In part four of this NutraIngredients heart health special we look at how regulators view those foods, drinks and supplements making cardiovascular claims
A Warning Letter from FDA telling the recipient to also respond to the FTC may indicate a ‘blurring of the lines between the two agencies’ laws and jurisdictions,’ says a FDA legal specialist.
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.
The National Advertising Division (NAD) of the Council of Better Business Bureaus has backed brain claims for a dietary supplement based on studies focused on Alzheimer’s disease.
“You gotta do what you gotta do,” an exhausted Cathy Keys told NutraIngredients-USA today after spending the best part of two months completely renovating her family-run online supplements business, NutriHerb.net, after receiving an FDA warning letter...
A consumer class action lawsuit has been filed against Ferrero USA in a San Diego federal court, accusing it of falsely portraying Nutella chocolate hazelnut spread as part of a nutritious breakfast for children.
The Federal Trade Commission (FTC) is likely to aggressively pursue immunity claims being made by Coca-Cola Vitaminwater after it was called on to investigate them by the Washington DC-based National Consumers League (NCL) this week, a food law attorney...
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.
California supplement manufacturer Irwin Naturals has agreed to pay $2.65 million over alleged misleading advertisements and a failure to label lead is in its products.
The Food and Drug Administration has affirmed the principal that references to scientific studies can amount to drug claims under the Federal Food, Drug, and Cosmetic Act (FDCA).
In the second part of this special series on global outsourcing trends NutraIngredients explores how the European Union nutrition and health claims regulation (NHCR) is impacting activity in the contract research organisation (CRO) sector.
A vitamin D qualified health claim will soon be submitted to the Food and Drug Administration even as concerns grow about the recent vitamin D scientific update issued by the Institute of Medicine (IOM).
2010 saw the first warning letters from the US Food and Drug Administration (FDA) for supplement Good Manufacturing Practices (GMP) violations, but the overall numbers were down on 2009 levels. FDA legal specialists Ivan Wasserman and La Toya Sutton look...
The complacency being exhibited by Brussels over the ongoing dioxin contamination incident is every bit as concerning as the carcinogenic chemical that has found its way into the food and feed chains since the end of last year.
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).
Californian-based pomegranate juice leader POM Wonderful has filed a motion in a Washington DC District Court urging a ruling on its September action against Federal Trade Commission (FTC) claims policing policies.
Industry is calling on the FDA to extend the compliance period to proposed changes the agency is making for a phytosterol-based coronary heart disease (CHD)-lowering health claim that will broaden it beyond esterified forms to include free sterol and...
The Kellogg Company will pay $5m to consumers misled by children’s immunity claims for its Rice Krispies breakfast cereal, after agreeing terms in an amalgamated class action in a California court.
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...
Freshly issued FDA GMP guidance for small-to-medium sized dietary supplement manufacturers regurgitates a lot of what has already been published in the regulation, but does bring fresh focus to matters such as expiration dates and ingredient supplier...
Raising awareness about natural foods and dietary supplements is the aim of the National Products Association’s (NPA) new educational campaign focused on the 100 plus new members of the US Congress.
About 400,000 cartons of alcoholic energy drinks have been destroyed as part of an ongoing Food and Drug Administration crack-down on the controversial beverages.
Italian supplier Gnosis Bioresearch has won New Dietary Ingredient (NDI) approval from the Food and Drug Administration for a synthetic folate salt form.
Natural Supplement supplier Drive Total Energy is voluntarily recalling its Passion Coffee Dietary sachets and Rock Hard Extreme capsules after the Food and Drug Administration (FDA) discovered undeclared drugs in the products.
Consumers have been warned by the Food and Drug Administration (FDA) not to consume Fruta Planta weight loss products after they were found to be contaminated with the dangerous chemical sibutramine.
2010 saw a flurry of enforcement activity by the Federal Trade Commission (FTC) based on claims made for dietary supplement and functional food products. There is no indication that 2011 will be any different.
Industry groups have welcomed the passage of the Food Safety Bill, highlighting lobbying efforts and Congressional support that kept potential burdens out of the amended legislation.
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).
2010 has been another tough year for the European functional food and supplements industries as health claim rejections have continued to flood in, leaving some in a state of high anxiety, fear and dread. Others are just mildly annoyed at a situation...
Global pomegranate juice leader POM Wonderful has spent a large part of 2010 locking horns with the Federal Trade Commission over health claims for its juices and dietary supplements.
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...
Dannon says its year-long negotiations with the Federal Trade Commission that resulted in a $21m settlement and modifications placed on its health statements, has not altered the core claims for its multi-million dollar selling probiotic yoghurts.
The dietary supplements industry has backed the Food and Drug Administration in cracking down on products tainted with sibutramine, steroids and other substances.
NBTY has settled with the Federal Trade Commission (FTC) over DHA-based brain and eye children’s health claims it has been making for some its Disney-branded dietary supplements.
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”.
The Food and Drug Administration (FDA) is proposing to expand the variety of foods enriched with phytosterols that can carry a health claim linking the ingredients to a reduced risk of coronary heart disease (CHD).
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.
Should the FDA work to be more like EFSA? Speaking at the NutraIngredients Health Claims 2010 conference Andrew Shao said the two organisations are already very similar in the way they review scientific claims.
When several fish oil suppliers were sued in a Californian court over contamination issues at the beginning of 2010 many feared the worst for the sector, but Ocean Nutrition Canada chairman Robert Orr explains why the soon-to-be-settled case has yielded...
The Federal Trade Commission (FTC) says it has not set any new claim substantiation “rules” in a new court action against California-based pomegranate player, POM Wonderful.
The hand on the tiller that is food safety in Europe has been left somewhat unsteady by the recent regulatory actions taken by the European Commission on BPA and food colours – moves that are pandering to consumer fear and showing contempt for the food...
A former Health Canada official has criticized the agency for failing to publish health claim-backing data, after recently approving an oat fiber-cholesterol health claim.
The Kellogg Company will pay consumers up to $2.75m over misleading kids’ attention claims for its Frosted Mini-Wheats cereals, after a federal judge reached a class action settlement.
The Food Directorate of Health Canada has concluded that Kemin Health’s Slendesta potato extract may now be marketed as a non-novel food ingredient, allowing formulation into a range of foods and beverages.
Health Canada and Food and Consumer Products of Canada (FCPC) have launched a Nutrition Facts Education Campaign, focusing on improving consumer comprehension of % Daily Value amounts.
