The FDA has written to three federal judges handling civil cases vs food manufacturers over natural claims to “respectfully decline” their request to come to an administrative determination of whether GMOs belong in ‘all-natural’ foods.
The US Federal Trade Commission’s new initiative to crack down on deceptive advertising practices for weight loss or management reinforces the importance of responsible marketing, say leading industry figures.
Dietary supplements, food additives, and skin creams are at the center of a new law enforcement initiative from the US Federal Trade Commission to stop national marketers that used deceptive advertising claims to peddle fad weight- loss products.
The US Food and Drug Administration (FDA) is working towards a method to validate the effectiveness and safety of medicated chewing gums such as nicotine gum.
The Food and Drug Administration has put industry on notice that it won’t tolerate the rising tide of dietary supplement ingredients being marketed for their role in ameliorating the effects of traumatic brain injury.
A warning letter from FDA to Star Scientific, makers of an antioxidant supplement called Anatabloc, underscores again the agency’s focus on the status of New Dietary Ingredients.
Reading through the warning letter tea leaves, Denver-based attorney Justin Prochnow has come up with some important themes from the Food and Drug Administration. Obligations of brand holders, status of liquid products and the regulatory status of new...
Checks totaling $5,936,243.63 are being mailed by an administrator working for the Federal Trade Commission to consumers who purchased acai berry supplements, “colon cleansers,” and other products from Phoenix-based Central Coast Nutraceuticals, Inc.
By Steve Mister, President & CEO, Council for Responsible Nutrition
These are confusing times to be a dietary supplement consumer – one day, a particular nutrient is touted as a magic bullet, and the next it’s a waste of money. In this constant news cycle we live in, consumers are left even more puzzled about what’s really...
By John Shaw, Executive Director and CEO, Natural Products Association
At the Natural Products Association, we are constantly working toward our mission of ensuring consumers have access to healthy products that will improve their well-being and longevity, and that the dedicated and passionate individuals who make and sell...
The Natural Products Foundation’s Truth in Advertising Program has hailed the responsiveness of companies to present accurate promotions and information about natural products to consumers.
Setting specifications for products and testing to make sure the lots going out the door meet those specs is a key facet of meeting GMP requirements. But if a company has a product that might include many ingredients, how does it formulate a realistic...
The Congressional Dietary Supplement Caucus in conjueciton with the leading dietary supplement industry associations held a briefing yesterday for members of Congress to drive home the point that supplements are not only good for users’ health, but good...
Personalized nutrition is one of the ultimate goals of the dietary supplement and functional foods business. But the FDA warning letter received by high profile genomics testing firm 23andMe is casting a cloud of doubt over the trend. If FDA views the...
The legislative office of China's State Council has been urged that its term “health-food product”, which refers to all dietary supplements, is too broad a concept and by definition can include “anything that is healthy for humans to consume”.
In a reflection of the broad nature of its membership, the American Herbal Products Association has submitted comments on two proposed Food Safety Modernization Act rules that run to nearly 200 pages. In part, the comments suggest ways to lessen the burden...
The Council for Responsible Nutrition has suggested additional clarification of the risk-based controls portion of the Food Safety Modernization Act. The suggested clarification, submitted by CRN to the Food and Drug Administration as part of the public...
Follow on ingredients that rely on the safety halo provided by New Dietary Ingredient notifications filed by competitors continues to be a serious problem in the marketplace, according to a prominent attorney.
While the FDA has raised concerns about the recent proliferation of caffeine-containing products on the market, particularly those marketed at young people, new data suggests energy drinks and shots contribute “minimally” to total caffeine intakes, say...
As dietary supplement firms prepare for their initial (or follow up) GMP compliance inspections, it pays to have the advice of a consultant and/or a lawyer up front. Fixing problems on the back end is inevitably more expensive, said attorney Ivan Wasserman.
Adverse event reporting, amphetamine-like substances showing up in products and NDI notifications are all prominent blips on FDA’s radar, said Loren Israelsen, president of the United Natural Products Alliance.
Dietary supplement use isn’t just about health; certain supplement regimens can be shown to deliver significant cost savings, said Steve Mister, president of the Council for Responsible Nutrition.
Knowing what identity tests to perform and knowing how to perform is more important than ever for botanical product manufacturers, said Roy Upton, executive director of the American Herbal Pharmacopoeia.
The United Natural Products Alliance is expanding in a focused state-by-state approach as a way to most effectively cultivate the next generation of legislative advocates who can take over in Washington, said UNPA president Loren Israelsen.
The FDA is preparing to finalize guidance clarifying the often hazy dividing line between liquid supplements and conventional beverages and foods as the debate over the proliferation of caffeine-containing products intensifies.
Hi-Tech Pharmaceuticals, the Georgia-based company from which FDA seized $2 million worth of products that contained DMAA, has sued the agency in federal court claiming the agency has bypassed standard rulemaking procedures in favor of a “bullying campaign”...
One year on and 'GMPs' and 'concern' continue to be used together by Dr Daniel Fabricant, Director of the Division of Dietary Supplement Programs at the agency, with many of the compliance issues still basic.
Cannabidiol, a non-narcotic fraction of cannabis, has been studied for a variety of health effects, from antioxidant properties to anti seizure effects. The health effects appear to be real, increasing the interest of some supplement formulators in the...
The recent massive recall of products containing enzymes contaminated with an antibiotic points out the need for companies to think out recall procedures in advance, experts say.
Finished product testing has been predicted to be a key focus for regulatory enforcement as FDA inspectors gain more experience and move beyond the first tier GMP compliance issues, but much of the industry is not yet ready for this increased scrutiny,...
The FDA moved to seize more than $2 million worth of DMAA-containing products from Georgia-based Hi-Tech Pharmaceuticals Inc. US Marshals seized the goods after agency investigators determined they contained 1, 3-Dimethylamylamine HCl (DMAA) or its chemical...
A major competitor has entered the astaxanthin ring with DSM’s launch of its new synthetic ingredient at the Supply Side West trade show in Las Vegas last week.
UPDATED -The campaign urging voters to say ‘YES’ to Washington State’s GMO labeling initiative 522 has acknowledged that it will not pass, but said the latest results show the tally was so close that had more young ‘progressive’ residents turned out to...
The US Food and Drug Administration (FDA) has issued a draft guidance for the food industry to help growers, manufacturers and operators work toward reducing levels of acrylamide in certain foods.
What will the legislative landscape look like for the dietary supplements and natural products industry look like after Senators Orrin Hatch, R-UT and Tom Harkin, D-IA retire? Trying to determine that in a positive way is one of the motivating principles...
The UK Food Standards Agency (FSA) has warned consumers off VERSA-1, the second pre-workout sports supplement made by Texas-based manufacturer USPLabs containing the disputed ingredient, aegeline.
Sports supplement manufacturer USPLabs has recalled lots of its OxyElite Pro products after receiving a letter directing the action from FDA motivated by reports of liver illnesses in Hawaii associated with the product. FDA also it directed the recall...
Ohio-based fish oil supplier Organic Technologies is expanding its distribution into Europe. But instead of trading on the “made in USA” angle that plays well for its AlaskOmega ingredients domestically and elsewhere in the world, the company plans to...
The Medicines and Healthcare products Regulatory Agency (MHRA) has joined the UK Food Standards Agency (FSA) in warning consumers off pre-workout sports supplement, OxyElite Pro.
I-522 is a victory for the proponents of GMO labeling, no matter how the final polls might turn out, attendees on a United Natural Products Alliance webinar were told yesterday.
With more than 85% of the votes in on Washington State's GMO labeling initiative 522 as of Thursday night, it appears that the Yes side has an insurmountable deficit to overcome, getting 47% of votes to the No side’s 53%. (Due to the state’s unique...
The botanicals industry was pleasantly surprised recently when the EU’s central science agency backed an isolated health claim for a bowel-benefitting herbal blend – but is EFSA really changing its botanicals approach before the EC has told it to?
The European Union botanicals sector has been in limbo since 2010 when 2078 botanical health claim applications were placed on hold as the European Commission bowed to pressure to reconsider the scientific criteria for their validation. With no end to...
With early results from Washington State’s ballot on GMO labeling (I-522) suggesting voters may narrowly reject it (click here) legal experts predict that while this particular battle may be lost, the war is far from over.
The incidence of liver damage caused on by herbal dietary supplements is on the rise, according to information presented at the annual meeting of the American Association for the Study of Liver Diseases. But those conclusions have been questioned by...
Initial returns indicate that voters in Washington State have given the thumbs down to GMO labeling proposal I-522, in similar proportions to the vote on California's GMO labeling proposal Prop 37.
The extent of adulteration of herbal supplements has been a question for as long as the products have been on the market. In light of damaging publicity, such as Monday’s article in The New York Times, is there evidence that progress is being made on...
Enzymes manufactured in India contaminated with an antibiotic have appeared in the US and Canadian markets after popping in Europe and Japan. The contamination could result in one of the biggest slews of product recalls in history.
LycoRed and EID Parry have agreed to settle a patent dispute over tomato lycopene products and manufacturing processes after 18 months of legal wrangling.
