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Regulations, Legislation & Enforcement

Regulations, Legislation & Enforcement

From FDA Warning Letters to injunctions from the Department of Justice, there's plenty of enforcement action to keep track of. In this category, we aggregate the most important news for regulatory and enforcement buffs.

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...

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...

News in brief

UNPA launches 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.

News in brief

CRN and AHPA collaborate on congressional advocacy for Day on the Hill

The American Herbal Products Association (AHPA) and the Council for Responsible Nutrition (CRN) are teaming up for a cooperative advocacy effort for a full day of face-to-face meetings with Congressional...

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....

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...

Jarrow challenges FDA on probiotics

Dietary supplement manufacturer Jarrow Formulas Inc. has filed a lengthy comment challenging FDA’s position on probiotics as set down in the most recent Revised Draft Guidance on New Dietary Ingredients....

AHPA urges EPA to revamp pesticide limits for botanicals

The American Herbal Products Association has urged federal regulators to revamp pesticide rules that unfairly impact minor crops that include many botanical commodities.

FDA inspectors realignment will boost enforcement, CRN says

The Council for Responsible Nutrition has joined in applauding FDA’s move to organize inspectors according to areas of expertise.

Bergstrom wants to take lead in setting record straight on MSM

Careful and consistent work on claims substantiation and a commitment to transparency has helped make Bergstrom a leader in the developing field of MSM,  a company executive said recently.

Trade groups welcome Gottlieb's FDA confirmation

Dietary supplement trade associations were quick to applaud the confirmation of Dr. Scott Gottlieb to lead the Food and Drug Administration.

FTC tells companies, 'influencers' to disclose when Instagram posts are ads

The Federal Trade Commission has sent 90 letters to brand holders and endorsers emphasizing the requirement to be forthright about business relationships on social media.

CRN’s support of Gottlieb rises above standard level

The Council for Responsible Nutrition has enthusiastically supported the nomination of Dr. Scott Gottlieb as FDA commissioner in a letter to Senators.

Herbalife shrugs off FTC, Ackman; boosts 2017 outlook

Herbalife has shaken off the lingering effects of a big-ticket settlement with the Federal Trade Commission with a relatively solid quarterly results statement that was welcomed by stock traders.

FDA uses warning letter to check up on DMAA recall

In an unusual move, in a warning letter to a dietary supplement company the Food and Drug Administration has sought information about a recall, in this case one involving DMAA...

Strain-level specificity critical for full compliance, NSF probiotics labeling expert says

Labeling probiotics to the strain level is becoming an increasing focus in NSF’s certification process, an expert told NutraIngredinets-USA.

News in brief

5-Hour Energy counterfeiter gets 7 years in federal prison

One of the primary defendants in the 5-Hour Energy counterfeit case, Walid Jamil, has been sentenced to seven years in prison and an additional three years of supervised release.

FDA sends out 14 warning letters in sweep on cancer claims

The U.S. Food and Drug Administration has sent warning letters to 14 companies this week about marketing products for illegal cancer claims.

More members of Congress understand supplements, CRN finds in its meetings with lawmakers

The word about the safety and efficacy of dietary supplements seems to be getting out, if the attitudes of freshman legislators in Washington DC is any measure. 

FDA nominee strongly affirms DSHEA during hearing

A staunch affirmation of DSHEA by Dr. Scott Gottlieb, MD the nominee for FDA commissioner, is a highly promising sign for the immediate prospects of industry cooperation with the agency,...

The potential of a delay to Nutrition Facts label changes should not slow compliance efforts

Assuming FDA does not delay the deadline for the new Nutrition Fact label as requested by industry, then large companies have slightly more than a year left to overcome challenges...

FDA culls huge number of foreign food facility registrations

In its latest cleanup of its food facility registration database, the U.S. Food and Drug Administration has culled an eye-opening 28% of existing registrations. The biggest drops happened in overseas...

Judge dismisses suit that questioned substantiation for Bayer's probiotic claims

Bayer has had what some observers called a “quick win” in the dismissal of a class action lawsuit filed in New Jersey over claims on its Phillips Colon Health probiotic...

CVS to institute new testing requirements for dietary supplements

As part of a corporate makeover, CVS Pharmacy says it intends to institute new standards for the dietary supplements it sells that will include specific testing requirements.

News that Chaffetz will step down part of continual search for support in Congress

The news that Rep. Jason Chaffetz plans not to seek re-election is a reminder that maintaining friends for the dietary supplements industry within the halls of power is an ongoing...

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