Regulations

Expert opinion

ESSNA insights: CBD developments for the sports nutrition industry

16-Feb-2023 By Nikki Hancocks

The number of sports and active nutrition companies investing in CBD has grown significantly in Europe over the last few years despite regulatory uncertainty, so what does this market hold for these brands? In this article, ESSNA’s Chair Dr Adam Carey,...

Brands gear up to work with Congress on CBD pathway

06-Feb-2023 By Danielle Masterson

As CBD rulemaking languishes, businesses experience frustration and uncertainty.

House Oversight chair to FDA: Enough is enough

17-Jan-2023 By Danielle Masterson

FDA’s failure to act on CBD created a space for bad actors and poor products to thrive, now the chairman—and the industry—want answers.

FTC seeks injunction against marketer of vitamin/mineral supplement

05-Dec-2022 By Hank Schultz

The Federal Trade Commission has filed a request for a permanent injunction against a dietary supplement marketer that allegedly made repeated claims to treat COVID-19 via a vitamin/mineral product.

Letter from US Representatives asks that supplement provisions be dropped from fees bill

12-Aug-2022 By Hank Schultz

A bipartisan group of US Representatives have sent a letter to House leadership requesting that the dietary supplement provisions be removed from a bill reauthorizing FDA user fees.

CRN: Few firms will file NDIs under current guidance

21-Jul-2022 By Hank Schultz

The Council for Responsible Nutrition said that persistent problems with FDA’s NDI Draft Guidance means that few firms likely will file new notifications during the recently announced amnesty window.

Industry stakeholders spar over whether pushing for MPL has been tactical error

16-Jun-2022 By Hank Schultz

Mandatory Product Listing can still be a good idea for industry, proponents maintain, even if the latest legislative iteration has failed to garner support from stakeholders.

Trade organizations line up against bill that includes new supplement regulations

15-Jun-2022 By Hank Schultz

Three trade organizations joined forces in opposing the FDA Safety and Landmark Advancement Act of 2022 (FDASLA), a fee authorization bill that includes provisions aimed at tightening dietary supplement regulations.

Enforcement discretion gives some solace to NAC space, observers say

29-Apr-2022 By Hank Schultz

FDA’s recently announced enforcement discretion policy on NAC will bring some certainty to the market. But it doesn’t answer all of the questions surrounding the ingredient, which could cause other issues later, experts said.

Federal program may suspend exports of fish oil supplements, GOED warns

27-Apr-2022 By Hank Schultz

A fast developing regulatory issue has the potential to throw a wrench into the works of the fish oil supplement trade, a trade group has revealed.

Supplement closet skeleton grapefruit seed extract makes appearance in warning letter

08-Feb-2022 By Hank Schultz

Grapefruit seed extract, a dubious ingredient that seems to have more lives than a cat, has made another official appearance, this time in a warning letter from the US Food and Drug Administration.

NEWS IN BRIEF

FDA resumes domestic inspections as Omicron wave subsides

07-Feb-2022 By Hank Schultz

A decline in COVID-19 cases nationwide has led the US Food and Drug Administration to resume domestic surveillance inspections across the country.

CHPA debuts consumer resource for understanding supplement labels

20-Jan-2022 By Hank Schultz

The Consumer Healthcare Products Association has made available an online informational tool for consumers that will help them decipher the Supplement Facts panels on product labels. It’s part of CHPA’s move to raise its profile in the dietary supplements...

CRN says FDA dodging central legal issue in its stance on NAC

06-Jan-2022 By Hank Schultz

The Council for Responsible Nutrition has turned up the heat on FDA over its position that NAC is not a legal dietary ingredient. CRN asserts that the Agency has ignored a central legal question.

Warning letter signals return of on the ground inspection observations for 2022

04-Jan-2022 By Hank Schultz

A warning letter sent to a dietary supplement manufacturer signals a return of enforcement actions based on on-site inspections, which had been suspended for a time during the global pandemic.

Guest article

AHPA celebrates regulatory victories during year that tested industry's resilience

20-Dec-2021 By By Michael McGuffin, President, American Herbal Products Association (AHPA)

As the 24th month of 2020 (or so it feels) comes to a close – the herbal and natural products industry continues to adapt to challenges brought on by the global pandemic and move our industry forward. From regulatory progress made virtually to creative...

Industry sounds alarm over Oregon’s proposed restrictions on hemp/CBD products

15-Dec-2021 By Hank Schultz

New rules proposed in Oregon that would see restrictions placed around the sale most full spectrum hemp extracts have sounded alarm bells in the hemp/CBD industry. Stakeholders are scrambling to respond before the rules go into effect, which could be...

Another phenibut product shows up in warning letter

13-Dec-2021 By Hank Schultz

An FDA warning letter to the marketer of a product containing phenibut took the company to task over noncompliant disease claims but made no mention of the legal status of the ingredient itself.

Saffron supplement marketer dinged for wide ranging disease claims

01-Dec-2021 By Hank Schultz

The marketer of a trio of saffron products has received an FDA warning letter citing numerous alleged impermissible disease claims.

Trade organizations welcome Califf’s formal nomination to lead FDA

12-Nov-2021 By Hank Schultz

As expected, the Biden Administration has nominated Dr Robert Califf, MD, as the new FDA Commissioner. Dr Califf previously served in the role during the Obama Administration.

Threats in mandatory product listing discussion need to be made clear, NPA chief says

11-Nov-2021 By Hank Schultz

The push for a mandatory product listing is a solution in search of a problem, NPA’s chief executive maintains. Advocates of the requirement aren’t giving enough credence to the pitfalls, he maintained.

China’s supplements customs registration: ‘Clearer info’ on international authorities facilitating registration

01-Nov-2021 By Tingmin Koe

There are new updates to China’s customs registration, which will affect all food and supplements exports, with clearer information on the corresponding overseas authorities that are in charge of helping companies with their registration process.

Lawmaker’s letter to FDA demands clarity on NAC issue

29-Oct-2021 By Hank Schultz

Rep. Jeff Duncan, R-SC, sent a strongly worded letter to FDA yesterday requesting clarity on the matter of NAC, NDI enforcement and other matters.

Experts say data doesn't support call to make high dose Vitamin B6 a drug

08-Oct-2021 By Hank Schultz

Vitamin B6 supplement dosages should be restricted to 10 mg/day or less, with higher dosages sold only as prescriptions, a citizen petition to FDA has requested. Industry stakeholders say the action is unwarranted and ignores already established safe...

Hangover cures keep coming despite FDA action

06-Oct-2021 By Hank Schultz

Despite a recent FDA enforcement action, bringing hangover products to market with provocative claims continues to be a siren call for the dietary supplement industry.

Noonan replaces Welch as acting director of FDA supplement office

28-Sep-2021 By Hank Schultz

FDA’s supplement office has a new acting director in a mandated internal personnel switch while the process to name a new permanent director drags on.

Health apps, wearable devices fall under data protection rule, FTC says

27-Sep-2021 By Hank Schultz

The Federal Trade Commission has issued a policy mandating that companies using health apps and wearable connected devices must comply with a rule governing how consumers must be informed if a data breach occurs.

Cohen-led team concludes phenibut warnings had no deterrent effect

22-Sep-2021 By Hank Schultz

A research team led by prominent industry critic Dr Pieter Cohen has found that FDA warning letters sent to companies using phenibut in dietary supplements didn’t prevent other firms from continuing to use the illegal ingredient.

Congressional supplements report harps on product listing, CBD issue

21-Sep-2021 By Hank Schultz

A new Congressional report on dietary supplements reflects recent priorities with a heavy emphasis on a proposed mandatory product registry and the CBD question.

Synthetic glycans developer issued warning over failure to file IND in COVID-19 trials

08-Sep-2021 By Hank Schultz

A company that develops synthetic glycans as targeted microbiome therapies has received an FDA warning letter over the way it has conducted two clinical trials.

Guest article

CRN: Don’t Sell Out DSHEA for CBD

25-Aug-2021 By By Steve Mister, President & CEO, Council for Responsible Nutrition

We all want an expedient solution to the stalemate with FDA over the legal status of cannabidiol (CBD), but the call to allow FDA to set a maximum safe level for CBD is antithetical to the law governing dietary supplements, DSHEA.

NPA files petition asking FDA to rule NAC as legal ingredient

19-Aug-2021 By Hank Schultz

The Natural Products Association has filed a citizen’s petition asking FDA to acknowledge NAC as a legal dietary ingredient. The molecule, which has been on the market for decades, was ruled last year as violative by the Agency.

FDA rejects two NDI filings on full spectrum hemp extracts

11-Aug-2021 By Hank Schultz

The US Food and Drug Administration has rejected two New Dietary Ingredient Notifications for CBD ingredients. Industry stakeholders said the fact of the rejections and some of wording used in the letters makes it clear that new legislation is likely...

FDA reiterates firm no to nasal sprays as supplements

11-Aug-2021 By Hank Schultz

A recent FDA warning letter to a CBD product manufacturer lays bare the risk of trying to get noncompliant delivery modes past federal watchdogs.

Korey Stringer’s tragic death changed supplement industry for the better, experts say

02-Aug-2021 By Hank Schultz

The passing of NFL player Korey Stringer two decades ago, and the implication of the popular ingredient ephedra in that tragedy, was a seminal event in the dietary supplement sphere. Experts agree it helped bring into being adverse event reporting for...

FDA adds herb similar to kratom to import alert list

23-Jul-2021 By Hank Schultz

FDA has issued an import alert on a Southeast Asian herb that reportedly has been used in a similar way to kratom, about which the Agency has also raised a red flag.

FDA’s Welch makes strong case for mandatory product listing during industry event

14-Jul-2021 By Hank Schultz

A mandatory product listing for dietary supplements would help FDA leverage its enforcement resources most effectively, Cara Welch, PhD, said during an industry event yesterday.

FTC finalizes ‘Made in the USA’ rule that includes possibility of fines

02-Jul-2021 By Hank Schultz

The Federal Trade Commission has issued its final ‘Made in the USA’ rule about how companies can make this claim on their packaging and in advertising.

Trade associations request additional $5 million in funding for FDA supplement office

04-Jun-2021 By Hank Schultz

Four trade associations have banded together to ask Congress to allocate an additional $5 million in funding to help the US Food and Drug Administration regulate dietary supplements.

CRN's petition sets 180-day deadline for resolution of NAC issue

02-Jun-2021 By Hank Schultz

The Council for Responsible Nutrition has filed a citizen’s petition with FDA requesting that the Agency reverse its decision that the ingredient NAC is not legal for use in dietary supplements. CRN states that FDA’s ruling on the matter, voiced in warning...

Introduction of Senate hemp market bill expected soon

17-May-2021 By Hank Schultz

A Senate version of a bill legalizing CBD as a dietary ingredient is reportedly slated to be introduced soon, perhaps as early as this week.

CRN says it’s working with lawmaker to clarify FDA's authority to regulate rogue products

28-Apr-2021 By Hank Schultz

The Council for Responsible Nutrition says it is in talks with sources on Capitol Hill on revisions to the definition of dietary supplements to give FDA firmer authority to rein in rogue products.

China focus: Health foods registration developments, probiotics and beauty in the spotlight

19-Feb-2021 By Tingmin Koe

In this round-up, we look at new developments concerning health foods registration regulations and the NPD efforts companies are making in the area of beauty-from-within and probiotics.

FDA yanks pending CBD enforcement proposal

27-Jan-2021 By Danielle Masterson

The White House Office of Management and Budget pulled six FDA guidances and rules from its review, including the proposal "Cannabidiol Enforcement Policy; Draft Guidance for Industry" — handing the CBD industry yet another setback.

As FTC turnover begins industry expects greater focus on consumer protection

20-Jan-2021 By Hank Schultz

Federal Trade Commission Chairman Joseph Simons announced his resignation yesterday, which begins the process of filling slots at the commission with Biden Administration appointees. A reformed FTC is likely to take a stronger line on consumer protection,...

No therapeutic claims or implied imagery: Major pitfalls to avoid when advertising supplements in NZ

17-Dec-2020 By Tingmin Koe

Companies advertising their dietary supplement products in New Zealand should avoid pitfalls such as making therapeutic claims, using imagery that implies therapeutic purposes, or overpromising a health outcome.

Beyond vitamins and minerals: China’s expanded health food raw material directory comes into effect in March

07-Dec-2020 By Tingmin Koe

China has officially announced the addition of fish oil and four other raw materials into the Health Food Raw Material Directory, which will come into force from March 1 next year.

Supplement OWL changes cut costs, speed data entry, CRN says

03-Dec-2020 By Hank Schultz

CRN has upgraded its Supplement OWL platform to make it easier to use, which the organization hopes will boost the use of database beyond its own membership.

China’s health claims update: SAMR unveils 24 new indications for public consultation

30-Nov-2020 By Tingmin Koe

China is revamping its list of permitted claims for health foods and has unveiled 24 new claims for public consultation.

Stakeholders find some alignment with AMA’s call for more FDA enforcement of supplement market

19-Nov-2020 By Hank Schultz

The American Medical Association has issued a new policy on dietary supplements that calls for more enforcement from FDA, labeling changes and other measures. Industry stakeholders found points of agreement with the group’s position, but also highlighted...