Industry reaction mixed to NDI draft guidance
The Food and Drug Administration last month published long-awaited draft guidance on new dietary ingredients in the Federal Register. Once finalized, the guidance will establish an additional pillar of credibility to the dietary supplement industry and help counter criticism that the FDA does not regulate the safety of supplement products — that is, if the FDA doesn’t force supplements off the shelf that are already on the shelf today.
That has been one of the concerns raised early on — namely, that the finalized rule would force a spate of recalls. “We believe the draft guidance does not match Congress’ clear intent that products made from ingredients on the market prior to Dietary Supplement Health and Education Act [passing in 1994] should remain on the market,” stated Cara Welch, VP scientific and regulatory affairs for the Natural Products Association. “The FDA is asking for far more from the industry to prove that an ingredient was on the market before 1994 than most makers can probably produce. … These requirements will reduce ingredients meeting the established grandfathered status to a regrettably small number.”
In the guidance, the FDA estimated, all told, that 55,600 supplement products are currently on the market. According to the FDA, there is no authoritative list of dietary ingredients that were marketed in dietary supplements before Oct. 15, 1994. Manufacturers and distributors would be responsible for documenting that the supplement was marketed prior to that date.
“This draft guidance document describes the agency’s interpretation of the requirements for NDIs; it is not a new regulation and does not create new rights or responsibilities for the industry,” said Steve Mister, president and CEO of the Council for Responsible Nutrition. “Nevertheless, this draft guidance does represent an important step for the dietary supplement industry — and for the agency — as it demonstrates further implementation of the requirements of the [DSHEA] and will give companies clearer understanding of [the] FDA’s expectations under the law.”
If the final implementation of the NDI rule does not necessitate the recall of supplements currently sold in mass outlets, then the announcement adds to the credibility already being enjoyed by the industry, credibility fueled by factors like supplement-specific good manufacturing practices, mandatory serious adverse event reports, industry lobbying efforts and an industry-sponsored self-regulation initiative with the National Advertising Division of the Better Business Bureau.
CRN plans to host a webinar addressing the new guidance on Sept. 14.
Wellness drives sales in digestives, probiotics
Sales in the digestives aisle going forward look positive, especially as an aging population begins paying closer attention to healthy diets, including the right amount of dietary fiber to keep things “regular” and supplementation with probiotics for overall digestive health.
Awareness is certainly on the rise, and awareness drives sales. According to the Natural Marketing Institute’s “Health and Wellness Trends Survey,” awareness of the term “probiotics” grew from 9% in 2002 to 60% of American adults in 2009. Such food manufacturers as General Mills and Kellogg’s increasingly are touting the benefits of fiber. “We’ve done a lot of education, especially around whole grains and fiber,” Karlis Nollendorfs, General Mills’ senior customer insights manager, told executives during a seminar at the National Association of Chain Drug Stores’ Marketplace conference. “We recognize that a lot of people want to eat more [healthily].”
But the largest piece of the digestives pie is antacids, and this is another bright spot, with new players sparking increased advertising across the segment. For the 52 weeks ended June 12 across food, drug and mass (minus Walmart), sales of each of the major brands were up, with the exception of the largest brand — Procter & Gamble’s Prilosec OTC, which was only down 3.2% despite new competition. And sales of Prilosec OTC were only down 3.2%, according to SymphonyIRI Group data, despite the introduction in the past two years of generic competition and two new proton-pump inhibitor products. Even GlaxoSmithKline’s venerable Tums franchise is significantly up — 210.1% to $87.4 million.
And according to findings from a recent survey fielded by Braun Research on behalf of Takeda Pharmaceuticals, heartburn mostly remains a self-treatment condition. Of the 1,004 surveyed, 39% only “occasionally” discussed frequent heartburn symptoms with their doctors and 19% “never” initiated that conversation.
The article above is part of the DSN Category Review Series. For the complete Digestives Buy-In Report, including extensive charts, data and more analysis, click here.
ReportersNotebook — Over the Counter, 8/1/11
SUPPLIER NEWS — LELO launched a high-end line of Kegel exercisers called Laselle under the Intimina by LELO brand for women with incontinence issues. A meta-analysis of randomized controlled trials by the Cochrane Collaboration concluded that pelvic exercises should be included in first-line conservative management programs for women with urinary incontinence. The Kegel exercisers will retail for a suggested $12.95.
Audiovox Accessories introduced a one-size-fits-most personal sound amplifier called the RCA Symphonix. At a $299.99 price point, the product may be a little steep to carry in store, but may be ideal for online placement. In comparison, customized hearing aids can run in excess of $1,000 per ear and are not typically covered by health plans.
Reckitt Benckiser recently launched a liquid formulation of its popular Mucinex brand called Maximum Strength Mucinex Fast-Max Liquids. The four new formulations combine the mucus-busting power of Mucinex with maximum strength medicines for multisymptom relief. Two of the formulations contain acetaminophen, three contain dextromethorphan and three contain the antihistamine phenylephrine.