FDA issues guidelines on natural rubber latex

By Miles Moore
RUBBER & PLASTICS NEWS

Published: March 13, 2013 12:44 pm ET
Updated: March 13, 2013 12:47 pm ET

Related to this story

Topics Medical, Materials, Materials Suppliers, Government & Legislation

WASHINGTON — The Food and Drug Administration has issued a draft guidance document for the medical product industry on how to label medical products that do not contain natural rubber latex.

The purpose of the document, appearing March 11 Federal Register, is to make recommendations on appropriate language to convey to latex-sensitive persons that natural rubber latex was not used to manufacture a product or product container, according to FDA.

"FDA is concerned that statements submitted for inclusion in medical product labeling such as 'latex-free,' 'does not contain natural rubber latex,' or 'does not contain latex' are not accurate because it is not possible to reliably assure that there is an absence of the allergens associated with hypersensitivity reactions to natural rubber latex," the agency said in the Federal Register notice.

According to the draft document, it applies to all FDA-regulated medical products for which NR latex was not used in its manufacture or packaging.

Currently, there are no regulations requiring manufacturers to state the absence of NR latex in rubber products or packaging, though some companies include "latex-free" on their labels, FDA said. However, these labels are not necessarily scientifically accurate and can be misleading, it said.

There are various tests from ASTM International that measure various compounds related to natural rubber latex allergies, according to the draft document. But FDA is not aware of any existing tests or combination of tests that can categorically demonstrate the absence of allergenic proteins, it said.

The document recommends that when the phrase, "Not made with natural rubber latex" is used as a label, it must apply to both the product and its packaging. When such a label is appropriate only for certain components of a product, such as a vial stopper, the label must name the specific component—i.e. "The vial stopper is not made with natural rubber latex."

Manufacturers that use statements such as "latex-free" should update their labeling to use the new phrase, FDA said.

Interested parties have until June 10 to submit written or electronic comments on the draft document.


Comments

FDA issues guidelines on natural rubber latex

By Miles Moore
RUBBER & PLASTICS NEWS

Published: March 13, 2013 12:44 pm ET
Updated: March 13, 2013 12:47 pm ET

Post Your Comments


Back to story


More stories

Image

DuPont investing $100 million for more ethylene copolymer capacity

September 16, 2014 1:51 pm ET

Increased packaging demand is leading materials giant DuPont Co. to spend more than $100 million to increase capacity for ethylene copolymers at its...    More

Image

Latvian plastics recycler Nordic Plast boosts capacity

September 16, 2014 10:15 am ET

Latvian plastics waste recycler Nordic Plast Ltd. has invested more than 2.5 million euros ($3.2 million) to expand capacity and modernize production ...    More

Image

Sabic, Chinese Academy of Sciences sign five-year development agreement

September 15, 2014 11:54 am ET

Ties between one of the world's biggest oil producers and one of its biggest consumers grew tighter Sept. 12 with the announcement of a five-year...    More

Image

BASF analyzes products based on sustainability potential

September 15, 2014 11:48 am ET

Chemicals giant BASF SE has created a new process for managing its product portfolio based on sustainability criteria.    More

Image

China's Zhongtai Chemical calls off large-scale PVC project

September 12, 2014 2:16 pm ET

Accepting the gloomy reality of the PVC market, Xinjiang Zhongtai Chemical Co. Ltd. has officially canceled a 800,000-ton PVC resin project and instea...    More

Market Reports

Shale Gas Market - Analysis of North American Region

This report highlights the impact of shale-based natural gas on the North American plastics market and features an in-depth analysis of production trends in the United States during 2013 and a forecast for 2014 and beyond.

Learn more

Thermoformed Packaging 2014 Market Review & Outlook North America

This in-depth report analyzes economic and market trends, legislative/regulatory activity impacting supply and demand, business opportunities and threats, materials pricing, manufacturing technology, as well as growth strategies being implemented by thermoformed packaging companies.

Learn more

Pipe, Profile & Tubing Extrusion in North America 2014

U.S. demand for extruded plastics is expected to grow by 3 percent in 2014, with PVC remaining the largest segment.

Plastic pipe will post the strongest gains through 2018, continuing to take market share from competing materials in a range of markets.

Our latest market report provides in-depth analysis of current trends and their financial impact on the pipe, profile and tubing extrusion industry in North America.

Learn more

Upcoming Plastics News Events

January 14, 2015 - January 14, 2015Plastics in Automotive

February 4, 2015 - February 6, 2015Plastics News Executive Forum 2015

More Events