Breaking News on Supplements, Health & Nutrition - North AmericaEU edition

Trends > GMPs, QA & QC

Supplement firm still in operation despite slew of disease claims, GMP violations

A warning letter issued last month to dietary supplement firm Sound Healing Arts illustrates what’s wrong with the current enforcement picture at FDA, says an industry observer.

CRN exploring development of registry of dietary supplements

The Board of the Council for Responsible Nutrition has adopted the proposal to move forward with a registry of dietary supplements, which could be a relatively quick process if an...

Special edition: Regulatory Focus

Sharfstein floats new regulatory framework dialing in on safety and backing off on claims

Former FDA official Dr Joshua Sharfstein, MD, has proposed a new paradigm for the regulation of dietary supplements. The underlying shift would be a move from an attitude of “benefit...

Special Edition: Regulatory Focus

Federal court rebuffs FTC effort to apply pharmaceutical standards to dietary supplement substantiation

The decision in the Bayer Corp. contempt case has important implications for the dietary supplement industry, say attorneys Steven Shapiro and Marc Ullman in this guest article: 

USP launches new GMP audit certification program

There’s a new player in the GMP audit sector, with the United States Pharmacopeial Convention (USP) expanding its verification services to include a new GMP audit program for dietary supplement...

Alkemist Labs rolling out Next Generation Sequencing DNA testing

Costa Mesa, CA-based Alkemist Labs is adding Next Generation DNA Sequencing to its arsenal of testing capabilities, in response to customer demand for the technology.

GNC stock price plunges 28% after disappointing Q3 earnings report

GNC’s stock value took a significant hit following the release of disappointing third quarter earnings. The company finds itself between the rock of investigations by state attorneys general and the...

ProcessPro says GMP compliance concerns boosting demand for its software

With the increasing emphasis on GMP compliance, companies like ProcessPro, a Minnesota-based provider of software solutions for manufacturers, has seen an increasing demand for its services.

BASF: Transparency and quality are great opportunities

The shifting landscape of dietary supplements and increasing scrutiny by the media, regulators and consumers is driving the need for greater transparency and quality, says BASF’s human nutrition business director....

Oregon AG suit raises risk for ingredients with fuzzy legal standing, experts say

The lawsuit filed by the Oregon Attorney General raises overall risk for the supplements industry and could mean that a number of niche ingredients could disappear from the market, experts...

Special edition: Regulatory Focus

FSMA addresses a gap between dietary supplements and dietary ingredients

Attorney Jason Sapsin shows how new FSMA rules apply directly to dietary ingredient firms that were exempted from GMP requirements that apply to supplement companies.

Multivitamins, cognitive health, and DNA analysis: CRN's Day of Science 2015 as it happened

The Council for Responsible Nutrition's Day of Science took place on October 21 in Palm Springs, CA, with hot topics covering everything from learnings from PHS II, nutrition and cognitive...

Special edition: Regulatory Focus

Firm has automated solution to ease GMP documentation burden

Complying with the paperwork required by full GMP compliance has proved to be a headache for dietary supplement companies.  Procedures automation firm Instant GMP can help.

Fabricant: “We have to stay vigilant; FTC is not going away”

The recent Bayer victory in its case with the FTC is a positive for industry, but it is not going to solve all of the industry’s FTC problems, says Dr...

Schneiderman pushed industry to ramp up quality game, Blumenthal said

The attacks on the dietary supplement industry orchestrated by New York Attorney General Eric Schneiderman have had beneficial effect, said American Botanical Council founder Mark Blumenthal. There is no denying...

Alkemist/AHP deal part of renewed focus on quality, availability of botanical reference materials

Marketing botanical reference materials (BRMs) is no way to get rich. But that hasn’t stopped some in industry, such as Alkemist Labs, from offering an expanded line of these products...


Hollowed out news organizations less able to report in thoughtful manner on supplements industry

Fundamental changes in the media landscape are affecting how reporters cover the natural products and dietary supplement industries.  Employment at media outlets has fallen steeply, meaning reporters have less time...

FDA’s Welch: ‘We are not seeing the drastic jumps in GMP compliance that we would like to see’

With about 50% of the industry's facilities inspected, GMP compliance is largely not where the FDA would want it to be, said the Agency's Dr Cara Welch. 

Is DNA barcoding now the adulteration tool du jour?

The NY Attorney General’s focus on DNA barcoding may actually be making quality worse, says Frank Jaksch, CEO of ChromaDex, and the focus should be on supply chain management and...

Challenge growing to ensure supply in a changing world, congress attendees told

Change is a constant in the natural world, but it is accelerating for a variety of reasons, a fact that has serious implications for botanical ingredient suppliers, participants at a...

FDA's Welch says it's time to find way to acknowledge industry's GMP successes

Cara Welch, PhD, acting deputy director of the Division of Dietary Supplement Programs at the Food and Drug Administration, signaled a change in emphasis at the agency with a willingness...

Sen McCaskill calls for vinpocetine and picamilon supplements to be pulled from shelves

Senator Claire McCaskill, the ranking member of the US Senate Special Committee on Aging, has called for the FDA to suspend sales of supplements containing vinpocetine and picamilon pending an...

GMP compliance improving based on expert's analysis of 483 issues & inspection outcomes

Preliminary data from 2015 presented at a recent industry forum indicate that the Food and Drug Administration is issuing fewer 483s and the issues generating these observations during inspections are...

FDA: Picamilon is not a dietary ingredient

Dietary supplements containing picamilon are considered adulterated by the US Food and Drug Administration, because picamilon is not a legal dietary ingredient, the Agency has told NutraIngredients-USA.

Finding the right endorsers & mixing the right proteins are part of winning in sports nutrition game, say experts

Opportunities abound in the growing sports nutrition market, speakers on NIU’s recent forum told listeners. The forum, available on demand, covered topics of marketing, formulation and label transparency.

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