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FDA

Caffeine on the Radar

Caffeine is on the radar at the U.S. Food and Drug Administration (FDA) as a growing number of new products with added caffeine are hitting supermarket shelves. That’s on top of a wide array of energy drinks and shots that have already expanded the availability of caffeine and changed habits of use.

As a first step to exploring the implications, the FDA asked the Institute of Medicine (IOM) of the National Academy of Sciences to hold a public workshop on the science and usage of caffeine. At the workshop last week in Washington, the presentations and discussions offered a deeper look into the issues as well as the FDA’s focus.

About 25 physicians and scientists gave detailed presentations touching upon the scope of caffeine intake, patterns and outcomes of use, physical and behavioral effects, safe exposure levels, and interactions with other compounds in energy products. Public participation was welcome, and several physicians, scientists and industry representatives offered questions and comments.

It quickly became clear that the meeting’s focus was on caffeine found in “unexpected sources,” such as the new foods to which caffeine is being added, which include jelly beans, sunflower seeds, marshmallows, pancake syrup, and even water. The variety was described by FDA Commissioner Margaret Hamburg in her introductory remarks as “mind boggling,” and she noted that energy drinks have “jolted the marketplace.” She also said that the FDA’s inquiry was not about caffeine in coffee and tea, but rather about “new foods where caffeine is added.” She also shared a particular concern for “vulnerable populations,” particularly children and adolescents.

The presenters offered detailed data and analyses of the various aspects of caffeine consumption being explored during the two-day meeting at the National Academy of Sciences headquarters near the National Mall. Among the topics covered were caffeine consumption levels and patterns, the pathways and impacts of caffeine on the cardiovascular and central nervous systems, data about emergency room visits triggered by energy product consumption by young consumers, potential interactions with other energy drink components such as taurine and carnitine, and areas where additional research could sharpen understanding.

Moving forward, the IOM will present the FDA with a transcript, or “proceedings,” ” of the meeting. The FDA had charged the IOM with conducting the workshop and delivering detailed proceedings without policy recommendations. The FDA will include the proceedings in deliberations on its caffeine initiative that could result in a new “guidance” document on caffeine. In light of evident Congressional pressure related to untoward outcomes from youth consumption of caffeine from new sources, the FDA is likely to act quickly this autumn.

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Federal Food Agency Tests Waters on FSMA Food Safety Plans

The wheels of government often grind slowly, but can still deliver a hefty pinch. After a yearlong delay, the Food and Drug Administration (FDA) has issued draft regulations that put significant new responsibilities on manufacturers for ensuring food safety.

Last week, the FDA issued a “proposed rule” to implement the Food Safety Modernization Act (FSMA) provision for “preventive controls,” essentially a series of backstops against potential contamination. Generally speaking, the 680-page document is the regulatory equivalent of an operating manual, spelling out proposed regulations implementing the statutory provision.

FSMA, which became law in January 2012, introduced a requirement that manufacturers of food for consumption in the U.S. develop a formal safety plan to prevent foodborne illness. However, just what compliance would entail is left up to the FDA to craft in accompanying regulations. The law provided for an automatic trigger of the preventive controls provision on July 3, 2012, but without the rules in place, the FDA had adopted temporary “discretionary enforcement” of the provision.

The newly issued proposed rule is now open to a 120-day public comment period. Following receipt and analysis of comments, the FDA will issue a final rule. Thereafter, the Agency says, it would make the preventive controls provision effective after one year. Small business are expected to be given additional time.

NCA will study the proposed rule carefully and consider filing formal comments if appropriate to advocate for the best interests of the U.S. coffee industry. NCA has already filed comments with the FDA on prior FSMA rulemaking proposals.

Preventive Controls
The FSMA preventive controls provision will require domestic or foreign manufacturers of food for sale in the United States to develop a formal plan to prevent foodborne illness. The provision also requires food makers to conduct analyses of reasonably foreseeable hazards, including acts of terrorism, and deploy preventive controls to minimize those risks. The proposed rule also requires food makers to put plans in place for correcting any problems that may spring up.

Preventive controls are one of many new provisions deployed by FSMA to improve U.S. food safety. FSMA itself signaled a fundamental shift in the nation’s approach to creating a safer food supply. Rather than the prior approach of remediation of problems after they arise, FSMA adopts an approach focused on prevention. The statute also emphasizes accountability for domestic and foreign food producers throughout the supply chain.

The first major revamp of federal food safety laws since the 1930s, FSMA grants new powers to the FDA and imposes added responsibilities for food safety throughout the supply chain. Passed by Congress in late 2010, the statute also calls for more frequent inspections of domestic and foreign facilities, re-registration by food companies, presumptive liability that companies that pack, receive or hold foods “knew or should have known” of problem conditions, a reduced threshold for administrative detention of food, and protections for whistleblowers.

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