Introduction Food Safety Modernisation Act Adverse event reports Nutrition facts and serving sizes Health claims for raw fruits and vegetables Dietary fibre Genetically engineered pink pineapple Compliance dates Lead limits
As the Obama administration drew to a close, the Food and Drug Administration's (FDA) Centre for Food Safety and Applied Nutrition (CFSAN) continued, at a breakneck pace, to release multiple final or interim final rules and guidance documents pertaining to food safety, nutrition labelling and cosmetic safety. The CFSAN also began posting adverse event reports for foods – including dietary supplements – and cosmetics, and extended its comment period for 'healthy' claims in food labelling. Whether this flurry of activity was an effort to finalise agenda items before 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 the CFSAN's actions.
This update summarises the CFSAN's latest noteworthy activities.
In December 2016 the CFSAN published a number of documents related to its ongoing FDA Food Safety Modernisation Act implementation process. On December 14 2016 the CFSAN published a final rule establishing user fees for its voluntary third-party certification programme for food safety audits of foreign food facilities. On December 6 2016 the CFSAN issued its final guidance setting forth model standards to be used by recognised accreditation bodies to qualify third-party certification bodies.
Both documents are important steps in the FDA's roll-out of the third-party certification programme. In addition, on December 21 2016 the CFSAN published an updated training strategy for the Food Safety Modernisation Act, which includes grants to facilitate training and encompasses public-private alliances that provide education on the act's requirements. In late December 2016 the FDA also issued revised draft guidance in Q&A format regarding food facility registration. The CFSAN describes its Food Safety Modernisation Act strategy as "evolving" and additional updates are expected as the remaining Food Safety Modernisation Act rules are fully implemented.
In early December 2016 the CFSAN announced that it will begin posting on its website, on a quarterly basis, adverse event data for food (including dietary supplements, food additives and colour additives) and cosmetics that it has received through the CFSAN Adverse Event Reporting System (CAERS).(1) The CFSAN receives adverse event reports through CAERS from consumers, healthcare providers and manufacturers. Previously, CAERS data was typically made publicly available only through a Freedom of Information Act request.
The CFSAN intends these posts to yield more thorough adverse event reporting that in turn will enable it to more readily identify potential product safety issues. However, the utility and effect of the posts remain to be seen, particularly for those industries where reporting is not mandatory. 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 the CFSAN released two draft guidance documents regarding the FDA's final rules on nutrition facts labelling and serving sizes, which addressed, among other things:
- the FDA's focus on 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.(2)
The comment period for both draft guidance documents closes on March 6 2017.
Health claims for raw fruits and vegetables
On December 19 2016 the CFSAN published an interim final rule to expand the use of health claims on the relationship between saturated fat and cholesterol and the risk of coronary heart disease,(3) by permitting a broader range of raw fruits and vegetables to qualify for the coronary heart disease 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 fibre at or above 10% of the reference daily intake or daily reference value. Foods bearing coronary heart disease 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, beetroots, cucumbers and avocados – were ineligible to bear the coronary heart disease health claim. Referring to this outcome as an "unintended consequence", the CFSAN clarifies in the interim final rule that low saturated fat and low cholesterol raw fruits and vegetables will now be eligible for the coronary heart disease health claim. However, the CFSAN did not amend the health claim requirements for frozen or canned vegetables, but invites comment on the issue.
On November 23 2016 CFSAN published a request for scientific data, information and comments to determine whether certain fibres should be added to the 'dietary fibre' definition published as part of the nutrition facts final rule of May 2016. At the same time, the CFSAN published draft guidance addressing how it reviews scientific evidence to determine whether other fibres beyond those identified in the rule should be added to the regulations. In January 2017 the FDA announced that it will provide additional time to comment on both the request and the draft guidance.
Genetically engineered pink pineapple
On December 14 2016 the CFSAN announced 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.(4) The 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, the CFSAN did not address whether the pineapple must bear labelling to indicate that it was developed through genetic engineering – likely because federal requirements for labelling genetically engineered foods pursuant to the National Bioengineered Food Disclosure Standard have not been implemented.
Before the start of 2017, the CFSAN extended the formal compliance date for its final rule requiring disclosure of nutritional information for standard menu items in chain restaurants and retail food establishments to May 5 2017. Given that the Menu Labelling Rule was introduced pursuant to the Patient Protection and Affordable Care Act, if that law were repealed, it appears that the Menu Labelling Rule could also be rolled back. The CFSAN also extended the comment period on the use of the term 'healthy' in the labelling of food products to April 26 2017, leaving a major component of redefinition efforts squarely in the hands of the new administration.
On December 21 2016 the CFSAN issued draft guidance regarding the recommended maximum levels for lead in cosmetic lip products and externally applied cosmetics. The CFSAN's recommended maximum level for lead as an impurity in US-marketed cosmetic lip products and externally applied cosmetics is 10 parts per million. The 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 the industry and deter state regulators from imposing their own.
For further information on this topic please contact Diane C McEnroe or Sarah M Goldstein at Sidley Austin LLP's New York office by telephone (+1 212 839 5300) or email ([email protected] or [email protected]). Alternatively, please contact Deepti A Kulkarni at Sidley Austin LLP's Washington DC office by telephone (+1 202 736 8000) or email ([email protected]). Alternatively, please contact Emily Marden at Sidley Austin LLP's Palo Alto office by telephone (+1 650 565 7000) or email ([email protected]). The Sidley Austin LLP website can be accessed at www.sidley.com.
Endnotes
(2) 81 Fed Reg 33742 (May 27 2016).
(3) Codified at 21 CFR Section 101.75.
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