A NEW DAY FOR VITAMINS

WENDY TOTH

Although it had been a long time coming, the U.S. Food and Drug Administration's Good Manufacturing Practices for the vitamin and supplement industry were made final in June.

The regulations are likely to enhance the popularity of the category and make buying easier for retail.

“We don't focus a lot on nutritional supplements that help people build muscle or even to gain or lose weight, simply because of negative hype in the media. They weren't as strictly regulated in the past,” said Preston Phillips, nonfood manager, Day's Market Place, Heber City, Utah.

The rule starts going into effect this month, following several months where the safety of consumable products has been in the media spotlight. For example, recent high-profile recalls in related markets include: Menu Food's withdrawal in March of its wet pet food due to pet kidney failure; Gold City Enterprise's recall of all its toothpaste made in China due to the presence of the poisonous chemical diethylene glycol, in June; Robert's American Gourmet's withdraw of Veggie Booty flavor of snack food due to possible contamination with Salmonella wandsworth bacteria, also in June; and in July, the recall of Castleberry's Hot Dog Chili Sauce due to botulism contamination.

“I've always stayed with national manufacturers,” said Sue Vodika, HBC buyer, category manager, Bashas', Chandler, Ariz. “I don't go out on a huge limb when it comes to supplements. We stay with leading brands and are very careful about who we work with because you have to look into what you're buying.”

At Wild Oats Markets, Boulder, Colo., every vendor the retailer partners with is required to provide extensive quality assurance documentation that covers things like ingredient purity and labeling, said Christopher Depetris, director of holistic health.

“Our standards are very high. But this new initiative will raise the confidence of consumers not yet buying supplements,” he said. Besides selling its private-label vitamin line in its own stores, Wild Oats also offers them through supermarket chains like Stop & Shop Supermarket Co., Quincy, Mass.

While consumers and retailers alike are craving safety, the timing of the Good Manufacturing Practices was not intentional, industry sources said.

“It is fortuitous that the timing has come out in a year we are wrestling with food safety, but it isn't connected,” said Steve Mister, president and chief executive officer of the Council for Responsible Nutrition, Washington.

The law that regulates vitamins and dietary supplements, the Dietary Supplement Health and Education Act, was passed in 1994. It defined dietary supplements and gave manufacturers the ability to promote and sell supplements under the same types of regulations as packaged foods rather than as drugs, Mister said.

The law did, however, give the FDA authorization to pass the Good Manufacturing Practices at that time, but they weren't finalized until now.

In addition, with the original law, the FDA could take action only after a dietary supplement had been proved harmful. The purity and quality were also unregulated.

Despite the lack of strict regulation, most national brands adhered to manufacturing standards put in place by the United States Pharmacopeia (USP), Rockville, Md., a nonprofit standard-setting organization, or if the manufacturers also produce drugs, they would treat supplements as if they were under drug regulations, industry sources said.

SELF-REGULATION

“Most of the significant suppliers of store-brand supplements, such as the Top Care brand and the Full Circle line of natural and organic items, have operated with GMPs for many years, even before they were established as a final rule,” said Tony Harrington, director, program management, Topco Associates, Skokie, Ill. Top Care and Full Circle are lines distributed by Topco, which is a privately held cooperative owned by supermarket retailers, wholesalers and food-service companies.

USP has been running a verification program that involves good manufacturing practices for auditing and quality control for five years, said Srini Srinivasan, vice president for verification programs at USP. “Manufacturers are participating all over the world.”

The GMPs will empower the FDA to enforce drug-quality manufacturing standards that will “rid the industry of noncompliant manufacturers and those that distribute low-quality products,” said Paul Bolar, vice president of regulatory affairs for Nature Made-brand supplement manufacturer Pharmavite, Northridge, Calif.

The company is now in “substantial compliance with the new regulations,” as it was adhering to USP regulations as well as a set of internal standards previously, he noted. “As such, we do not foresee any negative impact to our business as we continue to quickly implement the balance of requirements by the June 2008 deadline.”

Starting in August, suppliers with over 500 employees have until June 2008 to comply, companies with fewer than 500 employees have until June 2009 and companies with fewer than 20 employees have until June 2010.

In Topco's case, “because the two Topco brands have been operating at these standards for a long time, consumers should not face any delivery disruption,” Harrington said.

For a number of members of the Council for Responsible Nutrition, it will only formalize their procedures, Mister said. “The new rule does rely very much on documentation and record-keeping, so it will require some manufacturers to add that step to the cleaning and testing they are doing,” he said.

For retailers, determining which suppliers to buy from will become a simpler task with the GMPs in place, Mister said. “As a retailer, you need to ask your suppliers, ‘Are you complying with the GMPs?’ and if you are met with anything but a complete explanation and documented steps, you might want to look into another supplier.”

Although the new practices ensure that manufacturers evaluate the identity, purity, strength and composition of their dietary supplements, they are not required, as drug makers are, to prove their products' effectiveness or safety. Still, the regulations will help ensure that the supplements truly contain what is stated on the label, in the correct concentration, and this is something consumers will appreciate, sources said.

“Consumers want more product information including disclosure of all ingredients and country of origin,” said Jeff Seacrist, spokesman for health information retail kiosk provider Healthnotes, Portland, Ore. “If they were previously concerned that dietary supplements were not high quality, the new GMPs should increase their level of confidence and spur more interest in learning about all aspects of nutrition.”

Wild Oats has a Healthnotes kiosk in every one of its stores, Depetris said. In addition, the store associates are educated on every new product to hit the shelves, he said.

Health Support

The most popular products in the vitamin and supplement category are those that promise consumers a specific health benefit, retailers and suppliers told SN.

“The number of vitamin customers is growing every day due to doctors recommending different formulations for different ailments,” said Sue Vodika, HBC buyer/category manager, Bashas', Chandler, Ariz.

Glucosamine and chondritin for joint support, as well as heart health products including fish oil, CoQ10 and flaxseed oil have become major items, said Paul Bolar, vice president of regulatory affairs for Nature Made-brand supplier Pharmavite, Northridge, Calif. “Popular products include those with strong scientific support and solution-based products,” he said.

A newcomer that is driving category growth is probiotics for digestive health, Bolar added.

“Probiotics are hot, hot, hot,” said Jeff Seacrist, spokesman for Healthnotes, Portland, Ore., a provider of health information kiosks at retail. “They are a big category not only as supplements but also as cultured dairy products like kefir and yogurt.”

“Probiotics is a sophisticated product we see growing in leaps and bounds,” added Christopher Depetris, director of holistic health, Wild Oats Markets, Boulder, Colo. “From children to the elderly, American consumers are using these formulations, which are available in up to 12 strains.”

The bacteria found in probiotics replenish the “good bacteria” that are lost due to refined sugars and flour, trans fats and stress, and increase the absorption rate of nutrients, Depetris explained.

Fish oil is growing at a 40% rate nationally among consumers, he said. The supplement has been accepted by the mainstream medical community for improved cholesterol levels and as an aid to cognitive brain function, he said.

At Bashas', the hot new product is cinnamon, Vodika said. “It's brand new and it promotes metabolism. Everyone is just going crazy over it.”
— W.T.