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GMPs, NDIs, and definitions for GMO and natural: NPA’s Fabricant on industry issues

Despite ongoing vacancies in the main office of the Division of Dietary Supplements, companies must continue to build relationships with FDA’s district offices to ensure ongoing GMP compliance, says Dr...

Insights from SupplySide West

Adverse event reporting can provide valuable data to companies, expert says

Reporting adverse events is something all dietary supplement companies must prepared to do to be in compliance with the law.  But beyond that basic requirement, companies that fully embrace an...

Fine print of GMP compliance still a mystery to many small manufacturers, expert says

The smallest tier of dietary supplement manufacturers still, as a class, lack comprehensive understanding of GMP requirements, according a digital solutions provider.

NPA, CRN file Amicus Briefs to challenge FTC’s action against Bayer

The Natural Products Association and the Council for Responsible Nutrition are “concerned” by the recent FTC motion against Bayer for claims made for its probiotic dietary supplement, Phillips’ Colon Health, and have...

Trade associations remind industry: ‘Dietary supplements cannot claim to cure or prevent Ebola’

The five trade associations for the US dietary supplements industry have issued a joint statement to remind consumers and retailers that dietary supplements cannot claim to cure or prevent Ebola.

Months after issuing import ban, FDA still working to get kratom off market

Kratom continues to be imported into the US in large quantities and marketed as a dietary supplement. And some supplies of this botanical may be laced with dangerous undeclared pharmaceutical...

AHPA’s proposed consumer friendly Prop 65 label warnings gain traction among regulators

Proposals from the American Herbal Product Association (AHPA) to allow more informative warnings for California’s Proposition 65-listed reproductive toxins have been met with interest by the California Office of Environmental...

KGK Synergize to launch GMP auditing firm

Contract research organization KGK Synergize Inc. is broadening the scope of its expertise with the formation of a new company called GMP Auditing Partners and has named industry veteran Ed...

FTC warns 60 companies for noncompliance on ad disclosure guidelines

The Federal Trade Commission has sent warning letters to 60 companies, including 20 of the nation’s largest advertisers, warning them about their failure to make adequate disclosures in their print...

Regulatory roadblocks to AquaBounty's GE salmon ‘seriously damage the global credibility of FDA and its objective, science-based approval process’, warn scientists

90 scientists have written to President Obama urging him to press the FDA into making a decision, one way or another, on whether AquaBounty Technologies should be allowed to introduce...

House passes Designer Anabolic Steroid Control Act... now for the Senate?

The Designer Anabolic Steroid Control Act (DASCA) of 2014 (H.R. 4771) has passed the U.S. House of Representatives, a move praised by the Council for Responsible Nutrition (CRN).

Rock Creek seems to be near end of supplement road as FDA rejects NDI filing

Rock Creek Pharmaceuticals, formerly known as Star Scientific, has hit another pothole in the road in the form of a negative opinion from the Food and Drug Administration on its...

Ullman on Bayer-FTC issue: ‘Be as careful with your implied claims & testimonials as you are with the express claims’

The US Federal Trade Commission’s motion against Bayer for claims made for its probiotic dietary supplement, Phillips’ Colon Health “warrants close monitoring” because of the potential wide-ranging implications, according to...

AHPA issues recommendations on cannabis regulation

The American Herbal Products Association continues to help lead the conversation about cannabis with the issuance of recommendations to regulators on the best practices for production and consumption of the...

Bayer ‘extremely disappointed & strongly disagrees’ with FTC/DoJ allegations against Phillips’ Colon Health claims

Healthcare giant Bayer has said it will defend itself ‘vigorously’ against the US Federal Trade Commission decision to bring a motion against the company for claims made for its probiotic...

News in brief

FTC permanently bans marketer from weight loss industry

The head of a marketing organization has been permanently banned from the weight loss industry in a settlement with the Federal Trade Commission.

GOED confident of success with omega-3 – blood pressure health claim

A health claim petition filed by the Global Organization for EPA and DHA Omega-3s (GOED) with the US Food and Drug Administration (FDA) has been opened for public comment.

FTC levies $3.5 million fine against green coffee bean extract supplier

Applied Food Sciences, a Texas-based ingredient supplier, has agreed to pay $3.5 million to settle a complaint brought by the Federal Trade Commission over what the FTC said was a...

International association endorses Botanical Adulterants Program

A major self policing and informational effort in the dietary supplement industry has received a signifcant boost on the international stage.  The Botanical Adulterants program, a coopertive venture of three...

NBTY sued over allegedly pumping up protein claims for whey product

As observers of the class action lawsuit game had predicted, lawsuits based on alleged protein spiking are starting to pile up, and an initial target is one with deep pockets:...

Is FDA doing enough to stem tide of tainted products? Probably not

A review of recent FDA enforcement actions concerning tainted products marketed as dietary supplements highlights the scope of the problem facing regulators and the limitations they operate under in dealing...

Reaction to FDA's proposed Nutrition Facts updates

AHPA to FDA: Clarify protein labeling

Although it generally supports the Food and Drug Administration’s (FDA) proposed Nutrition and Supplement Facts label changes, the American Herbal Products Association (AHPA) urged the agency to adopt the Digestible...

AHPA's data shows FDA ramping up enforcement on tainted weight loss, sex products

The presence of undeclared pharmaceutical ingredients in products purporting to be dietary supplements is garnering an increasing amount of attention and enforcement from the Food and Drug Administration, databases compiled...

FTC's fines on weight loss claims total more than all other categories combined, CRN database shows

The Council for Responsible Nutrition has launched a new tool for members that puts together in one place data on recent enforcement actions by the Federal Trade Commission regardling claims...

CRN-I aims for new audience with supplement quality seminar set in Australia

The Council for Responsible Nutrition — International will reach a new audience with its annual supplement quality seminar with this year’s event set for Brisbane, Australia in October.

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