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).
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 FDA’s proposed changes for a phytosterol-based coronary heart disease (CHD)-lowering health claim should allow for powdered dietary supplements containing free phytosterols, says the Council for Responsible Nutrition (CRN).
The Food and Drug Administration (FDA) has issued a warning letter to a Connecticut-based manufacturer of vitamins, minerals and herbal extracts for a host of GMP breaches that include failure to test final batches.
The FDA has issued a warning letter to Florida-based dietary supplement manufacturer Abba Pharma over manufacturing, packaging and labeling violations.
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...
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...
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...
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.
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.
As genetic testing advances, and commercial tests increase in number, FDA oversight of the tests will strengthen, but it will remain a challenge to not stifle future innovation, says an academic from Duke University.
The Food and Drug Administration has revised three selenium, qualified health claims, after a court reiterated earlier rulings and ordered it to do so in July.
The Food and Drug Administration has told Unilever Americas that claims for a Lipton green tea product – mostly references to flavonoid studies on Lipton websites – amount to drug claims and must be amended or removed.
The Food and Drug Administration must follow a district court ruling and alter existing qualified health claims for selenium or face contempt of court charges, according to the plaintiffs in the case.
Small to medium enterprises (SMEs – less than 20 staff) were given two years longer to comply with GMPs than the biggest dietary supplements manufacturers, but it is feared many have yet to get their systems and documentation in order and would struggle...
The Food and Drug Administration has been ordered to amend qualified selenium health claims by a Washington DC district court that found FDA’s addition of lengthy disclaimers to the claims to be in breach of Constitutional, First Amendment, free speech...
Industry has responded positively to Wednesday’s Senate meeting on food supplements for the elderly, with its concerns about the need to increase FDA funding given a good hearing along with its affirmation of good practice as outlined in DSHEA.
The US food and supplements industry has taken a skeptical stance to a new report that recommends the same scientific approach is used to evaluate health claims on foods and supplements as on drugs and medical devices.
A Bill has been introduced to Congress backing the right of healthy foods and dietary supplements to cite scientific studies demonstrating health benefits.
An LA Times article drawing attention to FDA-approved labeling has stated that the FDA does not regulate, “vitamins, herbs or other dietary supplements”, and quoted an FDA official stating ‘health-promoting’ claims require no agency evaluation.
The parties suing the FDA over its qualified health claims system have filed opposition to the FDA’s own opposition to their suit that accuses the regulator of health claim censorship and distortion of scientific data.
In a world with a chronic ‘globesity’ problem spreading beyond western shores to places like India and China, products that promise to help individuals manage their weight via calorie control, fat burning, satiety, or some other mechanism, enjoy rampant...
In 2008, the Food and Drug Administration (FDA) issued 44 warning letters with internet cancer claims being the primary target. In 2009, the agency upped the ante, issuing 73 letters, half of which targeted swine flu (H1N1) products. Washington DC-based...
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.
Each day the US Food and Drug Administration (FDA) dithers in delivering its verdict on the safety of bisphenol A (BPA), its authority is diminished and its credibility wanes.
There are serious flaws in a US Government system to help federal agencies pinpoint plants implicated in outbreaks of food-borne illnesses, according to new report.
Insufficient inspection numbers, unclear ingredient identity testing and supplier audit requirements to meet Good Manufacturing Processes (GMPs), are some of the problems blighting the recently introduced regulation, says a Californian-based supplier.
The difference between liquid dietary supplements and beverages bearing novel ingredients is the subject of new guidance from the FDA, which has become concerned about practices occurring in the area.
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...
The legal firm behind two actions that challenge the US qualified health claims system has asked a District of Columbia District Court to issue a summary judgment against the FDA over its selenium claims.
The FDA has withdrawn a warning letter published on its website and issued to two Procter and Gamble vitamin C-fortified dietary supplement/drug combination products.
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 market-leading weight loss supplement Hydroxycut has been reformulated and re-launched in the United States, just months after being recalled for potentially causing liver damage.
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.
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.
New FDA guidance to dietary supplements marketers on the reporting of adverse events has been welcomed by industry as being a “helpful” and “useful” resource.
Enforcement action by the US Food and Drug Administration (FDA) is a key area where more open communication with industry is necessary, the agency will hear today during a public meeting on transparency.
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...
Consumers who choose foods labeled ‘zero trans fats’ could still surpass their recommended daily limit due to FDA rules that allow up to 0.49g of trans fat per serving to be rounded to zero, says spread company Smart Balance.
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.
General Mills has been told to change the marketing of its popular Cheerios whole grain cereal, as the health claims it currently uses classify it as an unapproved drug.
Dr Margaret Hamburg, the Obama Administration’s pick to lead the FDA, easily cleared the Senate on Thursday, while the Administration proposed a record budget increase for the agency.
The recent recall of top-selling Hydroxycut weight loss products has prompted the – not unexpected – call for a review of regulations governing dietary supplements in the United States.
The Food and Drug Administration (FDA) has taken another blow as a US news organization published figures on Thursday showing it is failing to meet its goals for auditing individual states’ food safety inspections.
The US Food and Drug Administration (FDA) has initiated a massive recall of a top-selling American weight loss supplement brand, after a series of adverse event reports indicated that the products could be linked to serious liver damage.
Although all medium-sized dietary supplement manufacturers in the US will be required to meet new GMP regulations as of June this year, FDA has said it is unlikely to start inspections until fall. The agency’s manager of the Division of Dietary Supplements...
Today is the first day of Supply Side East, one of the major east coast trade shows for the functional foods and supplements industries. Lorraine Heller takes a peek at the program and shares some thoughts about what to expect from the show.
Functional foods in the US are not legally defined as a distinct category, which has generated a confusing regulatory framework. In this article, NutraIngredients-USA.com provides a break-down of the health claims that can be used on the products.
