HEALTH

NPA to China: Increase transparency, U.S. imports

BY Michael Johnsen

WASHINGTON — The Natural Products Association on Wednesday outlined five key industry issues for the U.S. Department of Commerce and the Office of the United States Trade Representative for the U.S.-China Joint Commission on Commerce and Trade.

The NPA focused on removing barriers for trade to China with recommendations on increasing transparency, clarifying and reforming regulations, and enhancing export opportunities.

“Ranking fourth in sales behind the United States, Japan and Europe, China is a market of growing importance for dietary supplement makers and the natural products industry at large,” stated John Gay, NPA executive director and CEO. “NPA continues to play a constructive role with U.S. and Chinese officials to work toward the goal of increasing U.S. exports.”

NPA’s recommendations focused on five key areas:

  • Product registration: Reduce the time and cost of registering new and existing products with China’s State Food and Drug Administration;

  • Functional claims: Expand China’s list of approved functional claims and simplify the regulatory process;

  • Potency restrictions: Modify potency-level restrictions to conform to current dietary supplement research;

  • Dosage form: Clarify among regulators, custom agents and manufacturers the form in which dietary supplements may be sold in China; and

  • Gray market activity: Eliminate ambiguity and the restrictive nature of current regulations to encourage companies to follow the SFDA’s regulations.

For the complete copy of the NPA’s comments, go to NPAinfo.org/comments.

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HEALTH

Asthma relief soon to revert to Rx-only indication

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday announced that the only over-the-counter asthma inhaler sold in the United States no longer will be available as of Dec. 31 as part of an international agreement to stop the use of substances that damage the environment.

Armstrong Pharmaceuticals’ Primatene Mist (epinephrine) is approved by the FDA for the temporary relief of occasional symptoms of mild asthma. As part of the announcement, the FDA urged those who use Primatene Mist to see a healthcare professional soon to switch to another asthma medicine.

Primatene Mist inhalers are being discontinued because they use chlorofluorocarbons, or CFCs, as a propellant to move the medicine out of the inhaler so patients can breathe the medicine into their lungs.

“There are many other safe and effective medications to treat the symptoms of asthma,” stated Badrul Chowdhury, director of the FDA’s Division of Pulmonary, Allergy and Rheumatology Products. But you need to find out if you really have asthma — not just pick another over-the-counter medicine, Chowdhury added. “If you have breathing problems but have not been diagnosed by a healthcare professional, it’s important to see one. Not all breathing problems are asthma, so you need to get an accurate diagnosis and the proper medicine.”

Many manufacturers have changed their inhalers to replace CFCs with an environmentally friendly propellant called hydrofluoroalkane, or HFA. There currently is no HFA version of the Primatene Mist inhaler.

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Report: Busy Breathers backpack gains distribution in Colorado Walgreens

BY Michael Johnsen

STERLING, Colo. — The value in enabling innovation and niche marketing at the store level was evidenced in a Journal-Advocate report Tuesday around the introduction of an innovative healthcare product that was picked up across three individual Walgreens.

The full report can be found here.

Armed with a $15,000 grant from the Huggies MomInspired grant program, Michelle Staley currently is building out her business around an oxygen-tank-friendly backpack called Busy Breathers, which would appeal to two prescription-heavy demographics — preemie babies and seniors suffering from COPD.

Staley was inspired to design the backpack to accommodate her son, who was born prematurely and required oxygen over the first two years of life.

In addition to propositioning Colorado-area Walgreens, Staley also is seeking distribution through oxygen and medical supply companies, according to the report.

The bag is designed for use by adults or children and can hold three cylinders of oxygen, with an opening for the tubing through the side, a rubberized handle, an "across the chest" strap with extra padding, two-sided zippers and a mesh opening to determine the amount of oxygen left in the tank. Suggested retail price is $39.99.

The website for the product is BusyBreathersLLC.com.

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