Legislation Sen. Dick Durbin offers to stop firms from allegedly side-stepping food safety standards by labeling products as dietary supplements could have a "devastating impact on the industry," stakeholders say.

The Illinois Democrat said June 27 that the Dietary Supplement Labeling Act directs FDA to define "conventional food" and clarify when products should be regulated as foods or supplements, which have a "less stringent safety standard."

The bill, which Durbin planned to introduce June 30, also would require firms to warn on labels about potential known adverse event risks, list a batch number to facilitate recalls and register their products with FDA.

The proposals are aimed at helping consumers "distinguish between products that are safe and others that contain potentially dangerous ingredients which haven't been approved by the Food and Drug Administration," Durbin said in a release.

But the legislation could have "unintended consequences" that could "ruin the marketplace for a lot of products," and "have a devastating effect on the industry," said Steve Mister, president and CEO of the Council for Responsible Nutrition.

United Natural Products Alliance Executive Director Loren Israelsen agreed. He said Durbin's “goal appears to be much bigger: to rewrite” the Dietary Supplement Health and Education Act, which allows firms to sell supplements without pre-market review by FDA.

Stakeholders Criticize Registry Proposal

The American Herbal Products Association explains in a June 28 release that "the most controversial part" of the bill might be the requirement that manufacturers register their supplements with FDA and provide product descriptions, lists of ingredients and copies of the labels.

The bill could have "unintended consequences" that could "ruin the marketplace for a lot of products," and "have a devastating effect on the industry." – CRN President Steve Mister

The registry would allow FDA to inform manufacturers of possible safety concerns and know how many supplements contain certain ingredients, Durbin says.

The senator has sought this change in the past, and some in the industry worry a registry could lead to pre-market review or create a model similar to Europe's or Canada's (Also see "Suggested Supplement Registry To Root Out Spiked Products Sparks Debate" - Pink Sheet, 18 October, 2010.).

Health Canada requires firms to register natural health products, demonstrate they meet specific quality and safety standards, adhere to efficacy claim standards and obtain approval prior to marketing (Also see "Canada Proposes Temporary Expedited Approval For Natural Health Products" - Pink Sheet, 21 June, 2010.).

Supplement Labeling Act Requirements

FDA defines "conventional foods."
Firms warn consumers about potential known adverse events and risks of product ingredients.
Labels include per-serving weight of proprietary blends that FDA determines pose potential risks when consumed in excessive amounts.
Manufacturers register supplements with FDA, providing product descriptions, ingredient lists and label copies.
Supplement packages include batch numbers.

AHPA noted in its release that its "primary focus will be on identifying and opposing any legislation that in any way reduces consumer access to safe dietary supplements."

Even if the registry does not lead to pre-market review, it might not be a good idea, Israelsen said. He notes pilot programs of supplement registries show labels and ingredient lists change so quickly that a registry would be out of date and not helpful.

Durbin's bill outlines when and how firms should update the registry if their products are changed or discontinued.

Warning Requirement Raises Red Flag

The requirement in the bill that firms warn consumers if a product includes an ingredient that could cause a known adverse event is more concerning to CRN than the registry, Mister said.

"I am worried about the labeling provision being the slippery slope into pre-market review because that is the way for FDA to require all kinds of labels of supposed harms and concerns on products," Mister said.

He explained firms would either have to make the label changes or remove their products from the market, thus creating a "pre-market review situation."

The bill gives FDA one year to compile a list of supplement ingredients and proprietary blends that "could cause potentially serious adverse events, drug interactions, contraindications or potential risks to subgroups such as children and pregnant or breastfeeding women."

The Institute of Medicine would then have 18 months to evaluate the ingredients and blends and confirm potential risks, about which FDA would have another two years to write mandatory label warnings that firms would have to include on packages.

CRN worries that "IoM could get into areas that are not a real risk," and require "labeling for a possible health risk that may be very attenuated or may be experienced only by a very small segment or subpopulation of people who would take the product," Mister said.

For example, recent studies suggest calcium supplementation could increase the risk of kidney stones. Mister said he could "easily foresee the Institute of Medicine grabbing a hold of that study, making a big deal out of it and saying you need to warn people about kidney stones."

Durbin’s approach applies "far too much legislative horsepower to a problem that does not lend itself to statutory regulation." – UNPA Executive Director Loren Israelsen

Such "exaggerated concerns" and warnings could crowd product labels and drive consumers out of the marketplace, Mister said. "This could be a way to really ruin the marketplace for a lot of products."

Mister acknowledges these likely are "unintended consequences" and not Durbin's intention.

Indeed, Durbin says his "gripe is not with the array of vitamins available in health stores," and that "most products labeled as dietary supplements are legitimate health aids."

Rather, he said, his "gripe is with products containing potentially dangerous additives, labeled as 'dietary supplements' and marketed to young adults who find them on store shelves right next to conventional food and beverages whose ingredients have been deemed safe by the FDA."

For example, Durbin said, energy drinks labeled as supplements and heavily marketed to young adults "are being taken in large doses by consumers who aren't aware of the potentially dangerous side effects."

Other high-risk groups that would benefit from warnings include pregnant women, children and people with conditions such as diabetes or high blood pressure, Durbin said.

Energy Drink Concerns Fuel Bill

While the act would impact all supplements, Durbin's primary concern appears to be with beverages, as he specifically calls out several in his release, including the energy shot 5-Hour Energy and the calming drink drank, which contains melatonin.

"Products that contain potentially unsafe additives" are on store shelves "right next to beverages that have undergone FDA approval" and consumers "aren't easily able to tell the difference," he said.

These concerns echo those he expressed in a letter sent May 18 to Commissioner Margaret Hamburg about melatonin-containing baked goods, such as Lazy Cakes, Kush Cakes and Lulla Pies that are marketed as dietary supplements but resemble snack foods (Also see "Melatonin Snacks Prompt Durbin Questions On Dietary Ingredients in Food" - Pink Sheet, 23 May, 2011.).

Durbin uses these products as examples of why FDA must define "conventional food" and make other regulatory changes.

Durbin’s approach, though, "is applying far too much legislative horsepower to a problem that does not lend itself to statutory regulation," but rather would benefit from enforcement of existing laws and guidances, Israelsen said.

For example, FDA gets at part of the energy drink problem with a 2009 draft guidance that differentiates between liquid supplements from conventional drinks. The draft discourages firms from describing liquid supplements with phrases such as "drink" and "juice" or using packaging similar to containers for sodas, fruit juices or bottled water (Also see "FDA Supplement Beverage Guidance May Open Can Of Regulatory Worms" - Pink Sheet, 14 December, 2009.).

Shortly after publishing the guidance, FDA reinforced its position by sending a warning letter to Innovative Beverage Group for including melatonin in drank. The agency said melatonin is not generally recognized as safe for use in conventional foods, even though drank is labeled as a supplement (Also see "FDA's Drank Melatonin Warning Echoes Liquid Supplement Draft Guidance" - Pink Sheet, 8 March, 2010.).

The second product Durbin referenced, 5-Hour Energy Original, also is labeled as a supplement. It is sold in a 1.93-fluid ounce container and is labeled as a "shot" instead of the conventional food term "drink." Packaging also warns users about the side effects of caffeine and a potential "niacin flush" or hot feeling and skin redness that lasts a few minutes.

Bill Likely Will Not Go Anywhere Fast

Lawmakers’ discussion of the bill likely would not happen until fall at the earliest, Mister predicts.

Like Mister, Israelsen points out Congress has a full plate to contend with, including addressing the debt ceiling, and it will be out of session for several weeks this summer.

Even if the bill does not move, industry is not necessarily safe from the potential changes. Israelsen notes parts of the bill easily could be tucked into other bills as amendments.

By Elizabeth Crawford

Durbin Bill Would Narrow Definition Of Dietary Supplement

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