HEALTH

CRN files amicus brief in support of the VMS status of fish oil

BY Michael Johnsen

The Council for Responsible Nutrition and the Global Organization for EPA and DHA Omega-3s on Friday joined forces against an attempt by Amarin Pharma to classify concentrated EPA omega-3 fish oil supplements as pharmaceuticals.

“From the start, CRN recognized that Amarin’s intentions were iniquitous,” Steve Mister, president and CEO, CRN, said. “They sought to create a market monopoly over a subset of omega-3 products, which would directly hinder legitimate manufacturers from selling fish oil supplements. CRN is committed to fight for its member companies in this space and ensure responsible industry can continue to do business without the burdensome restrictions Amarin seeks to impose. Further, inhibiting consumers’ ability to obtain concentrated omega-3 supplements without a prescription deprives consumers of the health benefits those supplements can provide.”

Omega-3 fatty acid supplements are consumed by 16% of U.S. adults according to a recent survey by CRN.

CRN joined GOED in submitting an amicus brief Friday to the United States Court of Appeals for the Federal Circuit, addressing an appeal made by Amarin Pharma protesting the International Trade Commission’s decision not to review reclassifying the prescription status of fish oil supplements.

Amarin last year asked the ITC to declare concentrated EPA to be a drug and to prohibit its importation for use in supplements, a move which CRN previously warned would “dramatically affect consumers’ access by making it more difficult and expensive, if not impossible, to obtain the health benefits associated with these products.”

In the brief, CRN and GOED defended ITC’s decision to dismiss Amarin’s complaint, as Amarin’s requested relief would require ITC to inject itself into the statutory and regulatory framework explicitly authorized to the Food and Drug Administration. Because Amarin “did not, and could not, allege that the concentrated fish-oil products accused were not, in fact, dietary supplements under any objective standard or ruling,” CRN noted that the complaint failed to satisfy the requirements of the statute and ITC’s rules governing complaints. “Market participants have significant reason to believe that the current practice of labeling concentrated omega-3 products as ‘dietary supplements’ is proper,” wrote CRN, maintaining that companies marketing these products are in no way violating the Food, Drug & Cosmetic Act, as Amarin claimed they were.

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GSK, RB no longer in running for Pfizer Consumer business

BY Michael Johnsen

GlaxoSmithKline on Friday confirmed it has withdrawn from the bidding war for the Pfizer Consumer Healthcare business, following a similar announcement made by RB earlier this week.

That doesn’t leave many companies large enough to swing the reported asking price of $20 billion for an OTC portfolio that includes powerhouse brands Advil and Centrum. Johnson & Johnson dropped out of the running in January.

“While we will continue to review opportunities that may accelerate our strategy, they must meet our criteria for returns and not compromise our priorities for capital allocation,” Emma Walmsley, CEO GSK, said.

RB released a similar statement earlier in the week. “Our priority remains organic growth, including the completion of the integration of Mead Johnson Nutrition and creating further value from reorganizing into two new business units – Health and Hygeine Home,” Rakesh Kapoor, RB CEO, said. “We always approach inorganic growth opportunities in a rigorous, disciplined and financially responsible manner to ensure long-term value creation for shareholders. An acquisition for the whole Pfizer consumer health business did not fit our acquisition criteria and an acquisition of part of the business was not possible.”

GlaxoSmithKline may have been souring to the possible acquisition of the Pfizer consumer business as early as February, when Walmsley reported GSK was looking at the deal, but not at the expense of the company’s focus on pharma.

 

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VMS industry rallies in support of soy protein health claim

BY Michael Johnsen

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.

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