The pace of Prop 65 suits in California continues to be brisk and settlement demands have been increasing, said a lawyer who represents dietary supplements in these actions.
According to UNPA president Loren Israelsen there has been plenty of recent innovation within the dietary supplement despite complaints to the contrary. But the NDI draft guidance could bring that to a screeching halt.
The Food and Drug Administration should include colony forming units or CFUs for probiotic labeling, says Amy Smith from DuPont, with a citizen’s petition a possible avenue for the change.
The dietary supplement industry has not shown steady improvement on GMP compliance. The same fundamental issues seem to crop up over and over, FDA official Cara Welch PhD said.
Under the combined pressure of industry and lawmakers, the federal Drug Enforcement Administration has backed off its emergency listing of kratom to the schedule 1 list of controlled substances.
The NDI draft guidance contains several points that are potentially issues for probiotics, and there appears to be a disconnect with the GRAS (generally recognized as safe) process, says a leading industry expert.
The NDI draft guidance offers a workable road map for companies willing to provide the safety information already called for by law, according to one ingredient supplier.
After years on the market, aloe as an ingredient is still poorly understood by most regulators around the world, attendees at a recent ingredient-specific session were told.
By Ivan Wasserman, counsel to the International Probiotics Association, and partner at Amin, Talati and Upadhye LLP
The United States Food and Drug Administration’s (FDA) regulation of products containing probiotics is complex and largely depends on the claims that are made for the product. For example, they can be regulated as foods, dietary supplements, cosmetics,...
The federal Drug Enforcement Administration's plan to move kratom to the Schedule 1 list via an emergency filing has spurred significant pushback from industry stakeholders and from lawmakers. But even within the herbal sphere not everyone agrees...
The Natural Products Association has called on the US Food and Drug Administration to extend the comment period on the status of vinpocetine until September 6, 2017.
The Food and Drug Administration has extended the comment period on the updated draft version of the New Dietary Ingredients guidance. The new deadline for comments is Dec. 12.
Health Canada is proposing to significantly change how natural health products and dietary supplements are regulated, with industry sources telling us the proposals are a concern.
An onerous administrative order in Puerto Rico has been pushed further onto the back burner, according to press reports and industry trade association communications.
In response to the recently re-released NDI draft guidance, the Natural Products Association (NPA) has said it is in the later stages of developing a comprehensive safe harbor list of pre-DSHEA dietary ingredients.
A recent FDA warning letter to a company selling noni products provides a quick précis for what not to do when trying to support your product with science, said an attorney who reviewed the communication.
More than half (56%) of dietary supplement professionals said they haven’t read the Aug. 11 NDI guidance—and 6% said they haven’t read it, but told their boss that they did.
From ingredient combinations to supercritical CO2 extraction to nanotechnology, here are some things to note from the new NDI draft guidance FDA released Aug. 11.
Over the last few years, the FDA has zeroed in on the dietary supplement industry. It has taken numerous actions against dietary supplements where it believes the ingredients pose health risks to the public. This scrutiny continues with the release...
Australia’s natural nutrition and complementary health industry has received a “once in a lifetime” boost after the government gave the green light to a raft of changes to how businesses will be regulated.
Wal-Mart Stores Inc. will remove the “Verified by an independent, certified laboratory” statement from its store-brand Spring Valley dietary supplement labels, following an agreement with Iowa’s Attorney General.
In what has been called an ‘unprecedented’ move, the Food and Drug Administration has initiated a proceeding to take vinpocetine off the market despite a number of successful NDI notifications filed on the ingredient.
The Drug Enforcement Administration has put mitragynine and 7-hydroxymitragynine, the active constituents of kratom, on its list of schedule 1 banned drugs, a list that includes heroin and LSD.
Advocates of supercritical CO2 extraction are dismayed that FDA singled this process out in its updated draft guidance on New Dietary Ingredients. This results from an overzealous adherence to the precise letter of the law rather than a focus on safety,...
The Federal Trade Commission has taken action against the publisher of a large number of what it calls ‘predatory’ scientific journals. The complaint alleges the publisher lies about the journals’ quality and influence, and charges undisclosed fees.
By Duffy MacKay, senior vice president, scientific and regulatory affairs, CRN
Duffy MacKay of CRN argues that there is much in FDA's newly released New Dietary Ingredients draft guidance that represents a step forward for the industry.
There is a thread of rhetoric in the supplement industry about being an ‘above board’ company. Twinlab CEO Naomi Whittel decided to take that notion to the next level by inviting Utah’s top law enforcement official for a visit.
New name would 'improve consumer understanding and promote clear food labeling' says Unilever
Unilever and The Center for Science in the Public Interest (CSPI) have both voiced their support for a citizen’s petition asking the FDA to permit ‘potassium salt’ as an alternate name for potassium chloride on food labels, while the Salt Institute has...
In addition to the areas that require clarification, the dietary supplement industry should look carefully and cautiously at the revised draft guidance for new dietary ingredient notifications, specifically at the economic impact of the FDA's new...
The devil is in the detail, and one detail easily missed in the new draft guidance for new dietary ingredient notifications is that self-affirmed GRAS is no longer mentioned as an ‘alternative’ to an NDI notification.
The new NDI draft guidance is very similar to the previous version, and yet the howls of outrage heard in 2011 are silent. What’s changed? Well, a lot…
Marketers of CBD-containing dietary supplements have long held out the hope that the status of hemp as a food in the US could provide some regulatory cover. A newly-released clarification by the Food and Drug Administration seems to cast further doubt...
The new draft guidance for new dietary ingredient notifications is “more positive than negative”, says Steve Mister, CEO of the Council for Responsible Nutrition.
New FDA rules clarifying the process by which ingredients are deemed generally recognized as safe (GRAS) have been welcomed by some stakeholders, but harshly criticized by others, who say any system allowing firms to self-determine the safety of their...
The updated New Dietary Ingredients draft guidance, issued yesterday by the Food and Drug Administration, modifies the agency’s stance on the contentious issue of synthetic, nature-identical compounds. But not by much.
Consulting firm Ingredient Identity has launched an outsourced quality assurance solution that could help smaller companies demonstrate better—and more cost effective—compliance in this important function.
Master Files and a grandfathered list are among the highlights in the FDA’s new Draft Guidance for New Dietary Ingredient Notifications, released this morning.
The Natural Products Association has stepped up its campaign at the national level to blunt the effects of an administrative order in Puerto Rico that puts additional burdens on dietary supplement companies operating there.
A recent warning letter issued by the Food and Drug Administration makes clear the danger marketers run into when using the words “inflammation” and “chronic” in the same breath, even in connection with an unusual product for that sort of claim, such...
US Marshals Service have seized over 100 cases of products labeled as containing kratom in California, the US Food and Drug Administration has announced.
New NGS DNA testing methods will replace PCR, predicts Clear Labs
As the Non-GMO Project states on its website, ‘GMO-free’ claims are “not legally or scientifically defensible due to limitations of testing methodology" coupled with cross-contamination risks. In future, however, that could change as testing methods...
The Natural Products Association (NPA) has announced the launch of its warning letter database, giving access to data on GMP violations, technical adulteration, and labeling infringements.
