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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.

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’...

Acacia rigidula still popping up on market

Acacia rigidula-containing products continue to find a place in the market, as a recent warning letter shows. 

PEAs harder to control than were steroids, experts say

The presence and proliferation of phenylethylamines in sports nutrition products continues to be a thorn in the side of the dietary supplement industry.  But trying to regulate these ingredients away...

Natural Products Day: NPA discusses HSA/FSA, NDIs, FTC, WIC program and more with legislators

Over 100 industry stakeholders from 25 key states took to Capitol Hill to discuss a range of issues, ranging from the inclusion of dietary supplement in HSA/FSA, the regulation of...

Colorado supplement firm shut down over repeated GMP failures

A Colorado-based distributor of dietary supplements has received a permanent injunction as a result of repeated GMP violations that spanned more than four years.

In wake of disease claim warning, Life Extension said it will tweak page layouts but won’t back down from core mission

Despite receiving a warning letter from the Food and Drug Administration about disease claims on its website, supplement manufacturer Life Extension said it is not going to change its basic...

Blood Sugar Management Forum recap: Common pitfalls in marketing and labeling

Marketing the benefits for supplements in the blood sugar management category is a matter of carefully crafting claims to make sure there’s substantiating science, and that claims comply with FDA...

NPA shrinks board with new bylaws, expands membership categories

The Natural Products Association has approved a bylaw change that will shrink the size of the group’s board from 22 to what the group’s CEO calls a more manageable nine....

Industry awaits fallout of potentially big tax and tariff changes under GOP leadership

Questions of border walls, new tariffs and the volatile nature of the Trump Administration has companies in the dietary supplements industry anxiously reading the tea leaves of tax policy.

Will the ConAgra 100% natural case end up in the Supreme Court?

POM v Coke got there, but will another high-profile food litigation case – this time over GMOs and 100% natural labels on cooking oil (Briseno v ConAgra) - also end...

GAO argues again that the US should unite the 19 agencies that oversee food safety under one system

Citing an uptick in multi-state foodborne illness outbreaks and their high cost to consumers and manufacturers alike, the Government Accountability Office reiterates its 40-year argument for a single, unified food...

Court dismisses class action against CVS for vitamin C 'Made in USA' claims

A federal judge in the Northern District of Illinois has dismissed a putative class action against CVS Health Corp. and CVS Pharmacy, Inc. for “Made in USA” claims made on a...

Louisiana manufacturer hit with permanent injunction to stop distribution of adulterated supplements

The US Department of Justice has filed a proposed consent decree that permanently instructs Louisiana-based Pick and Pay, Inc./ Cili Minerals LLC to stop distributing misbranded and unapproved new drugs...

Testing failure, specification limits cited in FDA warning letters

A realistic testing regime and reasonable range on specified ingredient potencies were among the quality control issues cited by the Food and Drug Administration in recent warning letters.

Court issues permanent injunction against seller of DMAA

A court in California has approved a permanent injunction against a California dietary supplement company, driving yet another purveyor of DMAA from the market.

Have thousands of facility registrations lapsed?

A quirk of the latest go round in the FDA facility registration process means thousands of foreign firms could find their registrations have lapsed, a leading consultant tells NutraIngredients-USA.

What do acceptable claims in the blood sugar management category look like?

Diabetes is the seventh leading cause of death in the United States, and accounts for around $245 billion in medical costs and lost productivity each year, according to data from...

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