Warning Letter

FTC goes after doTERRA distributors for making unfounded COVID-19 cure claims

06-Mar-2023 By Danielle Masterson

The United States obtained permanent injunctions and civil penalties in actions against essential oils and dietary supplements distributors.

Warning letter alleges company used raw materials tainted with glass and plastic

24-Aug-2022 By Hank Schultz

An FDA warning letter sent to supplement manufacturer Oregon’s Wild Harvest said the company failed to demonstrate that it had a valid method for assuring that incoming raw material lots were free of contaminants.

Navigating the legal landscape of weight loss supplements

08-Feb-2022 By Danielle Masterson

Over 42% of adults in the US are considered obese—giving weight loss brands easy marketing fodder amid the obesity epidemic. Unfortunately, this category of supplements has a checkered history, and has become labeled as one of FDA's problem children.

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.

Market America removes deceptive income claims following watchdog warning letter

03-Nov-2020 By Danielle Masterson

An investigation by truthinadvertising.org (TINA.org) has dredged up hundreds of exaggerated income claims made by one multilevel marketing company through its website and social media platforms.

Warning letter shows silver products continue to crop up as coronavirus cures

30-Oct-2020 By Hank Schultz

Another seller of colloidal silver products has been warned by the US Food and Drug Administration over making COVID-19 treatment claims.

FTC to marketers: Stop making unsupported COVID treatment claims

17-Aug-2020 By Danielle Masterson

The Federal Trade Commission has sent another round of warning letters to marketers making unsubstantiated COVID-19 health claims. The FTC’s message is simple: Prove it or remove it.

FDA cites firm for failing to document adverse event investigations

29-Jun-2020 By Hank Schultz

A recent warning letter reiterates the importance of collecting adverse event reports in order to demonstrate full compliance with federal laws governing the manufacture and sale of dietary supplements.

Survey highlights consumers’ lack of confidence, need for education

10-Jun-2020 By Danielle Masterson

Life Extension recently released results from a survey which found that while Americans lack confidence in their supplements, they’re also not putting in the same research into vitamin purchases as they do for electronics.

Warning letters continue as pandemic rages on

26-May-2020 By Danielle Masterson

The Federal Trade Commission has sent out another round of warning letters to 50 more marketers nationwide, most of which are labeled as dietary supplements or Chinese herbs.

FTC refunds $8.5 million to consumers over fraudulent product claims

20-May-2020 By Danielle Masterson

The Federal Trade Commission just announced it is issuing refund checks totaling over $8.5 million to consumers defrauded by misleading claims on weight loss products an erectile dysfunction product in a case dating back to 2004.

Despite coronavirus dislocations, FDA, FTC not taking foot off compliance pedal

18-May-2020 By Danielle Masterson

The Food and Drug Administration (FDA) may have suspended all routine plant inspections, but dietary supplement producers are still expected to remain in compliance. In the meantime, the Federal Trade Commission has sent another 37 warning letters over...

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.

FDA warns 7 firms on COVID-19 claims including televangelist Jim Bakker

09-Mar-2020 By Hank Schultz

The US Food and Drug Administration has sent warning letters to seven companies that have been alleged to have been making COVID-19 disease treatment claims. Among the recipients of the warning letters is a prominent televangelist.

Contract manufacturer recalls products under more than 1,200 brand names

21-Jan-2020 By Hank Schultz

A New York-based contract manufacturer has recalled hundreds of lines of products manufactured over a period of almost seven years in a consent decree it publicized recently.

Warning letter shows FDA still enforcing status quo on CBD

07-Oct-2019 By Hank Schultz

FDA is continuing to crack down on the legality of CBD when a case comes across its desk, despite a call for an official enforcement discretion policy.

Use of aromatase inhibitor forms basis of warning letter

30-May-2018 By Hank Schultz

A recently posted warning letter cites a New York company for the presence of an aromatase inhibitor in one of its dietary supplements. This class of chemicals is popular with strength trainers for its purported ability to suppress estrogen levels.

FDA sends warning letters to 'sunscreen supplement' makers for overstating benefits

30-May-2018 By Adi Menayang

Many ingredient suppliers have invested in research exploring how ingesting carotenoids may protect skin from UV damage, but as warning letters from the FDA sent out last week show, sun protection is not a claim dietary supplements can make.

Cancer claims, CBDs and SARMs highlights of 2017 enforcement picture

21-Dec-2017 By Hank Schultz

The picture painted by warning letters issued by FDA in 2017 is a chiaroscuro of old and new. Familiar enforcement action on claims language contrasted with warnings on the use of new, unapproved ingredients.

FDA issues consumer warning on sports products that contain SARMs

01-Nov-2017 By Hank Schultz

The Food and Drug Administration has issued a consumer warning against supplement-like body building products that contain SARMs, or selective androgen receptor modulators.

Lack of adequate counsel when setting up operations can lead to big regulatory headache later

25-Sep-2017 By Hank Schultz

A recent warning letter to a Colorado dietary supplement company illustrates the hot water companies can get themselves into when starting business operations without adequate counsel.

Warning letters take note of herbal nomenclature, expert says

25-Jul-2017 By Hank Schultz

Making a mistake on an ingredient name can result in a specific call out on a warning letter, an expert cautions.

FDA uses warning letter to check up on DMAA recall

04-May-2017 By Hank Schultz

In an unusual move, in a warning letter to a dietary supplement company the Food and Drug Administration has sought information about a recall, in this case one involving DMAA products.

Literature from trade show booth puts company in hot water with FDA

25-Aug-2016 By Hank Schultz

A recent FDA warning letter emphasizes the importance of maintaining consistent messaging about a product to avoid crossing the disease claims line.

Whey maker gets warning on inflammation claims

05-Aug-2016 By Hank Schultz

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...

Organoleptic ID of botanicals still valid if supported with documentation, experts say

14-Jan-2015 By Hank Schultz

A recent FDA warning letter to a company making products based on whole dandelion parts and other herbs seems to call into question whether organoleptic identification of incoming botanical specimens still passes muster as far as the agency is concerned....

Churning out new, good news can help dilute past bad marks such as a warning letter, experts say

29-Jul-2014 By Hank Schultz

Bad news has acquired a long shelf life in the age of the Internet. Companies that are involved in regulatory actions, such as receiving FDA warning letters, need to develop a strategy to present their image going forward because the record of the warning...

Facebook and Twitter: FDA continues to monitor tweets and ‘likes’

09-Jul-2014 By Stephen Daniells

A new warning letter from the Food and Drug Administration shows that the agency is continuing to scrutinize activity on Facebook and Twitter just as carefully as it is looking at corporate websites.

Website claims, cGMP violations, and label claims: FDA warning letter round-up

04-Sep-2013 By Stephen DANIELLS

A new raft of warning letters for dietary supplement companies from the US Food and Drug Administration (FDA) shows that current Good Manufacturing Practice (cGMP) and label claims continue to cause problems for companies.

FDA warning letter gives important lessons for finished product testing, labeling and adverse event reporting

12-Jun-2013 By Stephen DANIELLS

A new warning letter from FDA for a company manufacturing products that contained only 5% of declared nutrient levels shows that the agency is stepping up its testing of finished products, say industry experts.

Website content an extension of labeling: FDA warning letter shows companies need to ‘think about their real estate space’

09-May-2013 By Stephen DANIELLS

The FDA has issued a warning letter for a company website that links to articles with disease claims cause products to be drugs (FDA), causing the products linked to such articles to be drugs.