CRN praises FDA on revised nutrition labels
WASHINGTON — The Council for Responsible Nutrition on Friday welcomed news of the U.S. Food and Drug Administration’s proposed rule, “Food Labeling: Revision of the Nutrition and Supplement Facts Labels.”
In particular, CRN praised the agency for re-enforcing the continued use of the Recommended Dietary Allowance as the basis for determining the Daily Value for nutrients. “CRN applauds the FDA for keeping the RDA as its standard for DVs on food labels. At a time when we know of significant nutrient shortfalls in the typical American diet, it would have been a mistake to water down nutritional requirements, so that at most only half the population would be covered,” said Andrea Wong, VP scientific and regulatory affairs at CRN.
The RDA is the daily dietary intake level of a nutrient considered sufficient by the Food and Nutrition Board to meet the requirements of 97.5% of healthy individuals in each life-stage and sex group. It is calculated based on the Estimated Average Requirements, and is usually approximately 20% higher than the EAR. The EAR is expected to satisfy the needs of only 50% of the people in that age group based on a review of the scientific literature.
Despite recent concerns raised in the press by some that Americans are in danger of “overnutrifying,” the agency advised that’s not the case. FDA did a thorough review of available data and concluded that “…total nutrient intakes (from both conventional foods and dietary supplements) … do not exceed the [Tolerable Upper Levels] for most vitamins and minerals.”
"The data show that consumers are not even meeting the EAR for a number of nutrients," Wong said. "We still do urge people, however, to be aware of their total nutrient intake from foods, fortified foods and supplements. But FDA’s analysis should help put to rest those critics using overnutrification as a way to dismiss supplementation.”
In addition, CRN commended the FDA for calling out potassium and vitamin D as "nutrients of public health significance" because, according to the agency, some segments of the U.S. population are not consuming adequate amounts, putting them at higher risk for chronic disease.
Wong noted that FDA also plans to revise specific DVs, like those for calcium and vitamin D, to reflect the updated science. “This is the appropriate thing to do,” Wong said. “CRN commends the FDA on its science-based proposal to update food-labeling requirements. We believe consumers will be well-served by the changes that will affect the dietary supplement industry.”
CHPA supports keeping OTC bronchodilators in the OTC Monograph
WASHINGTON — The Consumer Healthcare Products Association earlier this week voiced support for keeping over-the-counter bronchodilators in the OTC Monograph during a recent meeting of the Food and Drug Administration’s Nonprescription Drugs Advisory Committee.
During the meeting, the committee discussed whether bronchodilators administered by hand-held rubber bulb nebulizers for the temporary relief of mild symptoms of intermittent asthma (shortness of breath, tightness of chest and wheezing) should be removed from the monograph. Specific drugs discussed included epinephrine, epinephrine bitartrate and racepinephrine hydrochloride.
CHPA VP regulatory and scientific affairs Barbara Kochanowski spoke on behalf of CHPA, stating that there is no obvious reason to abandon the OTC Monograph as a regulatory path to market. She noted that the FDA has the ability to amend the monograph to ensure proper performance specifications, such as dosing.
Kochanowski also highlighted that more than 25 million Americans suffer from asthma, and under-use of asthma medicines, particularly among minorities, is an acknowledged challenge.
Perrigo acquires portfolio of Australian OTC products for $51 million
DUBLIN — Perrigo on Friday announced that it has acquired a basket of value-brand OTC products sold in Australia and New Zealand from Aspen Global for $51 million in cash.
The products are primarily sold through the mass retail channel and include the Herron range of analgesics, vitamins and supplements. This basket of products is expected to generate at least $20 million in annual revenue.
"The acquisition of OTC products in Australia enhances our position by broadening our product offering and increasing our relevance with the mass retail customers," stated Joseph Papa, Perrigo chairman, president and CEO. "This deal furthers our strategy to expand our Consumer Healthcare portfolio internationally, while making quality products more affordable for consumers and customers around the world."