FDA conducts a complex evaluation on a case-by-case basis to determine whether a liquid product is labeled appropriately as a dietary supplement or is “represented” as a conventional food, and will publish a guidance to help its staff and manufacturers distinguish between the two.

That document could lead to a broader guidance for navigating the conventional food/supplement line in general.

In an Aug. 10 letter responding to Sen. Dick Durbin’s questions about the regulation of energy drinks, FDA Assistant Commissioner for Legislation Jeanne Ireland said the agency is preparing a final guidance on distinguishing liquid supplements from conventional beverages.

The agency expects that final guidance “will help both FDA and industry draw a line between beverages and liquid dietary supplements. If this expectation is realized, we will consider issuing guidance on the demarcation between other types of conventional foods and dietary supplements,” Ireland wrote.

The draft liquid supplements guidance issued in December 2009 narrows FDA’s definition of what types of products qualify as supplements, and prompted industry stakeholders to speculate that the agency eventually could apply the same logic to other food categories and supplement formats Also see "FDA Supplement Beverage Guidance May Open Can Of Regulatory Worms" - Pink Sheet, 14 December, 2009..

In an April letter to FDA, Durbin urged the agency to clarify the definition of conventional foods and its authority to oversee the safety of food products that contain supplement ingredients. The Illinois Democrat, a frequent critic of FDA’s oversight of the food and supplement industries, asked the agency to act against high-caffeine energy drinks following the December death of a Maryland 14-year-old who suffered a cardiac arrhythmia after consuming two 24-ounce Monster Energy Drink products Also see "In Brief" - Pink Sheet, 9 April, 2012..

“Confusion” Under DSHEA

Ireland pointed out the Dietary Supplement Health and Education Act allows similar products to be labeled either as foods or supplements, complicating FDA’s regulatory oversight of supplement labeling.

“In our view, a major reason for the confusion between product categories is the statutory language that distinguishes a dietary supplement from a conventional food,” Ireland wrote.

DSHEA defined supplements in part as products “not represented as” conventional food in the Food, Drug & Cosmetic Act, striking a reference to supplements as not “simulating” conventional food.

Agency officials, Ireland said, “generally must consider multiple factors to determine whether or not a product is ‘represented’ as a conventional food.”

“This is a more difficult standard for FDA to meet, as it necessitates complex evaluation of the different ways in which a product can be ‘represented’ as a conventional food in labeling, advertising, or by other means such as packaging and product placement,” she added.

The director of FDA’s Division of Dietary Supplement Programs, Dan Fabricant, said by limiting the classification to the “not represented as” question, more evaluation is necessary to determine how a product should be labeled.

“For ‘simulated,’ the meaning is effectively, it looks like something,” he said in an interview.

“Whereas ‘represented as’ can have a lot more different connotations. In this context, is it marketed the same way? Are the statements made about it similar? Its physical appearance, its packaging – there are a lot of different issues that go under ‘represented as,’” Fabricant added.

Fueling Durbin’s Cause

The assistant majority leader, in his third term in the Senate, could use Ireland’s statements on the sometimes blurry line between nutritional products and conventional food as fuel for another proposal to tighten regulations for supplement manufacturing.

Durbin will look closely at FDA’s response and “will continue working with the FDA to protect consumers and ensure that they have all the information they need to avoid products that may pose potentially serious health risks,” a spokeswoman for the senator said.

Durbin in July 2011 introduced the Dietary Supplement Labeling Act, S.1310, to define conventional food and clarify how products should be regulated as foods or supplements, which he said have a "less stringent safety standard," and require firms to place warnings on labels about potential adverse event risks, list a batch number to facilitate recalls and register their products with FDA Also see "Durbin Bill Would Narrow Definition Of Dietary Supplement" - Pink Sheet, 4 July, 2011..

Industry stakeholders oppose most components of the bill, particularly the registry requirement, which they expect could lead to a requirement for pre-market review of products. Moreover, they argue that labels and ingredient lists change so frequently that a registry would quickly become outdated.

Durbin’s S. 1310 has not moved since it was referred to a committee, and in May he failed to win approval for proposed amendments to FDA user fee legislation to impose the requirements of his bill ([A#05120528011]).

The senator’s spokeswoman said he will continue to work on changing supplement labeling requirements, but also work “to ensure that the FDA has the tools it needs – and can use them effectively – to respond quickly and efficiency when safety concerns about dietary supplements – including those contained in energy drinks – arise.”

Liquids: Highlighting The Problem

The energy drink niche underscores the challenges of distinguishing foods from supplements. Some are marketed as beverages and others as supplements.

FDA can challenge a firm’s decision to label a product as a supplement or a food, based on “evaluating individual products on a case-by-case basis,” Ireland said.

Under regulations FDA enacted under DSHEA, “a manufacturer of a product in liquid form may choose whether … to label a product as a conventional food with a Nutrition Facts label or as a liquid dietary supplement with a Supplement Facts label,” she explained.

Additionally, manufacturers using caffeine – or other substances that mimic its effect – in supplement products are not required to submit a new dietary ingredient notification to FDA before marketing if the ingredients were common in the marketplace before DSHEA was passed.

However, caffeine’s generally recognized as safe status for use in some food products does not “automatically give GRAS status to other uses,” Ireland wrote.

Through this distinction, FDA could bring enforcement action against marketers of beverages with caffeine in excess of 200 parts per million, the level the agency set when determining GRAS for use of the ingredient in cola-type beverages.

“There are rules on both sides of the fence” separating supplements from food products, Fabricant pointed out.

However, moving products from supplement to food labeling often moves them into compliance.

“There are different paths to market and we want to be clear on that issue,” Fabricant said.

Ireland pointed out while energy drinks contain a range of caffeine levels, an FDA assessment of U.S. consumers’ ingestion of caffeine determined that “even when the consumption of energy drinks is considered,” the ingredient primarily is consumed in coffee and tea.

Available information from an ongoing agency review of recently published caffeine safety studies does “not indicate any new, previously unknown risks associated with” consumption of the ingredient, according to the letter. However, FDA bases its safety evaluations of all food and drug ingredients and medical devices on current scientific knowledge and will change “its regulations if new safety information becomes available.”

Ireland pointed out FDA enforced against Rockstar Inc.’s energy drinks this year and Innovative Beverage Group’s calming beverage drank in 2010. The agency sent warning letters advising the firms that their products were marketed inappropriately as supplements, a distinction that could render the products adulterated because each contains an ingredient that is not GRAS for conventional food Also see "Regulatory News In Brief" - Pink Sheet, 2 July, 2012..

The assistant commissioner noted that labeling that refers to a product as a supplement and includes a Supplement Facts panel for nutrition information does not make the product a dietary supplement if it otherwise is represented as a conventional food in labeling, packaging and appearance.

FDA in 2010 also sent warning letters to four firms marketing alcoholic energy drinks, prompting a nationwide halt to sales. The warnings followed the agency’s 2009 requests for information supporting GRAS status for the use of caffeine in the products Also see "Four Alcoholic Energy Drink Warnings Should Shake Up The Market – FDA" - Pink Sheet, 29 November, 2010..

In response to Durbin’s request that FDA consider the safety of other ingredients common in energy drinks – taurine and guarana – Ireland said the agency has not formally assessed them, but noted the European Commission concluded that taurine’s safety as an energy drink ingredient is not established.

Guarana is an approved conventional food flavor additive in the U.S. FDA has not approved taurine as a food additive, but the Flavor and Extract Manufacturers Association of the U.S. considers it GRAS for flavor use. As supplement ingredients, both are exempt from NDI notifications because they were in use pre-DSHEA.

FDA Works To Clarify Supplement/Food Distinction In Durbin Response

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