Tag Archives: FDA

FDA Warns Companies Illegally Marketing Dietary Supplements as Sunscreen

On May 22, 2018, FDA sent warning letters to companies illegally marketing dietary supplements that make unproven drug claims about sun protection without meeting FDA’s standards for safety and effectiveness. FDA said the companies are “putting people’s health at risk by giving consumers a false sense of security that a dietary supplement could prevent sunburn, … Continue Reading

Non-Profits Sue FDA to Prohibit Use of Seven Flavors

Eight non-profit organizations (Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Center for Science in the Public Interest, Environmental Defense Fund, Environmental Working Group, Natural Resources Defense Council, and WE ACT for Environmental Justice) are suing FDA to seek a prohibition on the use of various flavors in food.  The lawsuit … Continue Reading

WHO Offers Plan to Eliminate Industrially-Produced Trans Fatty Acids

One week after suggesting that adults and children reduce their intake of trans fatty acids to less than 1% of total energy intake (see our May 8, 2018 blog for details), the World Health Organization (WHO) released a plan aimed at eliminating industrially-produced trans fatty acids from the global food supply. The plan, REPLACE, is … Continue Reading

FDA Releases Intentional Adulteration Training Course

In partnership with the Food Safety Preventive Controls Alliance (FSPCA), FDA has developed a free 30-minute “Food Defense Awareness for the Intentional Adulteration (IA) Rule” online training course to assist industry in complying with Food Safety Modernization Act (FSMA) requirements under the Final Rules for Mitigation Strategies to Protect Food Against Intentional Adulteration. The training … Continue Reading

FDA Confirms Extension of Compliance Dates for Nutrition Labeling and Serving Size Rules; USDA Proposes National Bioengineered (BE) Food Disclosure Rules

FDA Confirms Extension of Compliance Dates for Nutrition Labeling and Serving Size Rules In the Federal Register for May 4, 2018, FDA issued a final rule that confirms the extension of the compliance dates for two labeling rules from July 26, 2018 to January 1, 2020 for manufacturers with $10 million or more in annual … Continue Reading

FDA and FTC Take Enforcement Action on E-Liquids That Resemble Foods

FDA has joined the Federal Trade Commission (FTC) in issuing warning letters to 13 companies that market nicotine-containing e-liquids in packaging that has the appearance of being foods that appeal to children, such as juice boxes, candies, and cookies. FDA and FTC took action based on the risk that consumers, especially children, may confuse the … Continue Reading

GAO Releases Report Recommending Additional FDA Action to Address Arsenic in Rice

In response to the U.S. Food and Drug Administration’s (FDA’s) 2016 Arsenic in Rice and Rice Products Risk Assessment Report, the Government Accountability Office (GAO) released a report on April 16, 2018 acknowledging the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) efforts to develop methods to detect arsenic in rice … Continue Reading

Food Policy Summary

In the last week there have been a number of interesting developments in food policy.  Each is in early development, but worthy of a brief note. President Trump, in a meeting regarding Chinese tariffs with Republican lawmakers from agricultural states, indicated a willingness to reconsider participation in the Trans-Pacific Partnership (TPP), perhaps as a means … Continue Reading

FDA Issues First Ever Mandatory Recall Order for Kratom Products

On April 2, 2018, FDA issued a mandatory recall order for all products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC, after several tested positive for salmonella. FDA issued the recall after the company failed to cooperate with FDA’s request to conduct a voluntary recall. This is FDA’s first ever mandatory … Continue Reading

FDA Commissioner Scott Gottlieb Comments on Intentional Adulteration

In the March 28, 2018 FDA Voice blog  Dr. Gottlieb provided background and insight on the Intentional Adulteration rule. The FDA Food Safety Modernization Act (FSMA) charges FDA with addressing the burden of foodborne illness by requiring that producers, importers and distributors of food take systematic steps to prevent contamination. Congress passed FSMA with a … Continue Reading

FDA Provides Remarks on their Role in Supporting Innovation in Food Technology

On March 22, 2018, Susan Mayne, Ph.D., Director of FDA’s Center for Food Safety and Applied Nutrition, addressed the audience at the Future Food-Tech Summit about FDA’s role in supporting innovation in food technology. Dr. Mayne divided her talk into four key questions: (1) How can food-tech innovators get the support and information they need … Continue Reading

Arkansas Passes Resolution Calling for Standard for Rice

Over the last year, dairy industry groups have appealed to FDA and Congress to enforce the standard of identity for milk with regard to plant-based beverages labeled as “milk,” for example “soy milk”.  The dairy industry argues that milk is defined as “the lacteal secretion, practically free from colostrum, obtained by the complete milking of … Continue Reading

FDA Guidance States Live Animals Processed Under USDA Regulations Do Not Need to Comply with FSVP Regulations

On March 21, 2018, the U.S. Food and Drug Administration (FDA) published guidance that live animals processed under Department of Agriculture (USDA) regulations do not need to comply with Foreign Supplier Verification Program (FSVP) requirements. In general, live animals imported for use as food are regulated by FDA. However, they are required to be slaughtered … Continue Reading

FDA Issues Draft Guidance on “Small Business” under FSMA Preventive Controls Regulations

As previously reported on this blog, FDA published final rules to implement the Hazard Analysis and Risk-based Preventive Control (HARPC) provisions for human and animal food under the FDA Food Safety Modernization Act (FSMA) on September 17, 2015. Small businesses may be eligible for certain exemptions and have later compliance dates than larger businesses covered … Continue Reading

FDA Announces Proposed EU Shellfish Equivalence Determination

The United States and the European Union (EU) have not traded live shellfish for nearly eight years. Since 2010, U.S. shellfish imports have not been allowed to enter the EU, and the U.S. Food and Drug Administration (FDA) has not permitted the import of live, fresh or fresh-frozen molluscan shellfish from the EU since the … Continue Reading

GAO Report: FDA Can Do More to Achieve Food Safety & Nutrition Goals

The Food Safety Modernization Act (FSMA), enacted in January 2011, shifted the FDA’s focus from responding to illnesses to preventing food contamination.  A new report by the U.S. Government Accountability Office, released on March 5, 2018, examines FDA’s actions on food safety since FSMA became effective. The GAO report, titled “FDA Can Build on Existing Efforts … Continue Reading

NTP Releases Draft Report on Bisphenol A for Public Comment

Bisphenol A (BPA) has been the subject of global controversy in recent years, with some jurisdictions restricting its use in children’s products and baby bottles due to concerns about potential exposure risks. FDA’s longstanding position on BPA is that BPA is safe at the current levels occurring in foods. On February 23, 2018, the National … Continue Reading

FDA Updates Spice Risk Profile

As previously reported on this blog, the U.S. Food and Drug Administration (FDA) released a draft risk profile on the public health risks associated with spices in October 2013. The risk profile identifies the presence of pathogens, such as Salmonella, and filth in spices; describes current efforts to reduce the public health risk posed by … Continue Reading

New DOJ Policy Says Government Lawyers Cannot Base Enforcement Actions on Guidance Documents

As our readership is well aware, the U.S. Food and Drug Administration (FDA) frequently issues guidance documents for all areas under its regulatory purview, including foods. These guidance documents seek to clarify and supplement existing regulations. On November 16, 2017, Attorney General Jeff Sessions ostensibly expressed a distaste for binding private parties to provisions in … Continue Reading

House Passes Bill to Ease Menu Labeling Rules

Over the past several years, FDA has been in the process of implementing menu labeling provisions added to the Federal Food, Drug, and Cosmetic Act by the Affordable Care Act. Under the new requirements, restaurants or similar retail food establishments (in chains of 20 or more locations doing business under the same name and selling substantially similar … Continue Reading

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