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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.

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...

Does FDA underestimate the time, resources spent on regulatory compliance?

The Food and Drug Administration is underestimating the amount of time and resources the supplement industry spends annually complying with government regulations, including current good manufacturing practices (cGMPs). 

Medical food marketer taken to task over IND filings on studies

Targeted Medical Pharma, a company marketing medical foods for pain management, has been hit with an FDA warning letter that illustrates the complexities of this product category and the studies...

Lifeway to 'vigorously defend' false ad lawsuit: 'Our kefir is 99% lactose free'

Lifeway Foods has vowed to defend itself “vigorously” against a lawsuit claiming it falsely advertised its fermented dairy products as ‘99% lactose free’ when they allegedly contained almost 4% lactose (milk sugar).

Panel: Consumers don't understand much about quality

Setting high quality standards is one thing.  But making that pay?  That’s not so easy, said participants at a recent dietary supplement industry meeting.

Adverse events database not useful for drawing safety conclusions, expert says

The carte blanche release of adverse events data could give a skewed view of the safety of the dietary supplement industry, one expert says.

Quirks in regulations create need for science-based pesticide limits, USP says

Quirks of regulatory policy regarding pesticides leave botanical dietary supplement ingredients subject to unwarranted seizure, attendees at an international botanical conference in Mississippi were told.

FDA prevails over Hi-Tech on DMAA, but ruling could open door on synthetic botanicals

A federal district court judge in Atlanta has ruled in favor of FDA in its case against Hi-Tech Pharmaceuticals over its use of DMAA. But the ruling potentially weakens agency’s...

AHPA, CRN suggest tweaks, wholesale overhauls of manufacturing regs

A call from the U.S. Commerce Department for suggestions on streamlining manufacturing regulations has generated responses from industry trade organizations, with the different tacks the suggestions take reflecting those organizations’...

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