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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,

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...

Guest article

Which Took Longer: Harry Potter or GMPs?

Ten years ago, in July 2007, I found myself at a midnight book party in Las Vegas for the release of Harry Potter & the Deathly Hallows. Even though I was...

Special edition: Botanicals

Synthetic botanicals standoff likely to continue despite Georgia ruling

Experts expect the existing standoff on synthetic botanicals as voiced by FDA in the most recent draft NDI guidance will continue, despite the consensus from industry being  the agency’s position...

NPA petitions FDA to shelve new nutrition, supplement facts labeling rule

Citing the Trump Administration’s policy to severely cut new and pending regulations, the National Products Association (NPA) petitioned the FDA to shelve the Obama-era proposed Nutrition and Supplement Facts labeling,...

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...

Breaking news

FDA extends compliance deadline for Nutrition Facts panel changes

As widely expected, the FDA is to extend the compliance dates for the Nutrition Facts label final rules to give manufacturers more time to prepare, although it has not yet...

Stakeholder group seeks consensus on dietary supplement quality practices

A collaborative group that includes stakeholders from across the industry is moving forward in an effort to define what is meant by ‘quality’ when referring to a dietary supplement.

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....

What is a probiotic? IPA releases guidance document on qualifying probiotics

The definition of probiotic varies by region, and an increasing number of products potentially mislabeled as “probiotic”. In response, the International Probiotics Association has released a guidance document.

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...

Raw material supply for CBDs increasing rapidly

Despite the continued uncertainty of the regulatory position of CBD products, the raw material supply of the ingredient is ramping up rapidly.

ABC puts out lab document on grapefruit seed extracts

The American Botanical Council has released another in its series of laboratory guidance documents, this one covering the controversial product grapefruit seed extract.

Warning letter emphasizes need for quality agreement with contract manufacturer

A recent FDA warning letter reinforces the idea that a quality agreement that covers all aspects of a contract manufacturing relationship—including the documentation aspect—is really a must-have for GMP compliance....

News in brief

SIDI Work Group releases updated protocol, calls for stakeholder comments

The SIDI Work Group, the dietary supplement industry’s self-regulatory coalition, has released an updated draft of its “Standardized Information on Dietary Ingredients (SIDI) Protocol”, and is calling for feedback from...

Knowing how FDA inspectors do their jobs, which is public info, will boost GMP compliance, expert says

Knowing the other team’s game plan can help ensure victory.  And this opportunity is open to dietary supplement companies when it comes to GMP compliance, an expert says.

ACI FOOD LAW FORUM: GMO labeling blues, Nutrition Facts delays, daily values and de-fortification, and will the FDA ever nail down natural?

Will the July 2018 deadline for compliance with the new Nutrition Facts panel stand? Will federal GMO labeling regulations stop GMO-related lawsuits? And will the FDA nail down ‘natural’ anytime...