If the Food and Drug Administration (FDA) does not revise its draft guidance on new dietary ingredients (NDIs) for supplements to reflect industry concerns, the trade might be stuck between a rock and a hard place, admit lawyers.
The limited nature of many toxicity studies into engineered nanoparticles used in the food and dietary supplements industry makes it very difficult to draw firm conclusions about their safety, according to one expert in the field.
A flurry of seizures, criminal charges, and warning letters shows that FDA is increasing it enforcement of dietary supplement regulations. Good for FDA and good for industry!
The US Food and Drug Administration (FDA) has issued a warning letter to Florida-based Cerebral Health, LLC, for failing to comply with Current Good Manufacturing Practice (CGMP).
The Natural Products Foundation (NPF) has called on regulators to take action against 13 dietary supplement firms making unauthorized disease and drug claims about dietary supplements.
The identification of a dangerous counterfeit product, designed to mimic the male sexual enhancement supplement ExtenZe, is further hard evidence of a growing trend, warns the Food and Drug Administration.
Senator Dick Durbin (D-IL) has asked the FDA to clarify its regulatory position on dietary supplements and food additives on the back of widespread concerns about the marketing of melatonin-containing baked goods.
There could be serious consequences for industry if the Food and Drug Administration (FDA) decides to start enforcing guidance clarifying the legal dividing line between liquid dietary supplements and conventional beverages, an expert has warned.
The Texas attorney general has obtained a temporary restraining order against a supplement company over supplement product packaging alleged to mimic an antibiotic.
Proposals by the FDA (Food and Drug Administration) to change how daily values on food labels are calculated are not in the interests of the dietary supplements industry or consumers, the Council for Responsible Nutrition (CRN) has warned.
Fears are mounting that the Food and Drug Administration’s (FDA’s) long-awaited guidance on new dietary ingredients (NDIs) could prove a “game changer” for the industry, and not in a good way.
The Standardized Information on Dietary Ingredients (SIDI) working group has encouraged FDA to exempt dietary supplements from import certification, as it responds to FDA on the Food Safety Modernization Act: Title III – A New Paradigm for Importers.
The congressmen behind last year’s abortive attempt to enable supplement makers to cite scientific studies on their labels and websites have launched a fresh bid to change the rules, but legal experts predict they face an uphill struggle.
Dietary supplement manufacturers operating in China will have to do more to guarantee the quality of their supply chains, after Chinese authorities imposed new quality control regulations last week.
The Food and Drug Administration (FDA) today issued a statement warning consumers to “beware of fraudulent dietary supplements” as its labelling, GMP and AER crackdown continues.
Last week the Food and Drug Administration (FDA) denied a petition that sought to have a synthetically manufactured algae extract called homotaurine classified as a new dietary ingredient (NDI).
The Food and Drug Administration has rejected Canadian biotech firm Ovos’s bid to win NDI status for its homotaurine brain health ingredient because the agency says the nutrient found in certain seaweeds is not an amino acid.
Makers of relaxation beverages could face problems in light of the FDA’s draft guidance on the distinction between dietary supplements and beverages, says New York-based food and drug attorney Marc Ullman.
NSF International’s acquisition of Connecticut-based contract laboratory Pharmalytica Services will allow the company to deliver of a wider range of health science services to the dietary supplements, biotech, pharmaceutical and medical device industries,...
In part four of this NutraIngredients heart health special we look at how regulators view those foods, drinks and supplements making cardiovascular claims
The enactment of the Dietary Supplements Health and Education Act of 1994 (DSHEA) was a ‘milestone in the development of Public Health policy in the United States’, says the editorial in a special issue of Fitoterapia.
Failing to follow manufacturing records, inappropriate batch production records and poor packaging and label control have been cited by the FDA in a recent post GMP inspection warning letter to a Montana manufacturer.
The FDA needs to provide better industry guidance on how to avoid making potentially misleading health claims on food labels, according to the Government Accountability Office (GAO).
As the Food and Drug Administration (FDA) prepares final guidance on Investigational New Drugs (INDs) a leading trade group has warned of the damaging effect on nutrient research that could follow if the application of INDs is not modified from the current...
Long Island-based dietary supplement firm, Hain North America has received a warning letter outlining infringements of Good Management Practice (GMP) from the Food and Drug Administration (FDA).
In the same week the US Food and Drug Administration (FDA) announced an industry-backed crackdown on spiked weight loss, body building and sexual enhancement products, the agency issued an alert against a sulfoaildenafil-contaminated product called Man...
The dietary supplements industry has backed the Food and Drug Administration in cracking down on products tainted with sibutramine, steroids and other substances.
Washington DC-based industry body the Alliance for Natural Health USA (ANH-USA) says the dietary supplements industry has been rewarded by the Food Safety Bill (S. 510), which could have included draconian measures to, “regulate away natural health”.
A herbal erectile dysfunction (ED) dietary supplement has been voluntary withdrawn from the US market by its Floridian manufacturer after it was alerted to a contamination problem with the unauthorized substance, sildenafil.
Following last Friday’s decision by Abbott Laboratories to pull its sibutramine-containing weight loss drug Meridia due to concerns about side effects, questions are being asked about dietary supplement contamination with the substance.
The legal counsel who represented Durk Pearson, Sandy Shaw and others in the recent case that forced the Food and Drug Administration (FDA) to alter three approved selenium health claims, says his clients and others will use the claims.
Advertising practices, substantiation standards and enforcement action for dietary supplements and functional beverages will be the focus of a seminar to be held later this week, which aims to help marketers ensure their strategies are successful.
Supplements maker iForce Nutrition has voluntary recalled its hormone supplement Reversitol after the Food and Drug Administration objected to the presence of an ingredient it deemed an unapproved drug.
A coffee product claiming to assist erectile dysfunction has been deemed an unapproved drug by the Food and Drug Administration (FDA) due to the presence of hydroxythiohomosildenafil, an analogue of sildenafil, used in the sexual aid Viagra.
In the fourth part of our special beauty from within series, we take a look at the regulations governing what you can say about nutriscosmetics products – which, in most jurisdictions, is not very much.
Industry continues to urge the Food and Drug Administration to close the Section 912 loophole in the Federal Food, Drug, and Cosmetic Act (FDCA) that could allow nutrients such as omega-3s, L-arginine and baobab to be reclassified as drugs.
The Food and Drug Administration’s failure to deliver a verdict on a citizen’s petition seeking to switch the status of a brain health ingredient from a drug to a dietary supplement is damaging the company behind it, and fueling ambiguity in the area.
The American Herbal Products Association (AHPA) says the Consumer Reports article that this week criticized the dietary supplements industry for being under-regulated and named a “dirty dozen” of supplement ingredients to avoid, is guilty of the kind...
The Food and Drug Administration is cracking down on what it describes as an “emerging trend” for dietary supplements to be spiked with prescription drug ingredients.
A dietary supplement trade group has urged the Consumer Product Safety Commission (CPSC) not to require adverse event reports from nutritional supplements in its incident reporting system as it will confuse consumers and interfere with existing processes.
The US Food and Drug Administration (FDA) has issued a warning to consumers that Magic Power Coffee – a dietary supplement marketed for sexual enhancement - is contaminated.
Montana-based TSI Health Sciences confirmed self-affirmed GRAS status for its chondroitin sulfate sodium offerings, as proposed regulatory changes increase demand for GRAS status for certain ingredients.
Council for Responsible Nutrition (CRN) chief Steve Mister will tell a Senate Special Committee on Aging meeting today that the dietary supplements industry is adequately regulated, but the FDA requires more funding to police it.
Five major dietary supplement trade associations have published Certificate of Analysis (CoA) guidance to help suppliers meet GMP requirements after several collaborating on the project.
The highly regarded good manufacturing practices (GMP) expert Carl Reynolds – recently re-hired by the FDA to help it manage GMP reporting – highlighted problems from stray rodent activity to lack of batch data to inappropriate identity testing.
No great changes in the working and general direction of the FDA Center for Food Safety and Applied Nutrition (CFSAN) are expected following the departure of the division’s director, Stephen F Sundlof, PhD, according to the Natural Products Association...
Federal inspections of food manufacturing facilities have declined over time, as have regulatory actions triggered by inspections, a government auditor reported on Wednesday.
After a host of positive moves over the past year, ChromaDex is optimistic about its future business, as it reported a 28 percent sales increase from $4.5m during fiscal 2008 to $5.7m in 2009.
By issuing warning letters to 17 companies including Nestle and Pom Wonderful, the Food and Drug Administration yesterday demonstrated it had both the motivation and the muscle to remove misleading nutrition and health claims from the market, a move industry...
Consumers are reading nutrition labels more often but are increasingly skeptical of front-of-pack health claims, such as ‘high fiber’ or ‘low fat’, according to a Food and Drug Administration (FDA) survey.
