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.
Ingredient supplier Linnea has added its voice to the vinpocetine issue, submitting comments requesting the FDA to withdraw the tentative conclusion that vinpocetine cannot be used as a dietary ingredient.
Donald Trump’s historic victory leaves dietary supplement industry observers wrestling with the question of what will be the character of his administration, when the candidate himself has taken so many positions, some of which match standard conservative...
From market sizing to the positions from FDA and FTC on NDIs and claims substantiation, the International Probiotic Association’s DC workshop succeeded in providing a venue for sharing knowledge and expertise.
Dietary supplement champion Sen Orrin Hatch (R-UT) is calling for the withdrawal of a Federal Register Notice that questioned the regulatory status of vinpocetine as a new dietary ingredient.
The much anticipated Supplement OWL (Online Wellness Library) – a product label database – is moving into the second phase of beta-testing and is now accepting product labels from dietary supplement finished product manufacturers and marketers.
The Council for Responsible Nutrition has submitted comments to a Health Canada that urges the agency not to scrap the existing product registration system but rather to further refine it if that is deemed necessary and to better educate the public about...
The pace of Prop 65 suits in California continues to be brisk and settlement demands have been increasing, said a lawyer who represents dietary supplements in these actions.
A workshop hosted by the International Probiotics Association (IPA) in Washington, DC will tackle some of the key issues facing the probiotics sector, including positions from FDA and FTC on NDIs and claims substantiation.
The Food and Drug Administration should include colony forming units or CFUs for probiotic labeling, says Amy Smith from DuPont, with a citizen’s petition a possible avenue for the change.
Companies large and small have been beta-testing the CRN’s product registry – the Supplement Online Wellness Library (Supplement OWL) – and it will soon be open to all dietary supplement companies, but where are things right now and why should companies...
Under the combined pressure of industry and lawmakers, the federal Drug Enforcement Administration has backed off its emergency listing of kratom to the schedule 1 list of controlled substances.
The federal Drug Enforcement Administration's plan to move kratom to the Schedule 1 list via an emergency filing has spurred significant pushback from industry stakeholders and from lawmakers. But even within the herbal sphere not everyone agrees...
The Food and Drug Administration has extended the comment period on the updated draft version of the New Dietary Ingredients guidance. The new deadline for comments is Dec. 12.
Sharing of best practices, knowledge of cutting edge analytical techniques, current market data, and positions from FDA and FTC on NDIs and claims substantiation will be tackled at an upcoming workshop hosted by the International Probiotics Association.
The botanical ingredients raw material GMP program started by GNC and managed by the American Herbal Products Association will be ready for final review in October, said an AHPA official.
