Reminder: Opportunity to comment on draft “healthy” symbols for FDA’s planned consumer research

 The U.S. Food and Drug Administration (FDA) has released draft options for a new voluntary “healthy” symbol for packaged foods to depict the nutrient content claim.

Draft “healthy” symbols for planned consumer research

As previously noted, on 7 May 2021 the FDA issued a notice that it intends to conduct preliminary consumer research on symbols that could be used voluntarily to convey that the nutrient content of a packaged food is “healthy.”[1] One of the appendices to the notice includes draft “healthy” symbols for this planned testing, which are copied below.  

In addition to the colored symbols pictured above, the FDA also plans to test black and white versions. The FDA also intends to test a “no information” condition where no explanation of the symbol is provided, as well as a Uniform Resource Locator (URL) condition, in which a URL is tested alongside the symbol, presumably to provide additional information explaining the meaning of the symbol.

These symbols would be included voluntarily on packaged foods that meet the “healthy” criteria that the FDA is in the process of updating as part of the agency’s Nutrition Innovation Strategy. Although the notice itself is a fairly standard procedural notice, it provides a good opportunity to comment on the draft symbols as well as the limited details the FDA has released regarding the planned consumer research. Comments are due Tuesday, 6 July 2021.

Next steps    

We will continue to monitor developments related to nutrient content claims, the voluntary “healthy” symbols, and the Nutrition Innovation Strategy.

References 

1    Hogan Lovells, FDA to test voluntary “healthy” symbols through consumer research (7 May 2021) available at: https://www.engage.hoganlovells.com/knowledgeservices/news/fda-to-test-voluntary-healthy-symbols-through-consumer-research.

WRITTEN BY:

Hogan Lovells

[View source.]

Anneke Baran Altieri

Veronica Colas

Martin Hahn

Joseph Levitt

USA - Amazon’s New Compliance Requirements for Dietary Supplement Listings to Ensure Greater Transparency and Quality for Consumers

 

As one of the largest channels facilitating the purchase and sale of dietary supplements, Amazon has often faced criticism for its lack of oversight and failure to take action to restrict the sale of supplements on its platform which are illegal, misbranded, adulterated, or otherwise dangerous for consumers. In response, Amazon recently updated its dietary supplement policy to impose additional obligations on dietary supplement sellers to ensure that products marketed on its platform are safe for consumers and are manufactured and labeled in compliance with Food & Drug Administration (“FDA”) regulations.

While Amazon’s existing policy requires that any dietary supplements listed on its platform conform to certain parameters (for example, no products may be listed which have been identified in an FDA Warning Letter as adulterated or misbranded), the new policy places affirmative reporting obligations on sellers. Specifically, the new policy requires that for each dietary supplement product, manufacturers must submit for Amazon’s approval: (i) either a Certificate of Analysis (COA) from an ISO/EIC 17025 accredited laboratory, a COA from an in-house laboratory that is compliant with current good manufacturing practices (“cGMPs”), or evidence of product enrollment in an Independent Quality Certification Program such as NSF Certified for Sport®, BSCG Certified Drug Free®, or the USP Dietary Supplement Verification Program; and (ii) product images which clearly show the entirety of the product label and contain the name and contact information of the brand owner or manufacturer. The COA requirement applies to finished dietary supplement products, with additional obligations for herbal supplements. For example, for herbal supplements which declare quantified plant constituents on their Supplement Facts panel, COAs must be submitted for each dietary ingredient.

The new policy also requires dietary supplement sellers to provide Amazon with a Letter of Guarantee issued on official brand letterhead providing assurances that (i) the product was manufactured under cGMPs, (ii) only lawful and safe ingredients are utilized in the product, and (iii) the concentration of active ingredients as stated on the label is safe for consumption. These new obligations apply to both new product listings as well as existing products which have already been listed for sale on Amazon, with a compliance deadline of May 31, 2021 for existing product listings. Accordingly, any sellers with existing dietary supplement product listings must submit the required documentation and obtain approval of their listings by May 31, 2021. The stated penalties for failure to provide the newly required information include removal of product listings, suspension of the seller’s ability to add new products or list products, a withholding of payments due to the seller, and/or potential additional legal action.

It is therefore especially critical that dietary supplement brands selling on Amazon are promptly taking steps to comply with the new policy and properly managing their quality obligations to ensure that their products are being manufactured in accordance with cGMPs, and are strongly advised to have detailed agreements in place with manufacturers which clearly spell out their respective quality and compliance responsibilities.

                                                     

USA - FDA Releases Plan for Reducing Infant Exposure to Heavy Metals

The U.S. Food and Drug Administration (FDA) has released “Closer to Zero,” its action plan for reducing infants’ exposure to heavy metals following a Congressional report on toxic elements in baby foods. “Although the FDA’s testing shows that children are not at an immediate health risk from exposure to toxic elements at the levels found in foods, we are starting the plan’s work immediately, with both short- and long-term goals for achieving continued improvements in reducing levels of toxic elements in these foods over time,” the agency states. Under the plan, FDA will (i) “evaluate the scientific basis for action levels,” (ii) “propose action levels,” (iii) “consult with stakeholders on proposed action levels,” and then (iv) “finalize action levels.” The agency will then “establish a timeframe for assessing industry’s progress toward meeting the action levels and recommence the cycle to determine if the scientific data support efforts to further adjust the action levels downward.”

“We recognize that Americans want zero toxic elements in the foods eaten by their babies and young children,” the FDA statement says. “In reality, because these elements occur in our air, water and soil, there are limits to how low these levels can be. The FDA’s goal, therefore, is to reduce the levels of arsenic, lead, cadmium and mercury in these foods to the greatest extent possible. We are also sensitive to the fact that requiring levels that are not currently feasible could result in significant reductions in the availability of nutritious, affordable foods that many families rely on for their children. Our plan, therefore, outlines a multi-phase, science-based, iterative approach to achieving our goal of getting levels of toxic elements in foods closer to zero over time.”

Mark Anstoetter et al. - Shook, Hardy & Bacon L.L.P.

USA: FDA Announces Investigation into Real Water

 

The U.S. Food and Drug Administration (FDA) has announced an investigation into Real Water alkaline water, which is allegedly the link between several cases of acute non-viral hepatitis. The investigation comes amid the filing of several lawsuits alleging harm to consumers of the water, including children. The agency announced that Real Water was not cooperating with the investigation because it failed to provide records or access to facilities.

“The FDA is committed to protecting the health of Americans and is especially concerned when there is a food safety issue impacting our youngest, and some of the most vulnerable in the population – infants and young children,” a press release stated. “Upon learning about reports of acute non-viral hepatitis in Nevada, impacting five young children, the FDA quickly activated a team to further investigate. We are working closely with the CDC, state and local partners to complete our investigation and monitor for any additional illnesses.”

By Mark Anstoetter et al. [Shook, Hardy & Bacon L.L.P.].

USA - FDA and FTC to Study Impact of Social Media Influencers

The widespread use of social media platforms make them ideal for companies trying to reach a large audience.  Pharmaceutical and consumer products industries frequently maintain their own social media accounts and partner with celebrities, physicians, patients, and “influencers”—i.e., individuals who have achieved online celebrity and whose posts reach a wide audience—to endorse their products through social media campaigns.  Although U.S. regulatory agencies have already been closely monitoring the development of these advertising platforms, the Food & Drug Administration (FDA) and the Federal Trade Commission (FTC) have both recently announced efforts to modernize their understanding of the impact that endorsers have on consumers, signaling the likelihood of more aggressive enforcement in the near future.

The FDA has proposed two studies geared towards evaluating the impact of different types of endorsers (celebrity, physician, patient, and influencer) and payment disclosures on consumers. The agency has invited comments on:

• whether the proposed collection of information is necessary for the proper performance of FDA’s functions, including whether the information will have practical utility;
• the accuracy of FDA’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
• ways to enhance the quality, utility, and clarity of the information to be collected; and
• ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

The comment period ends on March 30, 2020.

The FTC is currently engaging in a systematic review of its regulations and guides, and is accepting comments on its existing “Guides Concerning the Use of Endorsements and Testimonials in Advertising” (the Guides).  The Guides serve an advisory purpose, assisting businesses and others to conform their endorsement and advertising practices to the requirements of Section 5 of the FTC Act.   The topics that the FTC is seeking comments on include the following key areas:

• modifications to the Guide that are necessary in response to technological, economical, or environmental changes;
• the effectiveness and necessity of disclosing material connections;
• consumers’, with an emphasis on young consumers’, understanding of disclosures of material connections;
• the practice of offering incentives to individuals who are not endorsers in exchange for positive reviews;
• the practice of soliciting feedback and funneling satisfied customers to review sites and dissatisfied consumers to further customer service resolution centers; and
• the use of affiliate links.

Commissioner Rohit Chopra released a statement on February 12, 2020 in which he encouraged “[codifying] elements of the existing endorsement guides into formal rules so that violators can be liable for civil penalties.” Businesses interested in having their input considered by the FTC should submit their responses to the FTC’s request for comments before the comment deadline of April 21, 2020.

The actions taken by these regulatory agencies reflect a growing interest in how a company uses endorsers to market consumer products and suggests that the regulatory landscape may soon evolve. Ballard Spahr will continue to monitor this space for further developments.  In the meantime, FDA and FTC regulated companies should consider submitting comments to the appropriate regulatory authority and revisting their advertising practices with regard to endorsements.

Gregory Szewczyk

Philip Yannella

Ballard Spahr LLP

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USA: FDA Issues 2019 Voluntary Retail Food Regulatory Program Standards

• FDA issued the 2019 edition of the Voluntary National Retail Food Regulatory Program Standards (“Retail Program Standards”) on November 14.  The Retail Program Standards define the key elements of an effective retail food regulatory program for state, local, tribal, and territorial food regulatory jurisdictions. The Retail Program Standards also provide recommendations for designing and managing retail food regulatory programs and help regulatory jurisdictions facilitate more effective inspections, implement foodborne illness prevention strategies, and identify program areas in need of improvement.
• The 2019 edition incorporates changes based on recommendations discussed at the Conference for Food Protection 2018 Biennial Meeting. Such changes include updates to the standard that assists food regulatory jurisdictions in developing and implementing a program policy, as well as a new tool that helps food regulatory jurisdictions assess their food safety risk factors and interventions.
• The Retail Program Standards are designed to help food regulatory programs enhance the services they provide to the public. When applied in the intended manner, the Program Standards should:
  • Identify program areas where an agency can have the greatest impact on retail food safety
  • Promote wider application of effective risk-factor intervention strategies
  • Assist in identifying program areas most in need of additional attention
  • Provide information needed to justify maintenance or increase in program budgets
  • Lead to innovations in program implementation and administration
  • Improve industry and consumer confidence in food protection programs by enhancing uniformity within and between regulatory agencies
• According to the FDA, achieving national uniformity among regulatory programs responsible for retail food protection in the U.S. has long been a subject of debate among the industry, regulators, and consumers. As our readers may know, since 1993, the FDA has published the FDA Food Code, which is a model code that assists food control jurisdictions at all levels of government by providing them with a scientifically sound technical and legal basis for regulating retail and food service establishments. While the adoption of the FDA Food Code has been a keystone in the effort to promote greater uniformity, the Retail Program Standards address a missing link in that uniformity by establishing recognized standards for the regulatory programs that administer the Food Code.

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[USA] Are You Sure You’ve Got Milk?

Alternatives to traditional food products have increased in availability, number, variety and popularity over the last decade.  So where does this leave consumers and the regulators who are tasked with ensuring food safety?  The Ninth Circuit has held that the reasonable consumer can digest the differences between almonds and cows.

In Painter v. Blue Diamond Growers, No. 1755901, 2018 WL 6720560, at *1 (9th Cir. Dec. 20, 2018), the Ninth Circuit affirmed the District Court’s dismissal of the plaintiff’s complaint with prejudice on the grounds of preemption and failure to state a claim pursuant to Federal Rule of Civil Procedure 12(b)(6).  On behalf of a putative class, the plaintiff claimed that Blue Diamond mislabeled its almond beverages as “almond milk” and that they should be labeled “imitation milk” because they are inferior substitutes for dairy milk.

The Ninth Circuit found almond milk is not an “imitation” of dairy milk within the meaning of the applicable federal regulations, emphasizing that “it is not plausible that a reasonable consumer would assume that two distinct products have the same nutritional content.”  The Ninth Circuit agreed with the District Court that “no reasonable consumer could be misled by [Blue Diamond’s] unambiguous labeling or factually accurate nutritional statements.”

The U.S. Food and Drug Administration is evaluating whether the labeling of plant-based alternatives may lead consumers to believe these products have the same key nutritional attributes as their dairy counterparts.  In particular, FDA is looking at children’s health issues related to plant-based milk alternatives.  FDA Commissioner Scott Gottlieb, M.D., stated that FDA “intend[s] to look at whether parents may erroneously assume that plant-based beverages’ nutritional contents are similar to those of cow’s milk[.]”  On this issue, FDA is soliciting public input to answer the following questions:

1. How do you use plant-based products?
2. What is your understanding of dairy terms like milk, yogurt and cheese when they are used to label plant-based products?
3. Do you understand the nutritional characteristics of plant-based products?  Do you know how they’re different from each other?  Do you know how their nutritional qualities compare with dairy products?

FDA has extended the public comment period on this issue until January 28, 2019.

Cellular agriculture alternative

Alternatives to dairy products are not the only “imitation” foods getting attention these days.  Cellular agriculture and plant-based dairy alternatives have raised similar questions.

Cellular agriculture produces meat, poultry and seafood from animal cell cultures to replicate the characteristics of muscle harvested from food-producing animals.  This process has led regulators to question how to label such cultured food products effectively.  Some suggest the “meat” grown in a lab, rather than on a farm, should be called “cultured meat,” “cell-based meat,” “artificial meat,” or “clean meat.”  Others feel these products should not be associated with “meat” in the traditional sense whatsoever.

At a public meeting this past summer, FDA engaged in a dialogue with food industry and consumer representatives about how to embrace cell-cultured foods, while keeping consumers safe and fully informed.  It has since been announced that FDA will create a joint regulatory framework with the USDA to oversee cultured livestock and poultry products.  The joint regulatory scheme’s details are yet to be determined, but the effort may implicate future jurisdictional issues with respect to cultured meat products.

It remains to be seen if FDA’s stance on labeling plant-based dairy alternatives will affect the agency’s stance on cell-based meat labeling.  Only time will tell how well consumers understand terms such as “milk” and “meat.”  What is clear is that “imitation” and cultured food products will be a hot topic to watch in 2019, especially from a regulatory standpoint.

Jessica Brennan and Abigail Luhn

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USA: New Guidance for Nutrition Labeling

During November 2018, FDA issued two new guidance documents — one final and one draft — to support the nutrition labeling final rules issued in 2016.  Most companies must comply with the new final rules by January, 1, 2020. Companies with less than ten million dollars in annual food sales have an extra year to comply, with all inventory phased in by January 1, 2021. Despite these absolute compliance dates, many manufacturers have chosen to phase in their inventory sooner to have current and contemporary labels. The new final guidance relates to compliance dates, added sugars and declaring quantitative amounts of vitamins and minerals, replacing the draft guidance from January 2017. Even though FDA received over 1,600 comments regarding the draft guidance, its essence didn't change dramatically. The guidance includes expanded information about calculating added sugars from concentrated juices, as well as a revised table for vitamin and mineral rounding rules. The new draft guidance relates to single serving containers and dual column labeling for packages that contain at least 200% and up to and including 300% of reference amounts customarily consumed, in addition to other topics of interest to food labelers. Comments on the draft guidance are due to FDA by January 4, 2019. The guidance documents are available here:  https://www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM624571.pdf  Article publlshed by https://www.foodlabels.com/food-label-news W

Artificial trans fats are now officially banned in the U.S (June 20, 2018)

As of June 18, trans fats are banned from U.S. restaurants and grocery stores. Food manufacturers have had three years to phase out the ingredient, which the U.S. Food and Drug Administration (FDA) ruled unsafe to eat in 2015. According to the Washington Post, nutrition researchers and public health advocates long ago found artificial trans fats, a modified form of vegetable oil, raised “bad” cholesterol and contributed to heart disease.

Initially used to extend shelf life and improve the texture of processed foods in the 1950s and 60s, researchers began to link artificial trans fats to cholesterol and heart disease in the 1990s. As the scientific consensus grew, the FDA required food companies to disclose artificial trans fats on product labels in January 2006. Then, in 2015, the agency ruled that artificial trans fats are not safe in food and set a June 2018 deadline for their removal from the food system. Between 2015—when the ban was first announced—and 2018, food companies have removed 98% of trans fats from the food supply.

There is now concern over the ingredients that are being used to replace trans fats in formulations. For example, some environmental groups have raised concerns that food companies are using palm oil, which contributes to deforestation. There has also been concern that food manufacturers might boost the flavor and texture of newly reformulated products by increasing the fat content overall.