FDA Finds High Levels of Heavy Metals in Kratom Products

In a press announcement released on November 27, 2018, FDA Commissioner Scott Gottlieb revealed that FDA scientists found “disturbingly” high levels of heavy metals in kratom products. Kratom, also known as Mitragyna speciosa, which is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. Kratom has opioid properties and stimulant-like effects, … Continue Reading

FDA Announces New Steps to Protect Youth From Tobacco Harms; National Youth Tobacco Survey Results Released

On November 15, FDA and the Centers for Disease Control (CDC) published the results of the National Youth Tobacco Survey (NYTS).  As summarized in their joint Statement, the “NYTS is a cross-sectional, voluntary, school-based, self-administered, pencil-and-paper survey of U.S. middle and high school students.”  Results of the survey showed a 78 percent increase from 2017 … Continue Reading

FDA Announces Meeting to Discuss Eliminating Youth E-Cigarette Use

On September 12, 2018, FDA Commissioner Dr. Scott Gottlieb announced FDA’s Youth Tobacco Prevention Plan in response to the perception that use of e-cigarettes has become an “epidemic”.  Dr. Gottlieb’s concern is based on preliminary data from the National Youth Tobacco Survey, expected out in November, which suggests that the number of high-school-age children reporting … Continue Reading

FDA Announces Increased Enforcement to Curb Youth E-Cigarette Use

In a September 12, 2018 press release, FDA announced its largest coordinated enforcement effort in agency history to address what it described as an “epidemic” of e-cigarette use in minors, based on not-yet-released survey data.  As part of its enforcement since June 2018, FDA has issued 1,300 warning letters and imposed civil penalties on brick-and-mortar … Continue Reading

FDA Announces Continued Kratom Safety Concerns and Issues Warning Letters to Kratom Marketers

In a press announcement released on September 11, 2018, FDA Commissioner Scott Gottlieb, M.D., emphasized the Agency’s continuing concerns about kratom products. Our readers may remember our previous posts about kratom, also known as Mitragyna speciosa, which is a plant that grows naturally in Thailand, Malaysia, Indonesia, and Papua New Guinea. According to FDA, there … Continue Reading

FDA Releases Q&A for Preventive Controls for Animal Foods

In light of the approaching September 17, 2018 compliance date for small animal food businesses (i.e., those with less than 500 full-time equivalent employees) to comply with Hazard Analysis and Risk-Based Preventive Controls (HARPC) rules, FDA has released a Q&A document concerning what to expect in the near term regarding FDA enforcement and inspections. The … Continue Reading

Senators Urge FDA to Get Tough on Flavored Vaping Products

Fourteen senators, including Senate Minority Whip Dick Durbin (D-IL), have sent a letter to FDA criticizing the agency for what it characterizes as lax enforcement that has allowed children to get addicted to flavored vape products in recent years.  In particular, the letter calls out flavors like gummy bear, cotton candy, peanut butter cup, and … Continue Reading

FDA to Issue a Guidance Document Limiting Use of Milk in Plant-Based Beverages

In the 2018 POLITICO Pro Summit, FDA Commissioner Scott Gottlieb signaled that FDA will begin collecting comments regarding enforcement of standard of identity for “milk”.  As noted in our June 27 blog, FDA is holding a public meeting on July 26, 2018 to discuss its Nutrition Innovation Strategy, including standards of identity.  FDA indicated in … Continue Reading

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

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

FDA Targets Highly Concentrated Caffeine in Dietary Supplements

As previously reported on this blog in 2015, FDA warned that it intended to “aggressively monitor the marketplace for pure powdered caffeine products and take action as appropriate.” The Agency made this announcement shortly after sending Warning Letters to five companies that distributed pure powdered caffeine. In the letters, FDA stated that it concluded that … Continue Reading

FDA oversees destruction and recall of kratom products

On February 21, FDA issued a press release announcing the voluntary destruction and recall of a large volume of kratom-containing dietary supplements manufactured and distributed nationwide under the brand names Botany Bay, Enhance Your Life and Divinity The manufacturer of the products, Divinity Products Distribution, has also agreed to stop selling all products containing kratom … Continue Reading

E-Commerce Enforcement

FDA takes significant action to stop illegal drug sales online. FDA has broad regulatory authority over the marketing of food, drugs, medical devices, and cosmetics in the U.S.  Although many of the Agency’s enforcement actions target physical facilities and products on shelves, FDA also has authority over e-commerce, i.e., the significant sales of FDA-regulated products … Continue Reading

Recalls Revisited

HHS OIG issues early alert criticizing FDA’s food recall procedures. Under the FDA Food Safety Modernization Act (FSMA), FDA now has mandatory recall authority over conventional foods.  However, FDA has only threatened the use of this authority twice.  In reality, firms continue to work voluntarily with FDA to recall risky foods under the Agency’s recall … Continue Reading

Supplement Stimulant Spotlight

FDA warns companies marketing dietary supplements that contain methylsynephrine. As previously covered on this blog, FDA has the authority to take enforcement action against unlawfully marketed and/or dangerous dietary ingredients in dietary supplements.  In the last year, FDA has taken action against beta-methylphenethylamine (BMPEA), 1,3-Dimethylbutylamine (DMBA), and kratom, to name a few prominent examples. FDA recently sent Warning … Continue Reading

Roos Blues

Roos Foods pleads guilty to FD&C Act violation in connection with 2014 Listeria outbreak. Thanks to the FDA Food Safety Modernization Act (FSMA), FDA now has the authority to suspend a food facility’s registration where there is a “reasonable probability” (of which the facility is or should be aware) that exposure to food will cause serious adverse … Continue Reading

Kratom Crackdown

FDA announces seizure of dietary supplements containing kratom. FDA has many tools in its arsenal to protect the public from adulterated, misbranded, and/or dangerous food and dietary supplement products; these include the Agency’s inspection power and various enforcement authorities (e.g., Warning Letters, mandatory recall orders in class I situations, administrative detention, seizure, suspension of facility … Continue Reading

Cigarette Break

FDA issues order to stop further sale and distribution of four cigarette products. As highlighted recently on this blog, FDA has the authority to regulate various tobacco products (cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco … Continue Reading

Cough Up the Caffeine

FDA issues Warning Letters to five distributors of powdered caffeine alleging safety risks inherent to product use. FDA regulates the marketing of dietary supplements.  Under Section 402(f)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), a supplement is adulterated when it “presents a significant or unreasonable risk of illness or injury under…conditions of use recommended … Continue Reading

FDA Burns Tobacco

FDA issues Warning Letters to three tobacco manufacturers regarding “additive-free” and “natural” claims. FDA has the authority to regulate various tobacco products (cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control … Continue Reading

Understanding Untitled Letters

FDA responds to Congressional inquiry regarding the Agency’s policies on Untitled Letters. As previously covered on this blog, the U.S. House Committee on Energy and Commerce requested information from FDA regarding the Agency’s policies on the issuance and publication of Untitled Letters.  Congress seemed concerned that FDA may be using Untitled Letters to advance new … Continue Reading


Congress questions FDA policy regarding the publication of Untitled Letters. FDA has the authority to issue two types of letters to regulated entities:  Warning Letters and Untitled Letters.  FDA issues Warning Letters to highlight alleged violations of the Federal Food, Drug, and Cosmetic Act that — if not appropriately resolved by the entity — may trigger … Continue Reading

The Cost of an Outbreak

ConAgra to pay $11.2 million in connection with Salmonella outbreak. In 2006-2007, Peter Pan peanut butter produced by ConAgra Foods, Inc. was recalled in connection with a nationwide Salmonella Tennessee outbreak.  The outbreak resulted in hundreds of infections and hospitalizations across 44 states.  The contamination ultimately was traced to plant and equipment conditions in a … Continue Reading

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