FDA issues new dietary ingredient guidance
WASHINGTON — The Food and Drug Administration on Tuesday published long-awaited guidance on new dietary ingredients in the Federal Register.
Once enacted, the guidance will establish an additional pillar of credibility to the dietary supplement industry, adding to the veracity building across the industry with the implementation of a codified, supplement-specific good manufacturing practices; the adoption of the mandatory reporting of serious adverse event reports; industry efforts to educate lawmakers and healthcare professionals around the benefits of supplementation; and an industry-sponsored initiative with the National Advertising Division of the Better Business Bureau to help the industry self-regulate inaccurate advertising claims.
Specifically, the guidance establishes a protocol around when a supplement manufacturer must file a premarket safety notification of a dietary supplement containing a new dietary ingredient. The guidance addresses in question-and-answer format what qualifies as an NDI, when an NDI notification is necessary, the procedures for submitting an NDI notification, the types of data and information that the FDA recommends manufacturers and distributors consider when they evaluate the safety of a dietary supplement containing an NDI, and what should be included in an NDI notification. In addition, the guidance contains questions and answers about parts of the dietary supplement definition that can affect whether a particular substance may be marketed as a dietary ingredient in a dietary supplement.
“The dietary supplement industry has eagerly awaited this guidance in the hope that it will provide clarity and an appropriate framework for introducing new ingredients and products into the supplement marketplace,” Council for Responsible Nutrition president and CEO Steve Mister said. “This draft guidance … represent[s] an important step for the dietary supplement industry — and for the agency — as it demonstrates further implementation of the requirements of the Dietary Supplement Health and Education Act and will give companies clearer understanding of [the] FDA’s expectations under the law.”
To help explain the nuances of the new guidance for the industry, the Natural Products Association will host a webinar conference on July 11. Speakers will include Daniel Fabricant, director of the Division of Dietary Supplement Programs at the FDA’s Center for Food Safety and Applied Nutrition; Scott Bass, head of the Global Life Sciences Team at Sidley Austin; Cara Welch, Natural Products Association VP scientific and regulatory affairs; and John Gay, Natural Products Association executive director and CEO. To join the call register here.
Review the draft guidance here.
Vitamin D explodes with product growth
The vitamin D category continues to grow. Category leader Nature Made from Pharmavite is on the cusp of launching a host of new products, including a Super D-Complex with magnesium, vitamin D chewable tablets and vitamin D with vitamin C and zinc.
“I think this is category growth that has been driven by the science,” said Doug Jones, Pharmavite’s corporate communications and public relations manager. “When you get a lot of the medical establishment behind it, you see long-term sustained growth of a category. And vitamin D has received lots of press. There’s widespread recognition that there’s a deficiency problem.”
John Hathcock, SVP scientific and international affairs for the Council for Responsible Nutrition, said that the information about vitamin D is permeating the public’s awareness because it’s so all-encompassing. “For well over 50 years and perhaps closer to 75, we’ve known that vitamin D aids in the absorption of calcium and thus [helps to] build healthy bones,” Hathcock said. “But it’s also been found to help reduce the risk of cancer, hypertension and cardiovascular disease, diabetes and other metabolic syndrome issues, [and] falls related to neuromuscular activity, [as well as] immune function and all the things that result from that.”
The numbers back up the science. Sales of vitamin D were up 49% for the 52 weeks ended April 16, down slightly from last December when sales were up 73%, according to Nielsen.
Despite Pharmavite having a plethora of vitamin D products, its best-seller remains its 1,000 IU product. Also, last year the company released a product with 5,000 IU, and two years ago it launched a 400-IU chewable vitamin D product for children.
Hathcock said he expected to see more vitamin D supplements on the market — from multivitamins with vitamin D to vitamin D and calcium tablets. But with a marketplace as full as it is with new vitamin D products, how does Pharmavite ensure its products stand out? The company participates in the dietary supplement program from the United States Pharmacopeia, a scientific not-for-profit organization that has set pharmaceutical quality standards since 1820 and bears the USP’s stamp on many of its products, with more constantly being added.
Probiotics still have room to grow in digestives
Ten years ago the word probiotics wasn’t known, and five years ago it was a new word to most Americans. But thanks to the marketing of Activia yogurt by Dannon, which started in 2006, these microorganisms have garnered national attention. After Activia took the dairy market by storm, other foods fortified with probiotics, as well as probiotic supplements, followed suit.
Probiotics are live microorganisms said to be beneficial to gut health and digestion. And Americans are lapping up the information. Sales of probiotic vitamins three years ago were $10.1 million, but in the 52 weeks ended April 16, sales rose 24.8% to $46.9 million in the United States, according to Nielsen.
“People are becoming more and more interested in actively managing their health,” said Scott Popham, director of external relations for Procter & Gamble, whose product Align is one of the category leaders.
P&G launched Align in 2009, and the company has relied on the science behind its brand. According to Popham, “We hang our hat on the data behind our products, and we always make sure we have the highest standards of safety. And we have 10 years of research behind our product. So I think that’s really where we differentiate ourselves — through our science.”
The latest company to enter the probiotic market is Schiff Nutrition International, which recently purchased the rights to the OTC probiotic supplement brands Sustenex and Digestive Advantage from Ganeden Biotech.
Both of these products contain the proprietary GanedenBC30 (BC30, Bacillus coagulans GBI-30, 6086) probiotic technology. “Our focus is to deliver shareholder value by building premium brands and leading innovation,” said Tarang Amin, president and CEO of Schiff Nutrition. “By acquiring the rights to the leading probiotics technology, we have entered a new, rapidly expanding category that creates accretive growth opportunities.”
He added: “We believe BC30 has many inherent physical properties that make it superior to other traditional probiotic organisms. We intend to leverage this enviable technology and grow the Sustenex and Digestive Advantage lines. In addition, we plan to capitalize on Schiff’s brand-marketing know-how, provide incremental marketing investment and use our well-established customer relationships to increase distribution.”