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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.

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...

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Senator Claire McCaskill (D-MO) is frustrated with bureaucratic delays to the New Dietary Ingredient (NDI) draft guidance, and is calling on the FDA to quickly finalize the document.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on almost every new product will create a situation in which few companies will be able to comply with the new draft guidance, the United Natural Products...

IPA recommends expanded grandfathered list for probiotics

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

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

Dietary supplement retailer  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....

Trump: Good or bad news for the supplements industry? (Our survey results are in)

From ‘doom to ‘more self-governance’, the prospect of a Trump presidency has provoked alarm and delight in equal measure. We asked you what a Trump presidency would mean for supplements...

‘Pro business’ is best guess when looking at character of Trump administration

Donald Trump’s historic victory leaves dietary supplement industry observers wrestling with the question of what will be the character of his administration, when the candidate himself has taken so many...

13 things we learned from the IPA’s DC Workshop

From market sizing to the positions from FDA and FTC on NDIs and claims substantiation, the International Probiotic Association’s DC workshop succeeded in providing a venue for sharing knowledge and...

Ten things to change about DSHEA

If you could change one thing about the Dietary Supplements Health & Education Act, what would it be? Ten industry lawyers weighed in…

Senator Hatch urges withdrawal of vinpocetine notice

Dietary supplement champion Sen Orrin Hatch (R-UT) is calling for the withdrawal of a Federal Register Notice that questioned the regulatory status of vinpocetine as a new dietary ingredient.

Supplement OWL product registry ready to accept product labels

The much anticipated Supplement OWL (Online Wellness Library) – a product label database – is moving into the second phase of beta-testing and is now accepting product labels from dietary...

CRN to Health Canada: Don't try to fix NHP system if it ain't broke

The Council for Responsible Nutrition has submitted comments to a Health Canada that urges the agency not to scrap the existing product registration system but rather to further refine it...

Prop 65 private enforcers are just getting warmed up, attorney warns

The pace of Prop 65 suits in California continues to be brisk and settlement demands have been increasing, said a lawyer who represents dietary supplements in these actions.

Workshop to explore the impact of NDI draft guidance, final GRAS rule for probiotics

A workshop hosted by the International Probiotics Association (IPA) in Washington, DC will tackle some of the key issues facing the probiotics sector, including positions from FDA and FTC on...

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