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Regulations, Legislation & Enforcement

Regulations, Legislation & Enforcement

From FDA Warning Letters to injunctions from the Department of Justice, there's plenty of enforcement action to keep track of. In this category, we aggregate the most important news for regulatory and enforcement buffs.

GAO argues again that the US should unite the 19 agencies that oversee food safety under one system

Citing an uptick in multi-state foodborne illness outbreaks and their high cost to consumers and manufacturers alike, the Government Accountability Office reiterates its 40-year argument for a single, unified food...

Court dismisses class action against CVS for vitamin C 'Made in USA' claims

A federal judge in the Northern District of Illinois has dismissed a putative class action against CVS Health Corp. and CVS Pharmacy, Inc. for “Made in USA” claims made on a...

Louisiana manufacturer hit with permanent injunction to stop distribution of adulterated supplements

The US Department of Justice has filed a proposed consent decree that permanently instructs Louisiana-based Pick and Pay, Inc./ Cili Minerals LLC to stop distributing misbranded and unapproved new drugs...

Testing failure, specification limits cited in FDA warning letters

A realistic testing regime and reasonable range on specified ingredient potencies were among the quality control issues cited by the Food and Drug Administration in recent warning letters.

Court issues permanent injunction against seller of DMAA

A court in California has approved a permanent injunction against a California dietary supplement company, driving yet another purveyor of DMAA from the market.

Have thousands of facility registrations lapsed?

A quirk of the latest go round in the FDA facility registration process means thousands of foreign firms could find their registrations have lapsed, a leading consultant tells NutraIngredients-USA.

What do acceptable claims in the blood sugar management category look like?

Diabetes is the seventh leading cause of death in the United States, and accounts for around $245 billion in medical costs and lost productivity each year, according to data from...

FDA offers to help industry draft guidance following Trump’s regulatory freeze

Days after President Trump signed an executive order that freezes some regulations and draft guidance documents, FDA offers to help food industry associations draft their own guidance documents to help...

Hi-Tech founder claims his devotion to DMAA is part of crusade against regulatory overreach

Amid reports that new products containing the banned stimulant ingredient DMAA continue to find their way onto the market one company has persisted in marketing them openly.

FTC outlines lessons for MLMs following Herbalife and Vemma cases

The Federal Trade Commission has released guidance for MLMs based on lessons learned from the FTC’s cases against Herbalife and Vemma.

Marketers of Prevagen charged with making false and unsubstantiated claims by FTC, NY AG

Quincy Bioscience, marketers of brain health product Prevagen, has been charged with making deceptive memory, cognitive improvement claims by the Federal Trade Commission and New York State Attorney General.

Concern verges on panic in supplement industry over Trump's China trade stance

President elect Donald Trump campaigned on a program of redressing what he characterized as wrongs in the trade relationship between the United States and China. That stance, and his choice...

ConAgra dealt blow by ninth circuit in '100% natural' case, but its wider significance is less clear, say experts

A hotly-anticipated opinion by the US court of appeals for the ninth circuit in a high-profile false advertising case, contains bad news for defendant ConAgra Foods (now ConAgra Brands), but...

IPA recommends expanded grandfathered list for probiotics

The International Probiotics Association has urged the FDA to expanded the ‘grandfathered list’ of dietary ingredients to include bacterial strains globally recognized as used historically in foods.

Sen McCaskill calls on FDA to quickly finalize NDI guidance

Senator Claire McCaskill (D-MO) is frustrated with bureaucratic delays to the New Dietary Ingredient (NDI) draft guidance, and is calling on the FDA to quickly finalize the document.

UNPA brands FDA's finished product focus in NDI guidance as unworkable and unlawful

Requiring NDI notifications on almost every new product will create a situation in which few companies will be able to comply with the new draft guidance, the United Natural Products...

NPA urges FDA to back off in applying food additive standards

The Natural Products Association has urged FDA to cease its attempt to apply  food additive standards to dietary ingredients. To do so would create an undue burden on small business,...

Experts recommend kratom & CBD players file NDIs first, before asking for new product category

Some proponents of botanicals such as kratom or CBDs have chafed under regulatory restrictions that have forestalled wider acceptance and availability. But the full market is potentially available for those...

FDA open to notion that new fermentation medium doesn't change probiotic identity, expert says

A recent presentation to FDA that was well received made the case that simple changes in fermentation media would not result in the creation of a New Dietary Ingredient.

FDA releases adverse events data for supplements, foods, and cosmetics

Motivated by transparency, the US Food and Drug Administration has released tens of thousands of adverse event reports for dietary supplements, but does the data actually allow for any conclusions...

News in brief

Prop 65 warnings for aloe vera, non-decolorized whole leaf extract & goldenseal root powder effective Dec 4, 2016

A “clear and reasonable warning” must be used from December 4, 2016 on products being sold in California containing “Aloe vera, non-decolorized whole leaf extract” and “goldenseal root powder” compliant...

Bodybuilding.com urges FDA to reinstate GRAS self affirmation exemption in NDI guidance

Dietary supplement retailer bodybuilding.com  has asked the FDA to reaffirm the exemption that self-affirmed GRAS ingredients have from the NDI notification provision. The company has also suggested changes to the NDI master...

Special edition: Pre & Probiotics

Effort underway to better fit probiotics into regulatory structure

Regulatory definitions remain hazy for probiotics and prebiotics, but efforts are underway to further nail down where these ingredients fit within the overall structure that governs dietary supplements.

NOSB debates organic status of carrageenan, tocopherols, marine algae, hydroponics

Organic industry stakeholders from across the nation are gathered in St. Louis today for what promises to be a highly contentious three-day meeting during which the National Organic Standards Board...

Linnea requests FDA to withdrawal vinpocetine notice

Ingredient supplier Linnea has added its voice to the vinpocetine issue, submitting comments requesting the FDA to withdraw the tentative conclusion that vinpocetine cannot be used as a dietary ingredient....

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