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Consumer Product Matters A product safety and consumer related regulation and litigation blog

Tag Archives: Federal Food Drug and Cosmetic Act

Cosmetics Reform Activity Begins in the 115th Congress

Posted in Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Manufacturer Product Safety, Private Labeler Product Safety, U.S. Congress, Uncategorized

As we have discussed in previous posts, Congress may be moving towards finally enacting some long-awaited cosmetics reform legislation this year. On January 13, Representative Pete Sessions (R-TX) reintroduced his cosmetics modernization bill as H.R.575. The package of reforms was first introduced in November 2015 as the Cosmetic Modernization Amendments of 2015 (H.R.4075). Overall, the proposed legislation would amend… Continue Reading

Coming Soon to a Lawbook Near You – New Cosmetic Requirements

Posted in Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Manufacturer Product Safety, Private Labeler Product Safety, U.S. Congress

Back in April 2015, Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) introduced the Personal Care Products Safety Act (S.1014).  More recently, on September 22, 2016, the Senate Health, Education, Labor, and Pensions Committee received testimony from Senators Feinstein and Collins in support of this bipartisan legislation.  The HELP Committee also heard from experts in… Continue Reading

Administration’s Biotechnology Working Group Updates Coordinated Framework & Unveils National Strategy

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Manufacturer Product Safety, Uncategorized

After launching with an ambitious agenda fourteen months ago (as we wrote about here), last Friday the Obama Administration announced that its Biotechnology Working Group had completed its two main tasks.  The Working Group has proposed an Update to the Coordinated Framework for the Regulation of Biotechnology, and it also completed work on a National Strategy for Modernizing the… Continue Reading

Eighth Circuit Issues Decision Significant for All Executives of FDA-Regulated Businesses

Posted in Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Litigation, Manufacturer Product Safety

On July 6, 2016, the Eighth Circuit Court of Appeals issued its ruling in United States v. DeCoster, in which it upheld prison sentences for two executives under the “responsible corporate officer” (RCO) doctrine of liability, also called the Park doctrine, for their role in introducing into interstate commerce eggs that had been adulterated with… Continue Reading

FDA Finally Decides that “Evaporated Cane Juice” Is Misleading Consumers

Posted in Advertising, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage

Evaporated cane juice, a term usually used to inform about sweeteners derived from the fluid extract of sugar cane, is present on the ingredient lists of many products we see on grocery store shelves. However, newly finalized FDA guidance on use of the term “evaporated cane juice” (“ECJ”) as an ingredient in food labels may… Continue Reading

Maple Syrup Trade Organization Seeks FDA Regulation of “Maple” Products

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage

I haven’t met many people who don’t love maple syrup. Its versatility knows few bounds – traditional pancake or waffle topper, lemonade, salad, and doughnuts come to mind. As you might imagine, the maple syrup industry actively works to protect its product, especially when it comes to alleged imposters.

“Multi-Agency Interactive Tool” Available for Developers of Health Apps

Posted in Advertising, Federal Regulations, Federal Trade Commission (FTC), Food & Drug Administration (FDA)

It seems as though 2016 may become the year that industry receives a plethora of helpful interactive portals from Federal Agencies.  My colleague Matt Cohen recently reported on the existence of a new CPSC tool called The Regulatory Robot that’s helping businesses identify the product safety rules that might apply to a new product.  This week, the Federal Trade Commission (FTC) — in conjunction with the Food… Continue Reading

Fraudulent Dietary Supplements Highlighted in the 2016 National Consumer Protection Week

Posted in Consumer Product Safety, Drugs & Cosmetics, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage

In case you hadn’t heard about it or didn’t get involved in any of the events hosted by various campaign members, the week of March 6-12 was National Consumer Protection Week.  Besides the usual efforts to educate the public about our basic rights as consumers, the risks of identity theft, and certain types of scams such as… Continue Reading

Agencies Engaged in Federal Biotech Overhaul to Host Final Two Public Sessions in March

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Manufacturer Product Safety

After hosting the first of three stakeholder meetings late last year, federal government agencies engaged in overhauling the 1986 Coordinated Framework for the Regulation of Biotechnology recently announced that meetings two and three will take place on March 9 and March 30 in Dallas, Texas and Davis, California, respectively. These meetings are an integral part… Continue Reading

“Just Mayo” Maker Convinces FDA That a Different Label Doesn’t Have to Include a Different Name

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage

Back in September we blogged about the Warning Letter that FDA issued to Hampton Creek Foods, Inc. for its vegan food dressing and sandwich spread, “Just Mayo” and a similar product, “Just Mayo Sriracha.”  In addition to several other interesting labeling violations, FDA noted that “Just Mayo” was not mayonnaise as defined by federal regulations because it… Continue Reading

FDA Finalizes Genetically Engineered Food Labeling Guidance & Approves “AquAdvantage Salmon”

Posted in Food & Drug Administration (FDA), Food and Beverage

Last week will undoubtedly be marked in the annals of Food and Drug Administration history as an important milestone for the Agency. On November 19, 2015, FDA approved the first genetically engineered (GE) animal intended for use as human food – AquaBounty Technologies’s AquAdvantage Salmon, a transgenic Atlantic salmon that contains a growth hormone gene… Continue Reading

Three More FSMA Rules Finalized As the Year Comes to a Close

Posted in Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Importer Safety, Manufacturer Product Safety, Private Labeler Product Safety, Product Liability, Supply Chain Risk Management

Although not quite meeting the deadline of October 31 established in a legal settlement last year, FDA has released a set of three more “foundational” Final Rules mandated by the Food Safety Modernization Act (FSMA or the Act). The Final Rules on Foreign Supplier Verification Programs, produce safety, and accredited third-party certification were released by… Continue Reading

Are Cosmetics Gaining Higher Congressional and FDA Scrutiny?

Posted in Federal Regulations, Food & Drug Administration (FDA)

Written by: Michelle Gillette and Katherine Fox Currently, FDA regulates cosmetics to ensure they are not adulterated or misbranded, but does not have the authority to order cosmetic recalls or require adverse event reporting.  Senators Dianne Feinstein (D-CA) and Susan Collins (R-ME) seek to change that. On April 20, 2015, they introduced the Personal Care… Continue Reading

FDA Increasing Scrutiny of Cosmetic Marketing Claims, New Agency Warnings Suggest

Posted in Advertising, Food & Drug Administration (FDA)

In addition to truthful and non-misleading advertising requirements, which are enforced by the FTC and certainly familiar to readers of this blog, personal care and cosmetic products are also subject to the Federal Food, Drug, and Cosmetic Act (the Act) and may run afoul of the U.S. Food and Drug Administration (FDA or the agency)… Continue Reading

Guilty Convictions in Salmonella Trial May Signify Landmark in Criminal Food-Safety Prosecutions

Posted in CPSC Civil Penalties, CPSC Enforcement Actions, CPSC Product Recalls, Federal Regulations, Food & Drug Administration (FDA), Food and Beverage, Litigation, Manufacturer Product Safety, Product Liability, State Product Safety Laws, State Regulations, Uncategorized

This space has thoroughly explored the various forms of civil liability food companies face for the mislabeling and/or deceptive marketing of their products.  Last week, a set of landmark convictions in a criminal food-safety prosecution potentially signal increased criminal liability for food companies when matters of public health and safety are at play… On Friday, September 19, 2014, a federal… Continue Reading