The Council for Responsible Nutrition (CRN) is calling on the FDA to step up to the plate and carry out the inspections necessary to ensure GMP rules are followed.
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...
Michael McGuffin, the president of the American Herbal Products Association (AHPA), tells Shane Starling why recently implemented adverse event reporting (AER) is delivering on its promise some three years down the line.
Eggshell ingredient firm ESM Technologies says that recent independent tests on its calcium ingredient have verified that heavy metal levels are well below legal limits, which the firm hopes will boost its uptake as a natural source of calcium.
A new guidance manual targeting the US dietary supplement industry aims to help firms document their manufacturing processes to ensure they meet Food and Drug Administration requirements.
Federal inspections of food manufacturing facilities have declined over time, as have regulatory actions triggered by inspections, a government auditor reported on Wednesday.
Private equity firms came in droves to Expo West looking for post-recession bargains, with dietary supplements firm in their sights. A NutraIngredients-USA.com straw poll in the supplements aisles confirmed acquisition offers were as abundant as natural...
The Major League Players Association has added 21 products to its ‘Dangerous Contaminated Supplements’ list to bring the total number of blacklisted products to 104.
John Gay, the executive director and CEO of the Washington DC-based Natural Product Association (NPA), commends industry for the lobbying effort that has led to Republican Senator John McCain agreeing to alter his highly unpopular Bill.
In this US regulatory round-up, New York-based food and drug attorney, Marc Ullman unpicks the reformed position of Republican Senator John McCain on the regulations governing dietary supplements.
Arizona Republican Senator, John McCain, has indicated he may withdraw support for the Bill he sponsored in February that would have severely amended the way the US dietary supplements industry is regulated.
Texan omega-3 supplier Omega Protein Corporation says its offerings meet international regulatory requirements, including the strict contaminants rules set out in California’s Proposition 65.
Groups representing fish oil suppliers have defended the safety record of the multi-billion dollar omega-3 source in the face of legal action mounted in a San Francisco court.
Food manufacturers aspiring to ethically sound practices should seek ingredient quality assurance, says US Pharmacopeia, the standards-setting authority behind the Food Chemicals Codex (FCC).
Republican Senator John McCain of Arizona has issued a statement criticizing “lobbyists” of falsely attacking the Dietary Supplement Safety Act of 2010 he introduced at the beginning of the month, which seeks to amend DSHEA in several fundamental ways.
A small study published in the American Journal of Gastroenterology has confirmed links between the herbal weight loss supplement Hydroxycut, and liver problems.
National public health association Health Canada has backed a report which recommends closer monitoring of adverse reactions to Herbal Medicinal Products (HMP).
“The time has come for lawmakers to re-evaluate the DSHEA,” is the conclusion of a Johns Hopkins University School of Medicine academic in a recent report published in the Archives of Internal Medicine.
Industry groups and legal experts have condemned the Dietary Supplement Safety Act of 2010 as an unnecessary threat to existing legislation that is already empowered to ensure dietary supplements in the United States are safe.
Australia’s Therapeutic Goods Administration (TGA) is reviewing the status of the weight loss product, Hydroxycut, which has been linked to liver problems.
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...
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...
Health Canada is “monitoring the situation” after four of six black cohosh supplement products were found to contain related herbs, but not black cohosh itself.
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.
In the fifth and final installment of this DSHEA special, Frank Jaksch, the president and chief executive officer of Californian-based botanicals reference provider, Chromadex, outlines why he thinks current GMP inspection methodologies are unlikely to...
In part two of this DSHEA special, Mark Blumenthal, founder and executive director of the American Botanical Council, outlines why he believes DSHEA is a victim of the “erroneous negative view” that it limits the power of the FDA and can’t control rogue...
Enforced consumption of folic acid introduces adverse health risks to a wider population and flour millers and bakers may be legally liable for health claims resulting from mandatory folic acid fortification, claims one of the leaders of the Australian...
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.
CRN’s annual symposium has heard how the industry needs to better fight its corner when faced with the threat of product contamination, but was benefitting from challenging economic times.
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.
Senator Arlen Specter put forward the idea of premarket government approval for dietary supplements at a senate hearing yesterday on hidden steroids in body building products.
Supplement industry stalwarts and critics are preparing to trade blows today at a senate committee hearing on hidden steroids in body building products.
Dietary supplements are again the focus of attention in recent articles published in The Wall Street Journal and New York Times – and once more the products are portrayed in a less than flattering light.
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.
The United States Pharmacopeia (USP) is calling for more stringent testing methods and definitions to combat the growing problem of economically motivated adulteration (EMA) of dietary supplements.
Dietary supplement trade groups have said they will ensure their members meet new labeling requirements to include a full address or telephone number, but have suggested that they are under no legal obligation to add any other ‘signal language’ to their...
The US Food and Drug Administration has again updated its guidance for the labeling of dietary supplements, and continues to ‘recommend’ the inclusion of manufacturer contact details for adverse event reporting.
A group of zeaxanthin suppliers have united to form the Zeaxanthin Trade Association to increase global awareness of the eye health nutrient and adopt quality standards.
Missouri-based National Enzyme Company (NEC) has passed an extensive Good Manufacturing Practices audit of its Australian operations by the regulator there and can continue to market its ingredients and dietary supplements.
A consumer health bulletin sent out this month by the Mayo Clinic warns Americans of possible health risks related to the use of herbal dietary supplements.
A US District Court has ruled against the Federal Trade Commission (FTC) and in favor of a supplements firm, in a landmark case that found FTC’s criticism of the company’s advertising was simply a “difference of opinion”.
The Food and Drug Administration is being sued over its controversial and much-amended GMP regulations on the grounds the 1000-page rule is “ambiguous where it should be clear”, according to the attorney mounting the action.
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.
It looks like the FDA has finally got some muscle. Never mind new legislation – if anything can prevent America acquiring a weedy reputation for food safety, it’s the might of Dr Margaret Hamburg.
The Food and Drug Administration (FDA) should expand its definition of economically motivated adulteration (EMA), says the American Herbal Products Association (AHPA).
