A Livingston, MT resident has been sentenced to four months in prison and ordered to pay $80,000 in liquidated damages after pleading guilty to selling dietary supplements in violation of two court orders.
The FDA will have its work cut out when it comes to coming up with a workable definition of ‘natural’, if the comments submitted to the FDA thus far are anything to go by.
More stringent state or local-level laws could enhance regulation of dietary supplements, says a new academic paper that also compares the industry to Big Tobacco.
Beefing up supply chain management has been a mantra in dietary supplement industry meetings over recent months. For that to be most effective, it needs to include a consideration of supply partners’ business practices, experts say.
A concentrate of an old dietary ingredient may need to file a new dietary ingredient notification, according to a new warning letter from the US Food and Drug Administration about bitter orange.
How can you best show an anti inflammatory effect for a dietary supplement, and, having proved that, what can you say about that effect? Participants in a recent NutraIngredients-USA forum, now available on demand, tackled these and other questions.
The FDA has rejected a citizen’s petition calling for mandatory labeling of foods from genetically engineered crops, arguing that labels are not warranted unless there is a material difference in the safety or nutritional profile of the foods in question.
Delegates from the International Probiotics Association and the Brazilian regulatory authorities ANVISA will discuss the science and regulatory landscape for probiotics at an upcoming workshop.
The recent coordinated crackdown by federal regulators on the dietary supplement industry shined a harsh light on supply chain vulnerabilities. Finding the sort of fraudulent ingredients mentioned during Tuesday’s news conference is complicated by the...
The USPLabs case demonstrates the tools investigators and prosecutors can bring to bear when looking into the dealings of a dietary supplement company, a former prosecutor says.
Dietary supplement trade associations have universally welcomed the Department of Justice’s nationwide sweep targeting more than 100 makers and marketers of dietary supplements for alleged fraudulent ingredients and illegal claims.
The Department of Justice announced a criminal indictment of sports supplement maker USPLabs and several of its executives at a news conference in Washington, DC today as part of a nationwide sweep targeting more than 100 makers and marketers of dietary...
The Swedish Food Safety Authority (NFA) has urged consumers not to buy products containing DMBA – a novel substance used to replace the banned stimulant DMAA.
Senator Claire McCaskill has written to 10 retailers to ask them to voluntarily remove any dietary supplements containing picamilon, ‘after weeks of inaction by the Food and Drug Administration (FDA)’.
What is 'natural'? FDA finally weighs into the debate
Having studiously avoided this food labeling minefield for years, the Food and Drug Administration (FDA) has surprised many in the trade by seeking comments on the definition of a word that has launched a thousand class action lawsuits (well almost):...
GNC laid out a blueprint for the dietary supplement industry for a quality initiative including pre-market product registration at a meeting last week in Salt Lake City. The initiative builds upon GNC’s agreement with the NY AG office and is meant to...
Attention from State Attorneys General is expected to continue and even increase, with a recent meeting of the National Association of Attorneys General’s in St Louis hosting a public session on herbal supplements.
A warning letter issued last month to dietary supplement firm Sound Healing Arts illustrates what’s wrong with the current enforcement picture at FDA, says an industry observer.
The decision in the Bayer Corp. contempt case has important implications for the dietary supplement industry, say attorneys Steven Shapiro and Marc Ullman in this guest article:
Former FDA official Dr Joshua Sharfstein, MD, has proposed a new paradigm for the regulation of dietary supplements. The underlying shift would be a move from an attitude of “benefit versus risk” to one of “access with safety.”
The Board of the Council for Responsible Nutrition has adopted the proposal to move forward with a registry of dietary supplements, which could be a relatively quick process if an existing database can be ‘massaged’ to fit the criteria.
Food manufacturers remain sharply divided over FDA proposals to crack down on added sugar, with General Mills and other big names such as Kellogg and Unilever strongly opposed; and Nestlé, Mars, and KIND LLC in favor, according to the latest wave of comments...
The declaration from FDA on picamilon that formed part of the lawsuit filed by the Oregon Attorney General sets a troubling precedent, said Steve Mister of the Council for Responsible Nutrition.
The lawsuit filed by the Oregon Attorney General raises overall risk for the supplements industry and could mean that a number of niche ingredients could disappear from the market, experts said.
Experts from the Natural Products Association, Metagenics, Penn State University, and Greenberg Traurig LLP will discuss the opportunities and challenges of marketing products positioned for inflammation in the FREE-TO-ATTEND NutraIngredients-USA Inflammation...
The Oregon Attorney General has sued GNC over the sale of supplements that include picamilon and BMPEA. The announcement of the case caused GNC’s share price to plummet leading to a halt in trading.
Complying with the paperwork required by full GMP compliance has proved to be a headache for dietary supplement companies. Procedures automation firm Instant GMP can help.
Attorney Jason Sapsin shows how new FSMA rules apply directly to dietary ingredient firms that were exempted from GMP requirements that apply to supplement companies.
Two cases of drug spiking in products purporting to be dietary supplements drew enforcement actions announced recently by the Food and Drug Administration. One case in Puerto Rico involves sex enhancement products, while another in Pennsylvania dealt...
Proposals to introduce a mandatory pre-market registration of products with the FDA have received a lot of discussion in industry circles, but a voluntary system already exists and is functioning well, says Michael McGuffin, President of the American...
The US Food and Drug Administration is following up on recent findings that almost 40 products are still using DMAA, so are more warning letters expected?
Recent court cases may put the Federal Trade Commission’s penchant for requiring two trials to support health claims into the pending category. But that hasn’t blunted FTC’s increasingly detailed look at the design of the studies themselves, said lawyer...
The attacks on the dietary supplement industry orchestrated by New York Attorney General Eric Schneiderman have had beneficial effect, said American Botanical Council founder Mark Blumenthal. There is no denying the quality temperature is rising.
With about 50% of the industry's facilities inspected, GMP compliance is largely not where the FDA would want it to be, said the Agency's Dr Cara Welch.
Cara Welch, PhD, acting deputy director of the Division of Dietary Supplement Programs at the Food and Drug Administration, signaled a change in emphasis at the agency with a willingness to publicly acknowledge the dietary supplement industry’s GMP successes...
Senator Claire McCaskill, the ranking member of the US Senate Special Committee on Aging, has called for the FDA to suspend sales of supplements containing vinpocetine and picamilon pending an investigation.
Preliminary data from 2015 presented at a recent industry forum indicate that the Food and Drug Administration is issuing fewer 483s and the issues generating these observations during inspections are shifting from identity testing to specifications....
The Bayer vs FTC case in the US District Court of New Jersey is full of lessons, including what does and does not constitute ‘competent and reliable scientific evidence’, and the importance of having experts who know the space.
Dietary supplements containing picamilon are considered adulterated by the US Food and Drug Administration, because picamilon is not a legal dietary ingredient, the Agency has told NutraIngredients-USA.
The application of DNA barcoding to herbal supplements - which in the hands of the NY AG has been used as a bludgeon - could be turned into a significant boon for the industry, said United Natural Products Alliance president Loren Israelsen. The organization...
Customizable supplements may sound like a great idea, but the costs of complying with dietary supplement cGMP regulations would make such an endeavor ‘virtually insurmountable’, industry experts tell NutraIngredients-USA.
Illegal activity in the dietary supplements industry has become "a massive, and wide-ranging, consumer-protection problem", says the Department of Justice, which has put the issue high on the priority list within its consumer protection agenda,...
In an apparent widening of the NY AG affair, a state lawmaker in Massachusetts has introduced a bill to restrict the sale of weight loss and muscle building supplements because of the risk they are said to pose to vulnerable underage consumers, especially...
Europe’s peak sports nutrition trade group has affirmed broad support for better and more relevant sports food, drink and supplement regulation across Europe, but emphasised not all parties agree on how to get there.
Nailing down a precise nomenclature for herbs is a complicated undertaking, and the best good faith efforts of industry may have unwittingly given an opening to the NY AG Eric Schneiderman in his continuing offensive against the dietary supplement industry.
NY Attorney General Eric Schneiderman has sent cease and desist letters to 13 companies marketing devil’s claw supplements claiming the products fraudulently mixed one species of the botanical with a closely related species. Herbal experts, however, say...
Discussions continue within the industry whether some form of pre-market notification could be a valuable modification of existing dietary supplement regulations. But rifts are appearing over whether the implementation of such a system might unfairly...
By Steve Mister, President & CEO, Council for Responsible Nutrition
Once again the dietary supplement industry finds itself having to make tough decisions. Today the issue is pure powdered caffeine being sold directly to consumers. And the options are a lot more momentous than merely “would you like cream and sugar with...
While supporters of Rep. Mike Pompeo’s Safe and Accurate Food Labeling Act (HR1599) welcome its proposal to create a national standard for non-GMO claims, the Non-GMO Project says this would confuse shoppers by creating a competing label underpinned by...
