HBW Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Lawyers Working To Defog “Clouding” Of Food/Supplement Boundary

This article was originally published in The Tan Sheet

Executive Summary

FDA lawyers are taking a closer look at products marketed across the line between dietary supplements and foods, with special attention to beverages, according to Robert E. Brackett, head of the agency's food safety center

FDA lawyers are taking a closer look at products marketed across the line between dietary supplements and foods, with special attention to beverages, according to Robert E. Brackett, head of the agency's food safety center.

The agency is monitoring the "clouding of the conventional food/dietary supplement boundary," the Center for Food Safety and Applied Nutrition director said during an Oct. 4 presentation at the Council for Responsible Nutrition's annual conference in Scottsdale, Ariz.

"Here we're seeing, particularly in the area of beverages, where something may be listed as a conventional food when it truly is a dietary supplement and in some cases vice versa and we're going to have to deal with that in the future," he said.

"In that area, FDA doesn't really believe the law was intended for the purpose that is being done ... and what this has done now has actually caused our chief counsel's office to look very carefully at this as far as what the policy and the safety issues are for the agency."

"This is something that we will be making some decisions on in the next upcoming year," Brackett said.

FDA conducted a public hearing in December to gather information and comments on the regulation of functional foods, but has yet to issue any public guidance or additional regulation (1 (Also see "Functional Foods, Supplements Need Level Regulatory Playing Field – Experts" - Pink Sheet, 11 Dec, 2006.), p. 3).

At the meeting, multiple industry representatives pointed out that many of the concerns voiced about functional foods are focused on beverages, and energy drinks - which often contain caffeine - in particular (2 (Also see "FDA Should Require Food Labels Carry Functional Ingredient Data – Experts" - Pink Sheet, 11 Dec, 2006.), p. 4). Several trade groups and representatives showed support for required labeling of functional ingredient identity and quantity, including caffeine content.

Functional Foods Fuel Supplement Interest

Meanwhile, more mainstream functional food products are having a complementary effect on the conventional food and supplement markets, an executive panel said at the CRN conference on Oct. 6.

Functional foods and beverages are "having a positive effect" on the supplement business, said Vitamin Shoppe CEO Tom Tolworthy.

"It's helping fuel consumer interest at a high level, and that consumer interest leads to more knowledge, more information, and that knowledge and information lead to more sales," he said.

CRN President Steve Mister moderated the discussion, which featured Tolworthy, Natural Alternatives International President Mark LeDoux and NBTY President Harvey Kamil.

"I think it helps our business," LeDoux agreed. "Anything that makes people start thinking more about the quality of their foods is going to inure to our benefit, because once they see that the foods cannot possibly have all the nutrients that you need, they're going to start taking supplements and, to me, it's just so logical to continue this process of fostering the content of functionality of food."

Citing companies including vitamin D in orange juice, Tolworthy said the result is increased consumer consciousness about the health benefits of nutrients, rather than an erosion of supplement sales as people increasingly use functional foods.

"You draw attention to health and nutrition through the simple addition of vitamin D to an orange juice, and that gets the consumer thinking," he said. "The more information they find out about vitamin D and its uses, the more that leads to supplementation and somebody in our store seeking more advice and counsel on how that could have a positive effect on their lifestyle."

"It isn't plausible at this point as we look out at the business to say that within our customers that a functional orange juice is going to replace the way they see vitamin C's usage in their lifestyle," he said.

"So, if they see food being fortified with essential fatty acids, that makes them more interested in essential fatty acids, and they're coming in to buy fish oil," Mister suggested. "That's interesting that we don't see it as a threat but really that the two, functional foods and vitamins, can help grow each other's markets."

Kamil said he expects consumers will continue to "put more interest" in functional foods and beverages.

- Jessica Lake ([email protected])

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS138136

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel