The proponents of Washington State’s I-522 initiative mandating the labeling of foods containing GMO ingredients claim they have a slight lead hours before tomorrow's election deadline.
A letter from the office of Texas congressman Steve Stockman to the Food and Drug Administration urges the agency to better police the filing of New Dietary Ingredient notifications. The letter says that there are some ingredients in the market whose...
In order to foster development of the medical foods the Council for Responsible Nutrition has called on the Food and Drug Administration to revise its recently updated guidance on the issue to eliminate what it calls “extra-statutory criteria” that it...
GE Pharma, LLC has announced a recall of certain lots of its dietary supplement products Creafuse Powder Grape and Fruit Punch, which were found to contain DMAA (dimethylamylamine).
The Council for Responsible Nutrition has bolstered its science staff with the addition of Andrea Wong, PhD, who joins the organization in the role of vice president of scientific and regulatory affairs.
Tamika Cathey, a former FDA inspector and current independent regulatory consultant at EAS Consulting Group discusses identity verification regulations and methodologies. Cathey and 15 other industry experts will discuss botanical identity verification...
Personalized medicine—nutrition and health products customized to a consumer’s particular genetic profile—is no longer a trend for the future. According to the presenters at a recent conference, it’s happening now, and some giant companies have quietly...
The Food and Drug Administration is seeking a permanent injunction against James G. Cole Inc., an Oregon-based dietary supplement manufacturer. As is usually the case with such injunctions, the action is the culmination of a long interaction between...
A paper written by a group coordinated out of the University of Maryland proposes significant changes to the way probiotics are regulated, including using a monograph system similar to what regulators use in Canada to govern the use of the organisms.
A petition by American Herbal Products Association to the Food and Drug Administration on GMP inspections is an attempt to facilitate communication between the agency and industry, said AHPA president Michael McGuffin.
As a growing body of evidence indicates that iron and iodine play a crucial role in the cognitive development of children, though the presence of multiple other influencers, along with differences in need at various life stages present challenges when...
EPA-only ingredients and products are gaining traction in the supplements marketplace as more scientific evidence piles up for the ingredient as a standalone entity, independent of its source in oils that contain both EPA and DHA omega-3s.
GMP compliance has been a steep hill to climb for the dietary supplement industry by some accounts. And the advent of the regulations, which took full force for all sectors of industry in June of 2010, wasn’t good news for the nation’s forests as manufacturers...
Quality science, manufacturing and customer support have helped Ganeden Biotech achieve success with its proprietary staring of bacillus coagluans, branded as GanedenBC30, said vice president Mike Bush.
The news that NSF and two collaborators have found a methamphetamine-like compound in the popular pre-workout sports supplement Craze is being disputed by the product’s manufacturer, Driven Sports.
The US Food and Drug Administration (FDA) has sent a warning letter to Dallas, Texas-based USPLabs for its OxyElite Pro and VERSA-1 products, claiming the ingredient aegeline is not a lawful dietary ingredient, but the company says the ingredient is a...
A dietary supplement claiming to provoke remarkable speech gains in children has removed these claims from its website and is in the process of removing it from product packaging after the National Advertising Division of the Council of Better Business...
The sports nutrition market continues to expand, and with global demand rising, experts say opportunities are growing, too, for US made products in export markets.
In another high profile blow to the credibility of dietary supplements, the Children’s Hospital of Philadelphia has removed all but a few dietary supplements from its formulary, meaning parents of children in the hospital will have to sign a waiver in...
Acute non-viral hepatitis is tragic, whether it’s potentially linked to a product labeled as a dietary supplement or not. It is also tragic when critics of supplements use it as a stick to beat the entire industry with, despite there being many unanswered...
The Center for Food Safety and Applied Nutrition's (CFSAN) priority to publish guidance to help manufacturers with voluntarily GMO labeling could signal a change in thinking at the agency, says the United Natural Products Alliance (UNPA).
The Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition (CFSAN) has outlined its priorities for 2013-14, with a 'surprising' number relevant to supplements, including NDIs, GRAS, and GMOs.
The Dr Oz Show has been a boon for the natural products and dietary supplements industries. It has brought awareness to many less well-known ingredients, boosting usage and sales and, if the efficacy of the ingredients matches the claims, presumably positively...
The question whether an NDI notification opens the door for follow on ingredients has yet to be definitively answered. But sources say the question is a lot clearer when the putative follow on ingredient might not even be the same thing.
Dear colleague, With a vested interest in the viability of the industry, we believe that you want to be well informed, and it is in that spirit that we are writing to you today.
A dossier of scientific data that convinced Health Canada and Intertek Cantox of the safety of bitter orange extract, synephrine, has been sent to Finnish authorities which recently banned weight loss products containing the stimulant, along with caffeine.
The activities of the US Food and Drug Administration including routine inspections of facilities and the monitoring of imports have ceased following the government shutdown.
A recent lawsuit filed in California points out some of the issues concerning who’s responsible for product claims as a product makes it way to market. Everyone in the chain shares some of the burden for making sure claims are backed up, experts say.
The US Food and Drug Administration (FDA) has issued a warning letter to Oklahoma City-based Pure Energy Products, Inc. for products containing controversial compound DMAA.
The FDA says it will permit qualified health claims on the relationship between eating whole grains and a reduced risk of type 2 diabetes, but is the wording it has proposed so qualified that no food manufacturer will want to use it?
Metagenics, a prominent California-based dietary supplement manufacturer that specializes in medical foods and supplements sold through the practitioner channel, has received a warning letter in which FDA says a number of its medical foods are mislabeled...
A recent TV news segment on the subject of ginseng poaching raised the specter of the plant’s possible extinction in the United States. While that fear may be overblown, there’s little doubt that a number of factors (including overharvesting) are working...
Fat burning food supplements containing a combination of caffeine and synephrine are dangerous, according to Finnish authorities which have called for their removal from shelves.
Targeted Medical Pharma, a company that has specialized in medical foods, has announced the formation of a dietary supplement division to reach a new set of consumers, the company’s chief executive officer said.
The American Herbal Products Association has released a guidance for industry to help supplement manufacturers better understand how to comply with organic labeling requirements.
A new raft of warning letters for dietary supplement companies from the US Food and Drug Administration (FDA) shows that current Good Manufacturing Practice (cGMP) and label claims continue to cause problems for companies.
FDA may have opened a disease claims door for some dietary supplements when it shut another via its recently issued revised draft guidance on medical foods. That’s the contention of Peter Arhangelsky, an attorney with the law firm Emord & Associates.
The issue of caffeine in foods has gained momentum recently, with calls by political leaders to FDA to address what they consider to be a growing public health risk. A commentary posted yesterday by Michael R. Taylor, FDA's deputy commissioner for...
With two more warning letters sent by the US drug regulator to Indian companies for violation of acceptable manufacturing practices, America has brought to six the number of India-based drugmaking facilities against which it has taken action over the...
The UK medicines regulator has reinstated fat burning supplement, Dexaprine, after learning the Californian manufacturer had developed a special formulation for the UK market with medicinal ingredients removed.
A recent Food and Drug Administration warning letter issued to Australian snack foods manufacturer Waterwheel Premium Foods points out the fine line that separates acceptable label language from violation territory. The firm made numerous errors, in FDA’s...
Dutch authorities have issued a warning against a US fat burning food supplement called Dexaprine after 11 adverse reactions including hospitalisations and severe heart problems.
FDA’s recently updated draft guidance on medical foods specifically excluded diabetes as a condition for which a medical food can be formulated and marketed. As there are a number of such foods on the market, this change has been greeted with some consternation...
The Food and Drug Administration has given additional clarification to a ill-defined subcategory of foods by issuing a revised draft guidance on medical foods. The new version clarifies some issues surrounding branding and marketing, and in so doing,...
The second paper from researchers at Pew Health published this month to argue that the system governing the safety of food additives is deeply flawed, fails to provide any evidence that it has allowed harmful substances to ‘slip through the net’, say...
The FDA’s decision to give the thumbs up to spirulina as a source of blue color in candy and gum finally gives US firms a natural alternative to artificial FD&C Blue #1 ('brilliant blue') and opens up new opportunities in natural greens,...
A recent workshop sponsored by the Institute of Medicine on caffeine and its effect in consumer products such as energy drinks was helpful in making clear the points of view of the various stakeholders, according to observers. What was less clear was...
The Federal Trade Commission (FTC) has mailed 10,144 checks to reimburse consumers who bought Disney- or Marvel Hero-themed supplements for kids from NBTY and two subsidiaries under allegedly false pretenses.
