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.
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, said the head of a trade organization.
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 sites.
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 associated with added sugar, the new definition of dietary fiber, changes...
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 supplement.
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.
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 and never ending process.
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).
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 done to support the products.
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).
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.
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.
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 stance on the question of synthetic versions of constituents of botanicals.
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’ membership.
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 is not nearly as straightforward as was the case with...
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 new dietary ingredients (NDIs), and over-reach by the Federal Trade Commission...
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.
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 mode of communication with its customers.
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 and FTC standards.
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.
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.
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 up in the Supreme Court?
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 safety system – this time under the Executive...
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 and misbranded and adulterated dietary supplements.
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 vitamin C supplement.
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.
A court in California has approved a permanent injunction against a California dietary supplement company, driving yet another purveyor of DMAA from the market.
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.
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 The State of Obesity, which drew information from CDC's Behavioral...
Days after President Trump signed an executive order that freezes some regulations and draft guidance documents, FDA offers to help food industry associations draft their own guidance documents to help “capture the best practices” and boost industry compliance...
Amid reports that new products containing the banned stimulant ingredient DMAA continue to find their way onto the market one company has persisted in marketing them openly.
Quincy Bioscience, marketers of brain health product Prevagen, has been charged with making deceptive memory, cognitive improvement claims by the Federal Trade Commission and New York State Attorney General.
President elect Donald Trump campaigned on a program of redressing what he characterized as wrongs in the trade relationship between the United States and China. That stance, and his choice of a strident China critic for his cabinet, could present a problem...
A hotly-anticipated opinion by the US court of appeals for the ninth circuit in a high-profile false advertising case, contains bad news for defendant ConAgra Foods (now ConAgra Brands), but may prove to be of less significance to other food manufacturers,...
Requiring NDI notifications on almost every new product will create a situation in which few companies will be able to comply with the new draft guidance, the United Natural Products Alliance said.
Senator Claire McCaskill (D-MO) is frustrated with bureaucratic delays to the New Dietary Ingredient (NDI) draft guidance, and is calling on the FDA to quickly finalize the document.
The International Probiotics Association has urged the FDA to expanded the ‘grandfathered list’ of dietary ingredients to include bacterial strains globally recognized as used historically in foods.
The Natural Products Association has urged FDA to cease its attempt to apply food additive standards to dietary ingredients. To do so would create an undue burden on small business, many of which are represented by NPA.
Some proponents of botanicals such as kratom or CBDs have chafed under regulatory restrictions that have forestalled wider acceptance and availability. But the full market is potentially available for those companies willing to go through accepted channels,...
A recent presentation to FDA that was well received made the case that simple changes in fermentation media would not result in the creation of a New Dietary Ingredient.
Motivated by transparency, the US Food and Drug Administration has released tens of thousands of adverse event reports for dietary supplements, but does the data actually allow for any conclusions to be drawn?
A “clear and reasonable warning” must be used from December 4, 2016 on products being sold in California containing “Aloe vera, non-decolorized whole leaf extract” and “goldenseal root powder” compliant with Prop 65, unless otherwise exempted.
Dietary supplement retailer bodybuilding.com has asked the FDA to reaffirm the exemption that self-affirmed GRAS ingredients have from the NDI notification provision. The company has also suggested changes to the NDI master file idea and has asked the...
Regulatory definitions remain hazy for probiotics and prebiotics, but efforts are underway to further nail down where these ingredients fit within the overall structure that governs dietary supplements.
Organic industry stakeholders from across the nation are gathered in St. Louis today for what promises to be a highly contentious three-day meeting during which the National Organic Standards Board will debate the role of hydroponic production, carrageenan,...
From ‘doom to ‘more self-governance’, the prospect of a Trump presidency has provoked alarm and delight in equal measure. We asked you what a Trump presidency would mean for supplements and the results are in.
