Foreign food facilities run the risk of ending up on import alert if they don’t take note of a change in policy in a recent guidance from the US Food and Drug Administration.
Three members of Congress have sent a letter to the US Food and Drug Administration requesting specifics on how enforcement funds are allocated. The three lawmakers are among those the Council for Responsible Nutrition has worked closely with on regulatory...
'Live cultures are not all probiotic, although all probiotics are live cultures...'
US consumers are increasingly interested in the relationship between intestinal bacteria and overall health, says CHR Hansen, but there is some confusion about which foods and beverages contain probiotics: live microorganisms that, when administered in...
Dietary supplements took another hit in the mainstream press with an article in The New York Times that highlights supplements that claim to help treat opiod addiction. Trade organizations concurred the practice is illegal, while rueing the article’s...
A proposal by the International Probiotics Association to work towards harmonizing probiotic guidelines for use in foods and dietary supplements has received the support of Argentina, and the country will lead the work.
Dr Dan Fabricant, PhD, executive director of the Natural Products Association, has continued his forceful advocacy of existing compliant paths to market for CBDs in an appearance on The Doctors TV show.
The funding arm of the Council for Responsible Nutrition has renewed its support for the NAD dietary supplement advertising review program for an additional three years.
Products containing lithium orotate—a salt of a mineral that has been used to treat psychiatric disorders—have been the subject of two Health Canada warnings this year. Yet similar products are freely for sale south of the border, and don’t seem to be...
Will compiling an official list of Old Dietary Ingredients ultimately be worth the effort? Maybe, but the resulting list must be expansive rather than restrictive to be of much use, most stakeholders agree.
Amarin Pharmaceuticals Inc. has appealed the decision by the US International Trade Commission not to hear its case in which it had sought to prevent the import of some omega-3 dietary supplements. The company also filed a technical writ to try to force...
The US Patent and Trademark Office has granted a Notice of Allowance for the branded, sustained-release beta-alanine ingredient SR CarnoSyn by Natural Alternatives International.
A dietary supplement company that has received a previous warning letter from the Food and Drug Administration has agreed to a $3.7 million fine to settle a case brought by the Federal Trade Commission and the State of Maine for making over the top disease...
The US Food and Drug Administration (FDA) issued an alert to laboratories, health care providers, and the public, saying that consumption of biotin can “significantly interfere with certain lab tests.”
A new study conducted by anti doping researchers has found that products containing SARMs are readily available online and that many of the products contain additional undeclared, unapproved drugs.
The Natural Algae Astaxanthin Association has filed a citizen’s petition that seeks regulatory action by FDA against a synthetic form of astaxanthin marketed by Cardax.
Getting clever with product names can be an effective marketing strategy. It can also get a company in trouble with regulators, as a recent warning letter shows.
A recent warning letter to a dietary supplement company shows that FDA is starting to drill down to the next level of GMP compliance in looking at the scientific validity of tests used to verify ingredients.
Hailed by experts as ‘needed’ and ‘significant’, the US Food and Drug Administration has issued draft guidance on best practices to follow when convening a panel of experts to evaluate whether a substance is “generally recognized as safe” (GRAS).
The American Kratom Association has filed a formal demand for a retraction of FDA Commissioner Scott Gottlieb’s warning about the botanical. But an expert in adverse event reporting says new data available to FDA may mean the agency has evidence to support...
FDA commissioner Scott Gottlieb has warned about the ‘deadly risks’ associated with kratom and has said the agency “must use its authority to protect the public from addictive substances like kratom.”
Probiotics and prebiotics—the names themselves are a claim, something that companies need always to be aware of. This is one of the topics that will be covered in tomorrow’s Online Digest Health Conference sponsored by NutraIngredients-USA.
The need to verify one of its primary ingredients—aloe—has pushed Herbalife to become one of the industry’s leaders on identification and quality, an executive asserts.
The dietary supplement industry’s leading trade associations and the US Anti-Doping Agency have voiced their support of the recent FDA actions to protect consumers from body-building products containing Selective Androgen Receptor Modulators (SARMs) illegally...
The federal government has seized more than $3 million from Hi Tech Pharmaceuticals CEO Jared Wheat as part of its money laundering and mail fraud case against the executive and the dietary supplement company he controls.
The Natural Products Association has released a book compiling a list of pre-DSHEA (old) dietary ingredients to provide a “useful regulatory guidepost” for industry and regulators.
The state of prebiotic fibers remains in limbo while FDA mulls over comments to its guidance on the subject. But companies can still market their ingredients based on gut health benefits, experts say.
The Food and Drug Administration’s attitude that CBD does not belong in dietary supplements seems to have hardened, judging by the wording of four warning letters issued this week.
The Food and Drug Administration has issued a consumer warning against supplement-like body building products that contain SARMs, or selective androgen receptor modulators.
A recent injunction against a dietary supplement firm reinforces again the duty companies have to detect, declare and control for allergens. This responsibility will only accelerate with the implementation of FSMA rules, an expert said.
The FDA is proposing to revoke a health claim on the relationship between soy protein and reduced risk of heart disease, citing “inconsistent findings” from research published since the claim was authorized in 1999.
The US International Trade Commission has decided not to hear a case in which the fish oil drug maker Amarin sought to prevent the import of some omega-3 dietary supplements.
A dietary supplement manufacturer in Long Island, NY has been shut down by the Food and Drug Administration after numerous and repeated violations of GMP standards and labeling laws.
Partnerships with industry and other stakeholders are a key part of helping FDA keep up with a rapidly changing marketplace, FDA official Dr Stephen MD, attendees at a recent industry event.
A Massachusetts legislator’s attempt to restrict the sale of some dietary supplements seems doomed to fail in its latest iteration, but continued vigilance is needed, according to the head of the Natural Products Association.
An industry meeting next month may help dispel some of the uncertainty continues to swirl around the medical foods category, according to a speaker at CRN’s annual conference.
The International Trade Commission has requested an additional week to decide whether it will commence an investigation requested by pharmaceutical company Amarin concerning certain high concentrate omega-3 fish oil ingredients.
California-based supplement maker Custompax must stop selling products until it comes to compliance with the Food and Drug Administration (FDA)’s dietary supplement manufacturing regulations, according to a press release by the federal agency.
A combination of partially hydrolysed protein infant formula and specific prebiotic oligosaccharides leads to changes in the gut microbiota of infants at high risk of allergy, creating a microbiome that is closer to that of breastfed infants and which...
Industry GMP compliance presents a variegated picture with the biggest firms easily clearing the bar while smaller firms still struggle to make the grade, an FDA official said this week.
The legal troubles of Hi Tech Pharmaceutical CEO Jared Wheat continue to worsen with the unveiling of a judgement against him in federal court that has imposed sanctions of more than $40 million.
The US Food and Drug Administration has sent a letter to the International Trade Commission asking that agency not to hear a complaint in which the fish oil drug maker Amarin is seeking to prevent the import of some omega-3 dietary supplements.
Hi Tech Pharmaceuticals founder Jared Wheat has been charged with money laundering and wire fraud by federal authorities in an indictment unsealed last week.
Increasing scrutiny on the supply end of the dietary supplement business put the American Herbal Products Association in a position to contribute to the further legitimization of the dietary supplement industry, said the organization’s founder.
FDA’s undertaking to create a master list of ‘old dietary ingredients’ that could be sold legally in dietary supplements without first going through the new dietary ingredient notification process likely will fall flat, despite the agency’s best intentions,...
