Global Life Sciences Update
As the Obama administration draws to a close, the Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN) continues, at a breakneck pace, to release multiple final or interim final rules and guidance documents pertaining to food safety, nutrition labeling and cosmetic safety. CFSAN has also begun posting adverse event reports for foods, including dietary supplements, and cosmetics, and has extended its comment period for "healthy" claims in food labeling. Whether this spurt of activity is an effort to finalize agenda items prior to the start of the next administration, or merely a prolific period in a long-term strategy, industry has much work to do to stay abreast of CFSAN's actions.
The following is a high-level overview of CFSAN's latest noteworthy activities.
In December, CFSAN published a number of documents related to its ongoing FDA Food Safety Modernization Act (FSMA) implementation process. On December 14, 2016, CFSAN published a final rule establishing user fees for its voluntary third-party certification program for food safety audits of foreign food facilities. On December 6, 2016, CFSAN issued a final guidance setting forth model standards to be used by recognized accreditation bodies to qualify third-party certification bodies. Both documents are important steps in FDA's rollout of the third-party certification program. In addition, on December 21, 2016, CFSAN published an updated training strategy for FSMA, which includes grants to facilitate training and encompasses public-private alliances that provide education on FSMA requirements. In late December, FDA also issued a revised draft Q&A guidance regarding food facility registration. CFSAN describes its FSMA strategy as "evolving" and we can expect additional updates as remaining FSMA rules are fully implemented.
Adverse Event Report Data for Foods and Cosmetics
In early December 2016, CFSAN announced (here, here and here) that it will begin posting on its website, on a quarterly basis, adverse event data for food (including dietary supplements, food additives and color additives) and cosmetics that CFSAN has received through its CFSAN Adverse Event Reporting System (CAERS). CFSAN receives adverse event reports through CAERS from consumers, health care providers and manufacturers. Previously, CAERS data was typically only made publicly available through a Freedom of Information Act (FOIA) request.
CFSAN intends these posts to yield more thorough adverse event reporting that in turn will enable CFSAN to identify potential product safety issues more quickly. However, the utility and effect of the posts remains to be seen, particularly for those industries where reporting is not mandatory. And there is no doubt that product liability law firms will be watching these voluntary and mandatory report disclosures carefully, despite the fact that the reports are not evidence of causation.
Nutrition Facts and Serving Sizes
On January 4, 2016, CFSAN released two draft guidance documents regarding FDA's final rules on Nutrition Facts labeling and Serving Sizes. Of particular interest is FDA’s focus on the "added sugar" content, new examples of food products that belong in each of the product categories of Reference Amounts Customarily Consumed per Eating Occasion and compliance dates to meet the deadlines in the Nutrition Facts final rule (81 Fed. Reg. 33742 (May 27, 2016)). The comment period for both draft guidances closes on March 6, 2017.
Health Claims for Raw Fruits and Vegetables
On December 19, 2016, CFSAN published an interim final rule (IFR) to expand the use of health claims on the relationship between saturated fat and cholesterol and risk of coronary heart disease (CHD) (codified at 21 C.F.R. § 101.75), by permitting a broader range of raw fruits and vegetables to qualify for the CHD health claim. In order to make a health claim, a food must typically contain one or more of vitamin A, vitamin C, iron, calcium, protein or fiber at or above 10 percent of the Reference Daily Intake or Daily Reference Value. Foods bearing CHD health claims must also meet the definition of a "low fat" food, among other requirements, unless the food qualifies for an exception. Previously, raw fruits and vegetables that did not meet these requirements — such as grapes, plums, beets, cucumbers, and avocados — had been ineligible to bear the CHD health claim. Referring to this outcome as an "unintended consequence," CFSAN clarifies in the IFR that low saturated fat and low cholesterol raw fruits and vegetables will now be eligible for the CHD health claim. CFSAN, however, did not amend the health claim requirements for frozen or canned vegetables, but invites comment on the issue.
Actions Relating to "Dietary Fiber" in Nutrition Labeling
On November 23, 2016, CFSAN published a request for scientific data, information and comments to aid it in determining whether certain fibers should be added to the "dietary fiber" definition that was published as part of the May 2016 Nutrition Facts final rule. At the same time, CFSAN published a draft guidance addressing how it reviews scientific evidence to determine whether other fibers beyond those identified in the rule should be added to the regulations. And just last week, FDA announced that it will provide additional time to comment on both the request and the guidance.
Genetically Engineered Pink Pineapple
On December 14, 2016, CFSAN announced (here and here) that it had completed its evaluation of a variety of pineapple genetically engineered to have pink flesh, concluding that there are no unresolved safety or regulatory questions about the product. In addition, CFSAN noted that the developer of the pineapple will identify the food as "extra sweet pink flesh pineapple" to distinguish the pink flesh pineapple from other varieties. Critically, CFSAN did not address whether the pineapple will have to bear labeling indicating that it was developed through genetic engineering, likely because federal requirements for labeling genetically engineered foods pursuant to the National Bioengineered Food Disclosure Standard have not been implemented.
Compliance Dates: Menu Labeling and Redefining "Healthy"
Before the start of 2017, CFSAN extended the formal compliance date for its final rule requiring disclosure of nutrition information for standard menu items in chain restaurants and retail food establishments to May 5, 2017. Given that the Menu Labeling Rule was introduced pursuant to the Patient Protection and Affordable Care Act, should that law be repealed, it appears that the Menu Labeling Rule could also be rolled back. CFSAN also extended the comment period on the use of the term "healthy" in the labeling of food products to April 26, 2017, leaving a major component of re-definition efforts squarely in the hands of the new administration.
Limits on the Amount of Lead in Cosmetics
On December 21, 2016, CFSAN issued a draft guidance regarding recommended maximum levels for lead in cosmetic lip products and externally applied cosmetics. CFSAN's recommended maximum level for lead as an impurity in U.S.-marketed cosmetic lip products and externally applied cosmetics is 10 parts per million (ppm). CFSAN also published a supporting document that presents the details of the scientific and legal background for the limit. This recommendation should set a clearer safety standard for industry, as well as deter state regulators from imposing their own.