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Trends > GMPs, QA & QC

Trade associations unanimous in support of DoJ/FTC/FDA crackdown

Dietary supplement trade associations have universally welcomed the Department of Justice’s nationwide sweep targeting more than 100 makers and marketers of dietary supplements for alleged fraudulent ingredients and illegal claims.

There's no easy answer to question of which test methods to use, forum attendees told

Despite pressure on the industry to rapidly adopt some form of DNA testing, the old question still remains:  Methods must be fit for purpose for the products being tested.  Attendees...

In-house labs make sense in era of mounting pressure on supply chain, NOW Foods' Secrist says

The mounting pressure on supply chain verification means it’s time for more companies in the dietary supplements industry to consider building and staffing their own labs, said NOW Foods exec...

DNA tests still lack the kind of certainty the public expects, researcher says

DNA is a potentially powerful technology that has pitfalls for botanical identification, attendees at a recent industry event were told.

GNC lays out initiative for supplement industry meant to recapture quality narrative

GNC laid out a blueprint for the dietary supplement industry for a quality initiative including pre-market product registration at a meeting last week in Salt Lake City. The initiative builds...

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...

Opinion

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...