Regulatory
NDI Draft Guidance: Just When You Thought You Were Safe
If FDA can revoke the NDI status of vinpocetine as it considered doing this September, can it do the same to other ingredients, too?
BCM-95 Curcumin Receives GRAS Status for Medical Foods
DolCas Biotech says its BCM-95 turmeric extract is now self-affirmed GRAS in medical foods for doses up to 1000 mg per person per day.
How to Prioritize Potential NDI Notifications
FDA’s revised new dietary ingredient (NDI) draft guidance raises the specter of thousands of new NDI notifications. But which are most pressing?
How Should FDA Define the Word Natural? Should It Be Different from Organic? Or Non-GMO?
As FDA looks to define the term "natural" on food labeling, industry leaders are split on what exactly the term should mean.
New GMP Standard from NSF’s GRMA Nearly Complete
The Global Retailer and Manufacturer Alliance (GRMA) expects to release its new, ANSI-approved GMP standard for the dietary supplement industry in early 2017.
Waters Still Murky for Omega-3s in NDI Draft Guidance?
Nutritional Outlook interviewed the Global Organization for EPA and DHA Omega-3s to find out if conditions have improved at all for omega-3 firms under FDA's new NDI draft guidance document.
Would FDA’s NDI Guidance Really Cost Industry Billions of Dollars?
While some industry experts warn FDA is calling for tens of thousands of new NDI notifications, others anticipate the burden on industry will be more manageable.
Everyone Uses GRAS Panels These Days. But Is the System Working?
GRAS consultants discuss criticisms of GRAS experts.
Dietary Supplements: Made in the USA?
What does “Made in the USA” mean in a global age?
LactoSpore Probiotic Granted IBS Health Claim in Canada
The announcement comes just a few months after LactoSpore received a “no questions” letter from FDA regarding its Generally Recognized as Safe (GRAS) submission.
Grief over Grandfathered-Ingredient Lists
Would an official, FDA-created grandfathered list help or hurt the industry?
Is GRAS Still a Viable NDI Workaround?
Due to uncertainties over the NDI draft guidance, some wonder whether the popular GRAS system will still be a viable option for supplement manufacturers looking to exempt themselves from submitting NDI notifications to FDA.
Beta Testing Underway for CRN’s Supplement Product Registry
The new finished product registry, developed by Underwriters Laboratory, will be known as the Supplement Online Wellness Library (Supplement OWL).
Company Submits First NDI Master File to FDA. Plus, Will Master Files and Piggybacking Really Be Useful in Practice?
Questions still remain about how practical master files will be in practice.
FTC Charges Journal Publisher OMICS Group with Deceiving Researchers
The FTC alleges OMICS Group made false claims and failed to disclose steep publishing fees.
Whatever Happened to Common-Use GRAS?
Common-use GRAS determinations are no longer common.
Which Ingredient Categories Would Be Hit Hardest by FDA’s NDI Draft Guidance?
Some ingredient types, such as probiotics and synthetic botanicals, may have extra work on their hands as a result of FDA’s revised NDI draft guidance.
Smart Strategies for Marketing Brain-Health Products
Regulators are increasingly scrutinizing product claims in the booming brain-health market.
Charting the Path Forward on NDI Guidance in a Time of Industry Criticism
How should the dietary supplements industry respond to FDA's new dietary ingredient (NDI) draft guidance, especially in a time of negative criticism?
Negative Industry Attention from State Attorneys General May Be “Diminishing"
At the recent Conference of Western Attorneys General, a panel on the nutritional supplement industry reportedly took on a more positive tone than similar panels conducted last year.
Consulting Our Mates Down Under for NDI Guidance
Australia’s regulatory approach to botanical ingredient changes may inform U.S. companies as they prepare NDI draft guidance comments.
Medical Foods: Creating a Successful GRAS Notification
What’s the best way to ensure a GRAS notification for an ingredient’s use in medical foods will receive a “No Questions” letter from FDA?
FDA’s NDI Guidance Offers Reasonable Take on Ingredient Combinations, CRN’s Mister Says
FDA is “absolutely within its rights” to request a separate NDI notification for ingredient combinations, says CRN’s Steve Mister, and the burden on industry could be minimal.
How FDA’s NDI Guidance Could Paralyze Industry
UNPA points out several provisions in the new NDI draft guidance that could hamstring industry innovation.
4 Ways Brexit Could Affect the Supplement Industry
From maximum vitamin and mineral levels to the future of EFSA, speakers at the recent “Brexit Impact” webinar hosted by AHPA and CRN explain what companies should watch out for.
American Heart Association Issues Added Sugar Limit for Children
AHA recommends children aged 2–18 consume no more than six teaspoons of added sugars per day and limit consumption of sugary drinks to less than 8 ounces per week.
FDA’s NDI Guidance and GRAS Rule: Stop Fighting, and Move Forward
“To battle pointlessly only gives the industry’s critics further ammunition that we oppose any effort to rein in the bad actors that lurk around the fringes of the industry,” says CRN’s Steve Mister.
When in Doubt, Submit a NDI Notification, Urge NPA Webcast Speakers
Plus: Will FDA now step up its game of NDI enforcement?
Chemical Alteration in FDA's NDI Guidance “Will Impact Everyone”: Takeaways from Natural Products Association’s NDI Webinar
Industry should remain on high alert over whether FDA's "chemical alteration" language in its revised new dietary ingredient draft guidance will require a broad swath of industry companies to submit NDI notifications, expert says.
USP Launches Revamped Food Fraud Database
The second generation of USP’s Food Fraud Database includes added capabilities that make it easier for users to identify historical trends and vulnerabilities for food fraud.
