Explore all the latest packaging trends, all at PACK EXPO International
Discover new packaging and processing solutions from 2,500+ exhibitors, all under one roof at PACK EXPO International, Nov. 3 – 6 in Chicago.

FDA's subtle supplement message

Agency pushes ‘gently’ to achieve more accurate information on dietary supplement product labels.

After taking an essentially hands-off approach to dietary supplement labeling during President Bush’s first term, the Food and Drug Administration is suddenly all over the industry like an octopus. In November, the agency published an overall regulatory strategy that included some controversial initiatives in the area of labeling.

For the first time since the passage of the Dietary Supplement Health and Education Act of 1994, the agency published a draft guidance document that describes the kind of scientific substantiation—“competent and reliable scientific evidence”—a company should have for the “structure/function” claims on product packages. No evidence standard had ever been spelled out before, though companies are supposed to have substantiation for the claims they make.

In addition, the agency “highlighted,” in the words of Susan Walker, director, division of dietary supplement program, the existing requirement that supplement distributors disclose all “material facts” on their labels.

In an interview, Walker declined to get into a discussion of whether material facts are being left off too many labels. “But that is clearly one label element that could be explored voluntarily by supplement manufacturers and in an enforcement sense by the FDA,” she explained.

Asked whether the FDA was trying to send a particular message with its labeling initiatives, Walker answered, “We want to see accurate labels on products. Inaccurate labels should be corrected or removed.” About 69% of supplements carry claims on labels, most of them related to structure or function, according to the FDA.

Product claims

Structure/function claims were authorized under the DSHEA. Dietary supplement manufacturers do not need to obtain FDA approval prior to marketing a product and designing a label with structure/function claims. If a dietary supplement label includes such a claim, it must state in a "disclaimer" that FDA has not evaluated the claim.

New e-book on Multipacking and Case Packing
Read how to extend the life of your case packing equipment and best practices for efficient shrink bundling operation. Plus, learn the differences between wraparound & regular slotted containers.
Read More
New e-book on Multipacking and Case Packing
Check out new technology from 2,500+ packaging & processing suppliers
PACK EXPO International is where you can discuss real-world problems with experts and land on innovative ideas. Discover every new packaging and processing trend, see machinery in action and learn sustainable solutions from experts.
Read More
Check out new technology from 2,500+ packaging & processing suppliers