Regulation

Second big fine puts firms on notice to get serious about support for Made in USA claims

11-Oct-2021 By Hank Schultz

The Federal Trade Commission has handed down the another substantial penalty this year for a misleading Made in USA claim, underlining the risk such claims can pose to manufacturers if not properly constituted

FDA warns Arizona firm over numerous alleged disease claims

06-Oct-2021 By Hank Schultz

An Arizona supplement marketer has been warned by FDA over claims relating to blood sugar management, stress relief, immunity and more.

FDA issues 10 warning letters in enforcement action on diabetes treatment claims

13-Sep-2021 By Hank Schultz

The US Food and Drug Administration has issued warning letters to 10 companies making allegedly illegal diabetes treatment claims.

Another Blackstone Labs defendant pleads guilty

09-Sep-2021 By Hank Schultz

Another one of the defendants in the Blackstone Labs steroids enforcement action pleaded guilty in a Florida court recently.

NutraCast: SCNM launches graduate degree program ‘for the industry, by the industry’

03-Sep-2021 By Danielle Masterson

Despite being a multi-billion dollar industry, there are no graduate degree programs from accredited academic institutions for executives in the nutrition business sector—until now. The Southwest College of Naturopathic Medicine & Health Sciences...

FDA issues another warning in 10-year fight against sibutramine

30-Aug-2021 By Hank Schultz

The US Food and Drug Administration has sent another warning letter in its decade-long campaign against the use of the weight loss drug sibutramine in dietary supplements.

FDA lists NDI update among priorities for coming year

30-Jun-2021 By Hank Schultz

Publishing a revised version of the NDI Draft Guidance has made a list of FDA priorities for the coming year. Industry observers welcomed the news, but questioned how much impact it might have if enforcement priorities remain as they are.

Science must be specific to products, FTC reiterates In new raft of COVID-19 warning letters

03-May-2021 By Hank Schultz

The US Federal Trade Commission has cited another 30 companies or individuals for making what it characterizes as unsubstantiated COVID-19 treatment claims.

Supreme Court curbs FTC’s ability to levy fines

22-Apr-2021 By Hank Schultz

The Supreme Court ruled today that the Federal Trade Commission can no longer levy fines in the way it has been in recent years.

Trade associations bring pressure to bear against CA bill that would restrict sale of weight management products

20-Apr-2021 By Hank Schultz

A California bill to restrict the sale of weight management supplements has passed a key state legislative committee, increasing its chance eventually becoming law, trade associations have warned.

As a result of GRAS process FDA has no idea of what's on market, say paper's authors

08-Apr-2021 By Hank Schultz

A recent paper claims FDA is in the dark as to how many new ingredients have come onto the market via the GRAS process. Only limited progress has been made in the decade since a Congressional report first raised the issue and directed the Agency to make...

Joining the charge: Netherlands allows 'probiotic' labels

25-Mar-2021 By Nikki Hancocks

The Netherlands Food and Drug Administration has released guidance stating that the term 'probiotic' is allowed on food and supplement labels in the country, as mandatory information that characterises the product.

NPA, others support CA CBD bill while still advocating for federal solution

11-Mar-2021 By Hank Schultz

Yesterday the Natural Products Association testified in favor of a California bill to regulate the CBD trade in that state. NPA and others, however, have reiterated a call for federal legislation that would forestall the growing patchwork quilt of state...

Misguided CBD brands in last minute novel foods panic, ACI warns

01-Mar-2021 By Nikki Hancocks

Many UK CBD brands have been misled on how to prepare for the looming novel foods deadline meaning there is less than one month for some to pull together potentially impossible amounts of data, an industry expert has warned.

Another domino falls: EU countries to unite against probiotic labelling law

25-Feb-2021 By Nikki Hancocks

Denmark's Minister for Food, Agriculture and Fisheries has set out to work with Spain and other EU countries in an aim to change EU regulation to allow use of the word “probiotic” on labels.

USDA Final Hemp Rule draws mixed reactions from industry stakeholders

19-Jan-2021 By Danielle Masterson

The US Department of Agriculture (USDA) recently announced the final rule regulating the production of hemp in the United States — well over a year after publishing draft regulations.

Industry stakeholders look forward to working with Biden Administration even as pandemic, Kessler add cause for concern

18-Nov-2020 By Hank Schultz

Industry stakeholders anticipated a smooth working relationship with a new Biden Administration, but said this year’s highly unusual circumstances makes this transition more uncertain than most.

Warnings about cesium demonstrate difficulty of getting questionable ingredients off market

26-Oct-2020 By Hank Schultz

The US Food and Drug Administration has sent warning letters to five supplement companies about the sale of cesium chloride products, which the Agency said present significant health risks. The products have been a concern for several years.

Nutrify India expands market access, venture capital in international nutraceutical marketplaces

12-Oct-2020 By Danielle Masterson

Nutrify India, a nutra-consulting firm and ideas-to-commercialisation platform, is working on bridging the gap of connecting nutra innovators to large commercialization channels.

Pharmacists now being snared in COVID-19 disease claims net

21-Sep-2020 By Hank Schultz

FDA has now widened its Covid-19 warning letter net to include pharmacists as well as other health care providers and dietary supplement manufacturers and marketers.

CSPI urges FDA to do more to crack down on tianeptine sales

26-Aug-2020 By Hank Schultz

A nonprofit group has asked FDA to crack down on the sale of tianeptine, an ingredient that is sold as an antidepressant drug in many markets outside of the United States.

FDA moves to keep coronavirus fears from interrupting ingredients trade

25-Jun-2020 By Hank Schultz

The US Food and Drug Administration says it will move actively to prevent the worldwide trade in dietary ingredients, food ingredients and whole foods from being restricted because of misplaced coronavirus infection concerns.

‘Cynicism and disappointment’: Infant nutrition brands face credibility challenge after latest China scandal

27-May-2020 By Tingmin Koe

Both local Chinese and foreign infant nutrition brands in China are urged to “push hard on safety cues and messages” in light of the recent infant nutrition scandal happening in the country, according to an industry expert.

NutraCast Podcast: Patrick McCarthy on CBD research and regulation

17-Apr-2020 By Danielle Masterson

In recent months the FDA has been trying to figure out how to get the CBD market under control, with the focus on safety. Patrick McCarthy, CEO of Validcare, a cannabis sector-focused health and wellness research company, said the FDA is not going to...

Trade groups ask retailers not to stock products making coronavirus claims

07-Apr-2020 By Hank Schultz

A coalition of dietary supplement industry trade associations have come out in support of FDA actions against fraudulent coronavirus treatment claims and have urged retailers to not stock products with such claims on their labels.

From the editor's desk

Supplement industry can win with emphasis on safety, clapping lid on disease claims

03-Apr-2020 By Hank Schultz

The dietary supplement industry has an opportunity to communicate with a new range of consumers in light of the current crisis. Highlighting the excellent safety of the products and quality initiatives underway can help keep the embarrassment of rampant...

FDA sends warning letter to CBD firm over coronavirus claims

02-Apr-2020 By Hank Schultz

The US Food and Drug Administration has issued another warning letter on COVID-19 claims. This one was issued to a Nevada company marketing CBD products.

New supplement laws proposed to boost innovation and sector growth

20-Feb-2020 By Nikki Hancocks

The European Federation of Associations of Health Product Manufacturers (EHPM) has created a manifesto and regulatory proposal detailing significant legislative changes needed in order for the food supplements sector to reach its full potential to aid...

FDA suspends China inspections in light of COVID-19 outbreak

17-Feb-2020 By Hank Schultz

The United States Food and Drug Administration has suspended all inspections of facilities in China in keeping with a State Department travel advisory, the agency announced on Friday.

European board of experts agree on turmeric quality criteria

06-Feb-2020 By Nikki Hancocks

The Advisory Board on the Quality of Botanical Supplements has created a consensus paper to clarify how experts can examine the quality, safety and efficacy of turmeric supplements.

Guest article

Is Science For Sale? CRN expert reacts to recent attack on industry

30-Jan-2020 By Andrea Wong, Ph.D., senior vice president, scientific & regulatory affairs, Council for Responsible Nutrition

For those of us who have been in the health and wellness industry for a while, we know that the New Year predictably leads to lots of media coverage around health and wellness resolutions—new fitness regimes, eating patterns, and supplement use. And,...

Trust Transparency Center establishes new forum for single ingredient issues

28-Jan-2020 By Hank Schultz

Consulting firm Trust Transparency Center has announced a new initiative that the firm says will streamline the examination of single ingredient sourcing issues in the marketplace.

Views differ sharply on whether CBD legislation is best way to break logjam

17-Jan-2020 By Hank Schultz

Dietary supplement industry stakeholders are divided over whether proposed legislation to alter the regulatory definitions of dietary ingredients to specifically include CBD is the best way to break the logjam on the substance.

Stakeholders: FDA vacancies will hurt, but agency will weather storm

15-Jan-2020 By Hank Schultz

Industry stakeholders say that while critical vacancies at the US Food and Drug Administration come at an awkward time they believe the agency will fulfill its responsibilities.

Guest article

CBD, regulatory creep, and continued growth top AHPA's 2019 high points

18-Dec-2019 By Michael McGuffin, president, American Herbal Products Association

Questions surrounding the hemp/CBD trade, a recognition of the continued popularity of herbal supplements, and a casting a wary eye toward regulatory creep topped the list of 2019 concerns for the American Herbal Products Association.

FDA warns consumers about recalled products months after consent decree

17-Dec-2019 By Hank Schultz

A call from FDA to consumers to avoid products recalled as part of an enforcement action underscores how difficult it can be to get offending articles off the market.

Federal funding measure falls short on hemp/CBD, stakeholders say

17-Dec-2019 By Hank Schultz

An interim federal government funding measure does not include language creating a legal pathway for hemp/CBD products, despite advocacy on the part of stakeholders including lawmakers and trade organizations.

From the editor's desk

Wild ride over past decade shapes view of coming frenetic year

11-Dec-2019 By Hank Schultz

The dietary supplement industry is a crazy quilt that marries the sublime to the ridiculous and includes players of the highest moral and intellectual standards as well as those participating in the basest grubbing for money.

New York law sets stage for strictly regulated market for cannabinoids

11-Dec-2019 By Hank Schultz

New York State recently put into place regulations that govern hemp cultivation within its borders. In addition, the new law creates a regulatory framework specific to the trade in cannabinoid extracts and finished goods.

Appeals court decision, recent warning letters open door for more CBD suits

04-Dec-2019 By Hank Schultz

A recent appellate court decision coupled with a spate of warning letters sets the stage for more class action lawsuits like the proposed ones filed against CBD companies this week, experts say.

Trade group, state legislature turn up CBD pressure on FDA

22-Nov-2019 By Hank Schultz

Pressure continues to build to find a resolution to the CBD impasse. A trade organization and a state government have filed notices with FDA on the issue.

Editor's Spotlight

FDA needs new tools in face of CBD explosion, official says

08-Nov-2019 By Hank Schultz

FDA needs new tools to effectively deal with an expanding supplement marketplace, according to agency official Lowell Schiller. This is especially true when contemplating the flood of CBD products, with many more yet to come.

Contaminated CBD products could lead to anti-doping ban, ESSNA warns

08-Nov-2019 By Shane Starling

Athletes using cannabidiol (CBD) products should be prepared for a very real risk they could fail anti-doping tests due to contamination of banned tetrahydrocannabinol (THC), ESSNA has warned.

Welch returns to ODSP as deputy director

07-Nov-2019 By Hank Schultz

Cara Welch, PhD has been named deputy director of the Office of Dietary Supplements. Welch replaces Bob Durkin, who recently left FDA for a private law practice.

Existing amendments cover most of what ‘DSHEA 2.0’ would do, AHPA says

05-Nov-2019 By Hank Schultz

Before rushing into an amendment of DSHEA it’s wise to consider how the law has already been modified and how full enforcement of those provisions might accomplish what the modification advocates have in mind, a trade organization cautions.

BAPP’s adulterated materials SOP nearing final form

04-Nov-2019 By Hank Schultz

The Botanical Adulterants Prevention Program is nearing the final stage of its initiative to offer industry a way to keep adulterated materials from turning up in finished goods on the shelf.

Mississippi adds to regulatory tangle with warning on CBD products

28-Oct-2019 By Hank Schultz

Mississippi state officials have issued a blanket warning to consumers about the dangers of all CBD products sold in the state.

From the editor's desk

Is going big the only way to win in the supplement industry?

11-Oct-2019 By Hank Schultz

The inauguration of a huge, shiny, new (well, repurposed) facility leads to the question of what scale in the industry best serves the dietary supplement consumer.

Early data on FDA portal suggests FSMA is boosting safety

10-Oct-2019 By Hank Schultz

Early data on the Food Safety Modernization Act suggests the new law is working as compliance is improving and recalls have hit a five year low. A newly launched web portal will help track that data.

Labeling, colonization, adequate intakes, & taxonomy to be discussed at IPA’s DC Workshop

10-Oct-2019 By Stephen Daniells

The International Probiotics Association will host its fourth IPA DC Workshop with insights from a range of experts and stakeholders, including the FDA/ CFSAN, FTC, and Health Canada. The event is held in conjunction with the US Pharmacopeia.