top of page

Asa Waldstein

Community, Compliance, Natural Health

Marketing Strategy Compliance √

Warning Letter Wednesday

A weekly exploration of FDA warning letters and enforcement trends

Digestive & Cholesterol Claims Cited in Warning Letter

Remove testimonials with claims

3/15/23

Animal Product Claims Under Increased Scrutiny

Old social posts are “active” marketing

2/22/23

FDA Crackdown on Monkeypox Claims

Learning from other’s mistakes is a good strategy

2/1/23

The First 2023 Warning Letter Belongs to a CBD Company

Remove COVID claims including on YouTube

1/11/23

Website “About Us” Claims Cited in Warning Letter

Discussing ingredient benefits is marketing

12/21/22

FDA sends 7 Cardiovascular Disease Related Warning Letters

11/30/22

Supplement Labeling Errors lead to Warning Letter

Common labeling errors can be avoided

11/9/22

Kratom Claims Enforcement Increasing

Opioid support claims are high risk

10/19/22

MLM Distributors Cited in FTC Lawsuits

Webinars are “fair game” for enforcement

3/8/23

GMP Violations Continue to be Cited in Warning Letters

Hire experts to help with 483 responses

2/15/23

Labeling Errors Lead to Warning Letter

Nutrient content claims must be compliant

1/25/23

Biomarker Claims Lead to Warning Letter

Expect arterial health claims to be cited in the future

1/4/23

Saying “Thanks” on a Social Post Leads to Warning Letter

Do not engage with customer “disease” testimonials

12/14/22

FDA Issues Five CBD-Related Warning Letters

CBD enforcement is top of mind for FDA

11/23/22

Walmart & Amazon Issued Warning Letters for Adulterated Products & Disease Claims

Distributors are responsible for the products they sell

11/2/22

Common Labeling Errors Lead to Warning Letter

Following label format is important

10/12/22

IBS & Cholesterol Claims Cited in Warning Letter

Scan marketing for “mid-risk” heart health claims

3/1/23

Incomplete 483 Responses Lead to Warning Letter

Key GMP learning opportunities explored

2/8/23

Male Enhancement Products Found with Drug-Spiked Ingredients

FDA will test suspicious products for drugs

1/18/23

GMP Inspection Leads to Online Scrutiny

Study citations are marketing

12/28/22

Tea Product Cited for Blood Sugar, Cholesterol & Cancer Claims

Product claims must be compliant

12/7/22

Product “Tags” With Disease Claims Elevate Risk

Ingredient research can be considered a marketing claim

11/16/22

Ayurvedic Product Company Receives Covid Warning Letter

Discussing ingredient benefits is a marketing claim

10/26/22

Small Herbal Company in Big Trouble for Disease Claims

“Brain Fog” claims related to Covid will attract scrutiny

10/5/22

bottom of page