VMS industry rallies in support of soy protein health claim
The Food and Drug Administration is proposing to revoke its regulation allowing suppliers to make a health claim associating consumption of soy protein with prevention of coronary heart disease. Instead, the agency is proposing to allow manufacturers to make qualified claims supporting the consumption of soy protein, which is arguably less compelling to industry.
The claim was first authorized in 1999.
Both the Council for Responsible Nutrition and the Natural Products Association this week responded in support of the authorized health claim.
“We are concerned that FDA’s proposal to revoke the regulation authorizing the us of the claim is inconsistent with evaluations by other international regulatory bodies,” CRN submitted in a letter to the agency. CRN noted that Health Canada in 2015 concluded that the “evidence consistently supports a direction of effect toward a reduction in total and LDL cholesterol levels when soy protein is consumed.”
“The FDA has failed to offer any compelling evidence in its proposal to eliminate the soy heart health claim,” Daniel Fabricant, president and CEO of NPA, said. Fabricant pointed to the significant amount amount of evidence that supports the health claim.
According to the NPA, not only does soy protein lower LDL cholesterol directly, but also indirectly by replacing animal protein sources with plant-based soy protein sources. The combined intrinsic and extrinsic effects of soy to lower LDL cholesterol is 10.3%, NPA reported, which is on par with the heart health claim for plant sterols and stanol esters to reduce LDL cholesterol by 10%.
The FDA made its proposal to revoke the soy protein health claim in October. “While some evidence continues to suggest a relationship between soy protein and a reduced risk of heart disease – including evidence reviewed by the FDA when the claim was authorized – the totality of currently available scientific evidence calls into question the certainty of this relationship,” the agency stated in a release. “Should the FDA finalize this rule, the agency intends to allow the use of a qualified health claim as long as there is sufficient evidence to support a link between eating soy protein and a reduced risk of heart disease. A qualified health claim, which requires a lower scientific standard of evidence than an authorized health claim, would allow industry to use qualifying language that explains the limited evidence linking consumption of soy protein with heart disease risk reduction.”
The agency has promised to review comments received on this matter before issuing a final decision.
Chewpod introduces energy, sleep supplements as functional gum
Chewpod, a functional gum looking to deliver either increased energy or a good night’s sleep, will be available to U.S. consumers starting this month. A product of Los-Angeles based Khloros Innovation, a Canadian-based maker of chewable supplements, Chewpod is an efficient, easy-to-absorb product.
“We are looking forward to growing and expanding in the U.S. as we believe there is a great opportunity for functional gums and chewable tablets and their benefits especially knowing that global consumption of energy gum has grown an average of 6.6% every year for the past six years,” Joey Thiffault, president Chewpod, said. “The feedback we have received in the Canadian markets has been extraordinary. We believe that U.S. consumers will find the same satisfaction with our products.”
The Chewpod Energy On Demand functional gum is formulated with vitamins B6 and B5, caffeine, taurine and guarana seed extract. The Sleep on Demand SKU contains melatonin, vitamin B6 and natural amino acids to enhance total sleep time and quality, and help regulate the body’s natural sleep/wake cycle.
The Chewpod functional gum products are currently available for purchase on Chewpod.com and via Amazon. A single pack with four servings is $5. Bundles of four and bundles of 10 are also available for $18 and $40 respectively.
Available in the U.S. in two focus areas, the chewable supplement provides a beneficial effect on energy and ability to recover. Chewpod’s Fastactiv technology allows consumers to control their state of mind on demand, encouraging them to live every moment to the fullest regardless of the activity at hand.
Each pack of Chewpod comes with eight individually packaged, chewable, refreshing mint tablets. The Fastactiv technology delivers a pleasant energy quickly and is easily absorbed by the body.
All products are locally manufactured in North America and distributed exclusively in the United States and Canada.
CHPA conference highlights need for new avenues
The 2018 CHPA Annual Executive Conference, held last week at Turnberry Island north of Miami made news, provided the OTC industry with actionable insight, reorganized leadership, expanded its scope and honored one of its own. On the content side, the conference focused on the how to leverage disruption for innovation and growth.
There was a strong recurring theme throughout the conference; the OTC industry truly needs new growth avenues.
One of the staple industry presentations, IRI’s Changing Competitive and Retail Landscape, clearly showed slower growth and industry disrupters. The U.S. OTC industry reached $44 billion in revenues in 2017 (compared to the Rx market of $451Bn.) but recorded an anemic 5-year low 2.4% growth even with the strong flu season’s tailwinds. Even perhaps more surprising, U.S. OTC market growth outpaced Rx growth which came in at a recent low of 1.2%. Several ongoing growth trends — store-brand products, lack of major Rx-to-OTC switches and fewer innovative new products—all contributed. Meanwhile, brand owners had to continue to adjust to other unrelenting challenges, with drug chains visits dropping 6% and e-commerce’s share, now at 17% of consumer healthcare sales led by VMS and Weight Management, increasing. If the huge U.S. flu season impacting 10-12% of the country or over twice the 2016 rate hadn’t occurred, 2017 would have been a tough year for most conference attendees.
IRI did provide a roadmap for growth or at least focus areas. The overall trends point towards three core consumer groups providing growth potential: millennials, Boomers and Hispanics. And the go-to-market norms will be further disrupted by the continued growth of “click and collect” and the refinement of voice activation purchasing.
Within the CHPA vision and mission, CEO Scott Melville outlined several new CHPA initiatives and a new organizational structure. Notably, the trade group will now welcome non-Rx Medical Devices while reorganizing into three councils covering OTC Drugs, Supplements and now, Medical Devices. On the ongoing meeting front, the general Marketplace Exchange will be transitioned into two focused meetings: Marketing and Supply Chain.
Meanwhile, the industry’s long-desired Monograph Reform does seem to be gaining some traction in a difficult political environment. In a CHPA leadership discussion, Barbara Kochanowski, CHPA’s senior vice president of regulatory and scientific affairs, was quite positive about Food and Drug Administration commissioner Scott Gottlieb’s openness with the Policy Roadmap initiative providing clearer rules and a publicly available dashboard for tracking FDA progress on various issues. CHPA also is supporting a return for OTC eligibility within health savings accounts while continuing the industry’s long-standing consumer communication goals of safe usage, storage and disposal of OTCs.
CHPA also saw a changing-of-the-guard with the election of the CEO of Clarion Brands, Gary R. Downing replacing Jeffrey Needham, Perrigo executive vice president and president of U.S. consumer healthcare. Clarion is a Swander Pace Capital company and Downing brings 30+ years of domestic and international OTC experience. Lastly, the CHPA’s highest honor, the Ivan Combe Award was bestowed on John Hendrickson, the retiring CEO of Perrigo.
Ed Rowland is a Drug Store News Contributing Editor covering global issues. As the principal of Rowland Global LLC (www.rowland-global.com) he believes in the promise of global business and supports companies in their strategy, tactics and execution of international growth initiatives.