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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.

Colorado CBD brand takes aim at national specialty retail distribution

Colorado-based brand NuLeaf Naturals is expanding its distribution footprint beyond online sales into brick and mortar retail for its line of CBD products.

Food trade associations press OMB on GMO labeling timetable in a bid to avoid 'extended regulatory uncertainty'

Trade associations including the Food Marketing Institute and the Grocery Manufacturers Association have warned the Office of Management and Budget (OMB) that failing to implement federal GMO labeling legislation in...

Despite legal dispute over memory claims, Quincy Bioscience still spends big on promotion

Despite a high profile legal wrangle with FTC and with the New York Attorney General, memory support supplement manufacturer Quincy Bioscience has enough revenue in the tank to afford a...

Rep. Mia Love joins changing leadership ranks of Dietary Supplement Caucus

The Dietary Supplement Caucus, an ever-fluid assembly of lawmakers who support the industry, has a new leader in the form Rep. Mia Love, R-UT, who will take over the co-chair...

CRN official finds common ground with author of series of articles attacking industry

When looking at a potentially damaging series of journal articles about supplements being penned by a professor at Clemson University, an official at CRN prefers to look at the common...

Herbalife sales decline as FTC agreement nears full implementation

Network marketing giant Herbalife showed an increase in profits but a drop in overall revenue as it works to fully implement the conditions of its settlement with the Federal Trade...

Ethical Naturals uses extraction expertise on new monk fruit sweetener

Seeing a looming opportunity, dietary ingredients supplier Ethical Naturals has brought a new monk fruit sweetener ingredient to market that it says uses the same technology that it applies to...

News in brief

ASAE honors Supplement OWL with Power of A Silver Award

The American Society of Association Executives (ASAE) has awarded the Supplement OWL (Online Wellness Library) a 2017 Power of A Silver Award.

FTC, FDA ask consumers directly for help on policing claims, reporting adverse events

In a communication earlier this week two regulatory agencies sought input directly from consumers about outlandish claims and adverse events relating to dietary supplements. 

Warning letters take note of herbal nomenclature, expert says

Making a mistake on an ingredient name can result in a specific call out on a warning letter, an expert cautions.

Brazilian researchers find high amounts of caffeine, some drugs, in seized supplements

Caffeinated weight loss supplements that have been seized by the Brazilian Federal Police were analyzed. Investigators found that some contained up to 120% more caffeine that stated on the packaging.

Special edition: Cognitive Health

Strict adherence to science backing only way to avoid memory claim pitfalls, experts say

Helping consumers maintain healthy memory function is one of the peaks many dietary supplement formulators seek to climb.  And it is one of the most likely targets for regulatory enforcement...

CRN to extend medical foods membership in effort to help define category

What can properly be called a medical food?  The Council for Responsible Nutrition wants to help frame the answer to that question.

News in brief

One week to go: UNPA hosts PCQI training for dietary supplement companies

The United Natural Products Alliance (UNPA) is launching a new training course, “Preventive Controls Workshop for Dietary Supplements: PCQI Training for Dietary Supplement Companies”, but spaces are limited.

FDA continuing to drill down to provenance of ingredients

Recent warning letters show the Food and Drug Administration continues to hone in on the provenance of ingredients, and demonstrate that the tempo of enforcement remains unchanged despite the moves...

Soccer star makes case for supplements on Capitol Hill

The recent briefing for members of the Dietary Supplement Caucus featured an appearance by a world-class athlete speaking in favor of supplementation.

Navigating disease claim currents especially tricky for probiotics, expert says

Regulatory hurdles must be kept in mind when designing studies to support products. This is especially true in research on probiotics, an expert says.

Fruit d' Or gets Health Canada approval for cranberry powder during period of regulatory uncertainty

Fruit d’ Or has obtained a Health Canada designation for its cranberry juice powder which comes with it the ability to make health claims on urinary tract infections. The approval...

GAO’s memory supplement review

‘Agencies need to do more around the most egregious memory claims’: CRN’s Mister

The majority of dietary supplements making memory claims adhere to the federal requirements but some still go too far with their claims, according to a new review from the US...

News in brief

CRN and AHPA collaborate on congressional advocacy for Day on the Hill

The American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN) are teaming up for a cooperative advocacy effort for a full day of face-to-face meetings with Congressional...

UNPA endorses the Supplement OWL

The Supplement OWL is “an important and necessary first step towards transparency”, said Loren Israelsen, president of the United Natural Products Alliance (UNPA) following his organization’s endorsement of the initiative....

Soup-To-Nuts Podcast: FDA & FTC move forward with enforcement even with some regulations in limbo

New regulations and draft guidances may be on hold at many federal agencies until the Trump administration can find its footing, but enforcement by FDA, FTC and USDA is not...

Jarrow challenges FDA on probiotics

Dietary supplement manufacturer Jarrow Formulas Inc. has filed a lengthy comment challenging FDA’s position on probiotics as set down in the most recent Revised Draft Guidance on New Dietary Ingredients....

AHPA urges EPA to revamp pesticide limits for botanicals

The American Herbal Products Association has urged federal regulators to revamp pesticide rules that unfairly impact minor crops that include many botanical commodities.

FDA inspectors realignment will boost enforcement, CRN says

The Council for Responsible Nutrition has joined in applauding FDA’s move to organize inspectors according to areas of expertise.