The Food and Drug Administration has told a Texas start-up its melatonin-containing beverage breaches the Federal Food, Drug, and Cosmetic Act because the nutrient associated with promoting sleep is not approved as a food additive.
The US dietary supplements industry has launched a fight back against Senator McCain’s proposed Dietary Supplement Safety Act (DSSA), which they say poses an unnecessary threat to existing legislation.
The Food and Drug Administration has rejected suggestions that its enforcement action against companies which make false H1N1 claims for their health supplements relies too heavily on warning letters and fails to deter other companies from similar fraud.
The Food and Drug Administration’s recently issued draft guidance on the difference between liquid supplements and beverages is confusing and may create a slippery slope of inappropriate criteria and mis-categorized products, according to the Council...
Several American Herbal Products Association (AHPA) and American Botanical Council (ABC) members have been contacted by the Government Accountability Office (GAO) seeking information about the marketing of herbal products with an emphasis on new dietary...
Californian supplements giant, Herbalife, has plucked dietary supplements regulation expert, Vasilios (Bill) H. Frankos, MS, PhD, from the FDA’s Center for Food Safety and Applied Nutrition (CFSAN).
The Food and Drug Administration’s (FDA) apparent reluctance to take decisive action is failing to protect consumers against false H1N1 claims made for health supplements, claims a leading US lawyer.
The Food and Drug Administration’s commitment to greater transparency is bearing fruit in the dietary supplements area, with the availability of GMP 483 reports providing valuable insights into potential GMP pitfalls.
The FDA has told Ovos Natural Health it needs more time to process the Canadian biotech firm’s petition to have its brain health offering, homotaurine, accepted as a new dietary ingredient (NDI).
Pan-European better nutrition advocate, the Alliance for Natural Health (ANH), has merged with the American Association for Health Freedom (AAHF) to form the Alliance for Natural Health International.
A 1983 court case that distinguished between a drug and a food on the grounds of taste, aroma or nutritive value, is informing recently issued FDA advice on the difference between liquid beverages and dietary supplements, according to an industry figure.
The Center for Science in the Public Interest (CSPI) has proposed a makeover for nutrition labeling, including more emphasis on calories, added sugars, saturated and trans fats, and sodium.
Nutritional products maker Natrol has been certified by the Natural Products Association (NPA) Current Good Manufacturing Practices (cGMP) Certification Program.
The US dietary supplements industry should make itself the master of change not its victim, according to Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN).
New Jersey-based botanicals specialist, Sabinsa, has thrown its weight behind a citizen’s petition lodged by Canadian firm, Ovos Natural Health, that seeks to have its brain health ingredient recognized as dietary supplement ingredient after it initially...
A prominent member of the Cambridge Health Alliance and Harvard Medical School says DSHEA needs urgent reform because it is holding the FDA back from ensuring that dietary supplements are safe.
The FDA and DEA should exercise greater muscle in cracking down on products containing steroids and other contaminants, according to a Council for Responsible Nutrition (CRN) response to a Senate sub-committee on the topic.
A warning letter close-out process implemented this month by the US Food and Drug Administration (FDA) hopes to encourage firms to take corrective action – but so far even responses to warning letters are lacking.
The US FDA is being sued over its health claims regime – actions that are unlikely to succeed according to most pundits – but they raise serious questions about healthy food messaging and free speech that are being felt globally.
A notice detailing the new process for issuing warning letters to food companies that violate safety regulations has been published in the Federal Register, with the program due to begin on September 15.
The Food and Drug Administration (FDA) should expand its definition of economically motivated adulteration (EMA), says the American Herbal Products Association (AHPA).
A court action has been lodged today which challenges the Food and Drug Administration (FDA) qualified health claims system via five disputed selenium health claims.
A Canadian pharmaceutical firm is asking the US Food and Drug Administration (FDA) to approve a new supplement ingredient, which has demonstrated brain health benefits – one year after the firm withdrew its application for it to be approved as a drug.
The head of the US Anti-Doping Agency (USADA) has called for tighter regulation of sports supplements amid an investigation into steroid products allegedly being distributed to high school children.
Bogus weight loss products and cancer ‘cures’ have been amongst the top priorities of the US Federal Trade Commission (FTC) in its attempts to police product marketing, the Senate heard yesterday.
The US Food and Drug Administration (FDA) has clamped down on a number of dietary supplement firms that have repeatedly failed to meet new Good Manufacturing Practices.
The re-appointment of Michael Taylor in a senior position at the US Food and Drug Administration may not bode well for the supplements industry, according to one of the trade groups.
Georgia-based Hi-Tech Pharmaceuticals has issued a total recall of its “sexual stimulant” dietary supplement, after it was found to be contaminated with the banned substance, benzamidenafil.
The Food Safety Enhancement Act has been broadly welcomed by industry but a group of organizations has issued a letter to the relevant committee voicing strong opposition to several of the bill’s provisions.
With two weeks to go before mid-sized supplement firms need to comply with new GMPs, the US Food and Drug Administration (FDA) has said it aims to inspect 200 facilities this fiscal year.
A contentious proposal to compel US food manufacturers to contribute towards safety inspection costs took a step forward yesterday after the Food and Drug Administration signalled its backing for the idea.
The Council for Responsible Nutrition has given the thumbs up to only the second woman to hold the prestigious post of Food and Drug Administration Commissioner, Marageret Hamburg.
The recent Hydroxycut recall has caused a stir and the knives are out once again for the Dietary Supplement Health and Education Act (DSHEA). But food lawyers Ivan Wasserman and Svetlana Walker argue those that would carve the regulation up are turning...
The failure to diligently enforce the 1994 Dietary Supplements and Health Education Act (DSHEA) is the cause of most of the problems that have drawn a barrage of heavy criticism in the mainstream media, according to the Council for Responsible Nutrition...
The US dietary supplement industry is facing a massive media onslaught after recent recalls of harmful products have placed the sector and the law that regulates it under the spotlight.
On a summer’s day in 1906 Theodore Roosevelt pushed through new food safety regulation. The Food and Drugs Act passed that day over 100 years ago was the last time the US food safety system was modernized.
Lorraine Heller met with Randy Dennin, chairman of the Chinese branch of US trade group Natural Products Association (NPA), at Supply Side East and asked him about regulatory and other challenges on the Sino peninsula.
New York-based Maypro Industries is targeting a Japanese lychee extract at foods and drinks after it was self-affirmed GRAS (Generally Recognized As Safe) in the US.
Ingredient firm Cypress Systems has received FDA-reviewed GRAS status for its selenium yeast product, opening up the use of the ingredient in foods and beverages targeting a range of health conditions, including cancer risk reduction.
The US Food and Drug Administration (FDA) has again expanded its nationwide alert to consumers about weight loss products that contain undeclared – and often very harmful – pharmaceutical ingredients.
The second article in a series examining the impact of a new Congress on the functional food and supplements industries takes a close look at the new FDA Commissioner and Deputy Commissioner. According to industry veteran Loren Israelsen, we should expect...
The Food and Drug Administration (FDA) has been criticized for not enforcing Good Manufacturing Practises, but according to the FDA’s Brad Williams, boosted funding means FDA inspectors may be about to “saturate the field”. He spoke with Shane Starling...
New Jersey-based botanicals player, Sabinsa Coprporation, has published a paper in defense of its turmeric extract after the herb’s safety was questioned in an article published in the American Journal of Clinical Nutrition.
The US Food and Drug Administration (FDA) has warned the US public against a weight loss dietary supplement called Venom Hyperdrive 3.0 because it contains the banned pharmaceutical ingredient, sibutramine.
President Obama has said in a televised interview that his administration will conduct a complete review of the US Food and Drug Administration (FDA) to prevent future lapses in food safety.
The New York State Assembly is to amend its agriculture and markets law to require dietary and nutritional supplement manufacturers to label products as tested or untested by the Food and Drug Administration (FDA).
The US Food and Drug Administration (FDA) issued over 40 warning letters to supplement marketers last year. An analysis by FDA legal specialists Ivan Wasserman and Svetlana Walker reveals that the agency’s focus was on cancer claims made on internet web...
The use of nanotechnology in dietary supplements is badly understood and largely unregulated, and could be putting consumers at serious risk, claims a new report.
The general public should not be misled to believe that supplement products are dangerous or illegal by athletes’ uninformed usage of the products, and by irresponsible media coverage, according to a US supplements group.
