is “a product taken by mouth that is intended to supplement the diet and that contains one or more ‘dietary ingredients,’” which could include:

• Vitamins
• Minerals
• Herbs or other botanicals
• Amino Acids
• Other substances found in the human diet, such as enzymes.

FDA requires any product identifying as a “dietary supplement” to be labeled as such and cannot be “represented for use as a conventional food or as the sole item of a meal or the diet.” Conventional food products are different from dietary supplements and are required to have a “Nutrition Facts” panel on their label, whereas dietary supplements have a “Supplement Facts” panel. One way FDA says one way to differentiate between dietary supplements and conventional foods, is by looking at the labels of the respective products.

In July of 2015, FDA issued a supplemental proposed rule and reopened the comment period until September 25^th. The purpose of this was only to obtain comments on “two consumer studies being added to the administrative record.” Then on September 10, 2015, FDA issued a notice in which they clarified the following points:

1. “The consumer studies on the added sugars declaration and the alternative footnote statements in the supplemental proposal relate to topics on which we sought comment
2. The consumer studies on the format published in a separate notice in July 2015 were included for comment, and were placed in the docket at that time.”

FDA also stated in the notice that “in response to requests for the raw data for each of these consumer studies that are relevant to the summary memoranda for the studies,” it would be making the raw data available for comment as well. At that time, the Agency extended the comment period for the two consumer studies related to the proposed changes to the Nutrition Facts label formats (which was originally scheduled to close on September 25, 2015) to October 13, 2015, to coincide with the end of the comment period for the supplemental proposed rule.

However, on October 13 and 14, the Federal eRulemaking Portal experienced technical difficulties in which prevented the electronic submission of some comments. Because of this technical glitch, on October 20, 2015, in an announcement in the Federal Register, the Agency stated that the comment period for both the consumer studies and the supplemental proposal would be reopened until October 23, 2015.

If interested in providing the Agency with input on the proposed regulation, submit your comments here.

Do you have a dietary supplement or a conventional food product? We can help ensure that you are compliant with labeling regulations in addition to all other FDA regulations regarding these types of products. For more information on how we can help you, please contact us.