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News > Regulation

Young Living fined for using illegally sourced essential oils, highlighting issue of supply chain transparency

Young Living, a multilevel marketing company that sells products based on essential oils, has entered into a plea agreement for illegally trading in oils from endangered species. The company will...

Amarin's ITC case against omega-3s players decried as attempt to corner EPA market

As the concentration levels of omega-3 dietary supplement products have steadily risen, pharmaceutical manufacturer Amarin has moved to protect its competitive turf by filing a trade complaint against a number...

FDA delays some safety requirements for produce under FSMA to make them less complicated, costly

FDA is pushing back the compliance dates for most agricultural water testing standards outlined in the Food Safety Modernization Act’s Produce Safety Rule to “simplify our approach to make compliance...

Special Edition: Personalized Nutrition

Personalization cracks open can of worms in manufacturing operations, experts say

True personalization of dietary supplements could run up against formidable manufacturing compliance challenges, consultants say.

Special Edition: Personalized Nutrition

Push toward personalization will create new legal risks to manage, experts say

Offering personalized dietary supplements could open manufacturers up to legal risks, some of which go beyond those they are already subject to, experts say.

ChromaDex-Elysium fight highlights glitches in NDI and GRAS processes

The tussle between ChromaDex and Elysium Health highlights again the curious dance between a New Dietary Ingredient Notification and a GRAS affirmation as a way to bring ingredients to market.

ChromaDex alleges in petition that Elysium Health product is adulterated

ChromaDex has taken the somewhat unusual step of filing a citizen’s petition with FDA alleging that Basis, the dietary supplement manufactured by Elysium Health, a one time customer, is adulterated...

Rimfrost says review of two of Aker's US patents gives it leverage

A ruling by the US Patent and Trademark Office has reignited the krill wars, with Norwegian company Rimfrost AS claiming the ruling could invalidate all of the claims relating to...

Guest article

Hey Siri, tell me about self-regulation

I’m often struck by how much our lives have changed now that smartphones have become such staples in modern society.

GanedenBC30 gets Health Canada ‘no objections letter,’ expanding formulation, claims flexibility for manufacturers

A new Health Canada ‘no objections letter’ expands manufacturers’ flexibility to formulate and market products with Ganeden’s branded Bacillus cogulans GBI-30, 6086 (or GanedenBC30 for short) in Canada. This includes...

Proper calibration, personnel training key to successful use of in-house testing equipment

A lack of identity testing is a frequent failure cited in warning letters issued by the Food and Drug Administration. But even when tests are being done, they need to...

ORAC values might be passé, but antioxidant activity still demands research, experts say

Quoting ORAC values as a marketing tool has gone the way of the dinosaurs. But the measure of antioxidant activity still points to potentially important beneficial properties of ingredients, experts...

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...

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...

NPA supports bill to allow WIC benefits to be used for multivitamins

Proposed legislation that would allow federal WIC benefits to be used to buy multivitamins could lead to better health outcomes for these embattled families, the Natural Products Association said last...

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.

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.

Red yeast rice product analysis misstates GMP issue, consultant asserts

A recent article on the variability of red yeast rice supplements provides valuable information but comes to a false conclusion, according to an expert on herbal supplements.

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...

Glyphosate joins Prop 65 list, but what does this mean for packaged food manufacturers?

Glyphosate (the active ingredient in Monsanto’s herbicide RoundUp) will be added to California's Prop 65 list on July 7, 2017, meaning warning labels will be required from July 2018. But what,...

Sports nutrition brands have lower SAE rates, expert says

Despite the perception that sports nutrition products tend to include ‘edgy’ ingredients, data suggest that these are among the safest of supplements, already a very safe category, an expert says,