While the Farm Bill has removed industrial hemp from Schedule I of the Controlled Substances Act, the use of CBD as an ingredient has many more hurdles to overcome especially with the FDA, according to attorney Todd A. Harrison.
Puerto Rico has passed legislation that will allow supplement companies doing business there to sidestep legislation that the industry has objected to as burdensome and unnecessary.
Indian regulator FSSAI has issued a gazette notification of its amendments to the standards for children's supplements in the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011.
Whatever hemp proponents have been saying about the import of the 2018 Farm Bill, it is still illegal to market CBD containing dietary supplements in interstate commerce, FDA Commissioner Dr Scott Gottlieb, MD, reiterated yesterday. Dr Gottlieb said...
A proposal by an Arizona governmental branch to regulate supplements like drugs has been successfully opposed by the American Herbal Products Association and the Natural Products Association.
Counter to the chatter aroused by a recent report, the State of New York has not ‘banned’ CBD, according to an expert on the legality of hemp products. The state did however put some boundaries around a pilot agricultural program.
When Flow Alkaline Spring Water was looking to launch its next big idea in bottled water – a functional water infused with CBD (cannabidiol) and other botanical ingredients – it went to directly to the source: its four million US customers that the Canadian...
The European Medicines Agency (EMA) has said omega-3 fatty acid medicines are not effective in preventing further heart and blood vessels problems after heart attack – meaning medicines containing DHA and EPA for this purpose will no longer be authorised...
The latest iteration of the Farm Bill, which passed both house and senate and is headed to President Trump’s desk today, dropped a provision that would have allowed SNAP recipients to use their benefits to purchase multivitamin and mineral supplements.
An initiative unveiled by FDA Commissioner Dr Scott Gottlieb that could result in new legislation governing the dietary supplement industry was met with a spirit of cautious cooperation by stakeholders.
By Ellen Schutt, Executive Director, GOED (Global Organization for EPA & DHA Omega-3)
New science, developments in contaminant regulations, a new conversation around micro- and nanoplastics, and challenges on the regulatory front: In this guest article, Ellen Schutt, Executive Director of GOED, looks back on a very busy 2018 in the omega-3...
There is good news in the impending* Farm Bill for industrial hemp – which will be removed from Schedule I of the Controlled Substances Act - but this does not suddenly make the on-trend ingredient CBD (cannabidiol) legal in foods, beverages and supplements,...
The Codex Committee on Nutrition and Foods for Special Dietary Uses will continue to explore work on harmonized probiotic guidelines despite opposition from some delegations and industry trade associations.
The Codex Alimentarius Committee on Nutrition are to address the demands of regulating the global trade in nutrition products by developing a prioritisation process to address the excessive workload.
Canadian nutritional ingredient maker innoVactiv announced that Canada’s health authority approved beauty-from-within claims for its branded ceramide ingredient Myoceram.
The US Food and Drug Administration has warned consumers against kratom products because of heavy metal contamination. The announcement joins numerous warnings the agency has issued in recent years on the botanical.
The director general of New Zealand's Ministry of Health has issued yet another public warning about supplements containing Artemisia annua extract, after 11 more reports of liver complications from consuming such products surfaced.
The Federal Trade Commission has started to refund more than $750,000 to consumers who were duped into buying supplements marketed with spurious disease claims.
The Food and Drug Administration has issued a consumer warning over a line of male sexual enhancement products, citing a number of severe adverse health events suffered by consumers. The alleged marketer of the products has been arraigned on federal charges.
The sports nutrition category has undergone significant change in recent years, as many new non-core consumers are seeking out the products. This has coincided with increased regulatory scrutiny and calls for greater transparency, says the COO of ProSupps.
The kratom market has suffered another black eye with the release of a warning letter from FDA citing a marketer for material that was contaminated with salmonella. The letter also illustrates the ongoing regulatory ferment surrounding the botanical.
The prevalence of Bacillus cereus in infant and follow-up formula in China may warrant further research so criteria can be developed for risk assessment and quality control, say Chinese researchers.
By Dr. Kristy Appelhans, MS, NMD Senior Director, Global Consumer Safety, Herbalife Nutrition
Herbalife Nutrition, a world leader in dietary supplements, has developed a rigorous methodology for tracking the safety of its products in the many countries in which the company operates.
The US Food and Drug Administration (FDA) sent warning letters to two companies selling products marketed as ‘dietary supplements’ and labeled as containing tianeptine, which is being illegally claimed to treat opioid use disorder (OUD), pain, and anxiety.
From the 2018 midterm election results to the rise of CBD, Michael McGuffin, president of the American Herbal Products Association, talks about how the association is approaching the most recent changes in the supplements space.
By Elena Nekrasov, PhD, Senior Regulatory Scientist, Access Business Group, Amway
Getting your regulatory affairs department or a consultant involved early in the development process can save multiple headaches later when bringing new products to market. The global regulatory goalposts are moving all the time, and R&D teams need...
The Natural Products Association’s stance on CBD is to take FDA’s word on the controversial ingredient, until someone takes the front door with the Agency and files an NDI or a GRAS notification with the FDA for CBD.
Stuart Tomc, vice president of human nutrition for CBD purveyor CV Sciences, said his company welcomes increased scrutiny of the controversial ingredient category.
The low barriers to entry in the dietary supplement industry create the risk that the good deeds of the many will be besmirched by the transgressions of the few. Fortunately, there is something that can be done about it, given enough collective will.
The European Commission (EC) has given its seal of approval to Biova’s eggshell membrane for use in food supplements, representing the first approval of its kind for this ingredient.
FDA’s draft guidance on the labeling of products containing live microorganisms is a step in the right direction but does not go far enough, stakeholders say.
Four trade associations have sent out warnings to the public regarding ‘phenibut,’ which they say is a dangerous substance illegally posing as a dietary supplement.
“Just because we haven’t taken enforcement action people seem to think it [CBD] is OK,” said Steven Tave, director of the FDA’s Office of Dietary Supplement Programs, at a recent industry conference. “Anyone who thinks it is lawful is mistaken.”
Italy’s Ministry of Health has notified the European Commission (EC) of its intention to set maximum levels of THC (tetrahydrocannabinol) in food supplements.
Companies seeking to commercialise a probiotic product across the globe face a 'daunting task', which is why trade association the International Probitics Association (IPA) is vowing not to let up in its efforts to achieve a more consistent...
Internal alignment within a nutrition company is just as important as external collaboration, in order to ensure that the regulatory environment is as favourable and effective as possible.
A pregnancy supplement regimen offered by Gwyneth Paltrow’s lifestyle brand Goop is the subject of alleged multiple breaches to UK advertising and trading standards.
Amarin Corporation, maker of EPA drug Vascepa, has sued two omega-3s finished good manufacturers for unfair trade practices for allegedly using the results of the company’s large scale drug trial to market their own fish-oil based dietary supplements.
The Nagoya Protocol, the big changes coming for Lactobacillus classification, and how to boost your chances of success with an NDI notification were just some of the topic covered during the third annual IPA Workshop in DC.
The number of health-related microbiome projects has almost doubled in the last three years, with EU funding almost twice that of non-health related gut research.
The source of CBD should be of concern for the companies marketing the ingredient, said a legal expert at a recent dietary supplement industry event. But he also said the regulatory landscape for the ingredient is shifting so fast that any opinions he...
The FDA should consider whether a “significant liberalization of qualified health claim language would help drive innovation and be beneficial to consumers,” says Campbell Soup Co.
As the Supplement OWL approaches 12,000 labels in its Tier 1 product label library, the Council for Responsible has announced a new pilot program to build out Tier 2, which will be known as the Commercial Data Exchange, or CDX.
Making claims on products in the healthy aging sector is fraught with peril, as older adults, along with children, are seen as the most vulnerable populations, an expert says.
The European Commission (EC) intends to authorise for the first time a health claim arising from the combined effects of a number of substances, in a decision that affects firms backing the synergistic effect of nutrients in their products.
A paper that published this morning in the JAMA Network Open journal found that FDA had identified 776 adulterated dietary supplements in a 10-year period ending in 2016. As most of these products were tainted with drugs, calling them ‘supplements’ was...
The Botanical Adulterants Prevention Program has released a draft version of its standard operating procedure for the destruction of defective ingredients, which has been seen as a landmark in the dietary supplement industry’s self regulation efforts.
'Ignorance is amok... not even the investors are asking the right questions. It’s total anarchy'
If you ask the FDA or the DEA if CBD (cannabidiol) is permitted in foods, beverages and supplements, the answer is a pretty unequivocal NO. If you ask the scores of companies currently selling it in everything from CBD-infused soda to smoothie kits, the...
Whole food vitamin maker MegaFood has launched a petition drive aimed at banning the use of the pesticide glyphosate as a desiccant on crops before harvest.
Does DHSEA contain within it the seeds of the industry’s downfall? The freewheeling marketplace this regulation created has placed the barriers to entry so low that less than reputable companies have room to maneuver, creating risk for the whole industry.