Dietary Supplements

01
Mar
medical fraud

FDA Provides Advisory on Two More Dietary Supplements with Hidden Drug Ingredients

Yesterday, the FDA advised consumers not to use QUICK Rheumatism Capsule, Tiger Wang Biaod (here) or SNAKE BONES Anti-Rheumatic Capsules (here).  The FDA confirmed by its laboratory analysis that both products contain piroxicam, a prescription drug ingredient for treating pain and arthritis-related symptoms. Serious adverse events can occur with taking any of these unapproved drugs […]

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22
Nov

A New Wave of Warnings for Pain Relief Products with Hidden Drug Ingredients 

Just like the FDA says on its warnings and notifications page (here):  “It is clear from the results of our decade of testing that retailers and distributors, including online marketplaces, do not effectively prevent these types of potentially harmful products from being sold to consumers. FDA cannot test all products on the market that contain […]

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19
Oct

Food for Thought!

Jim Jones was appointed Deputy Commissioner for Human Foods in August 2023.  Through the leadership of FDA Commissioner Robert M. Califf, M.D., the overhaul of the FDA’s food program is getting well-deserved additional attention as it protects our food supply and dietary supplements.  Under the new unified Human Foods Program (HFP) to be led by Jones, […]

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23
Aug
Here’s a Surprise! FDA Warns About Undeclared Active Ingredients in Sexual Enhancement Products!

Here’s a Surprise! FDA Warns About Undeclared Active Ingredients in Sexual Enhancement Products!

Today FDA has warned consumers (here) that the products listed below that are offered for sale in the US contain undeclared active ingredients that can be dangerous for some users. This is not really a surprise as unscrupulous manufacturers and distributors try to cash in on patients with erectile disfunction or on users that merely […]

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06
Jul
MaPP 5014.1 - Understanding CDER’s Risk‑Based Site Selection Model - Lachman Consultants

MaPP for Site Surveillance Inspection Procedure Gets a Facelift

The FDA has just revised its MaPP 5014.1 titled Understanding CDER’s Risk‑Based Site Selection Model.  Remember, MaPP stands for Manual of Policy and Procedures, and MaPPs instruct internal FDA staff on proper procedures.  The FDA publishes these MaPPs to provide greater transparency to stakeholders so they can better understand how the Agency does something or […]

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11
May

In the First 11 days of May FDA Warns Against Use of 21 Products

While we know there are probably thousands of unapproved drug products being marketed in the US, many of which claim to be dietary supplements which have undeclared drugs in their composition, the danger of these products cannot be understated.  Just search the web for erectile disfunction products, weigh loss products, products claiming to prevent, cure […]

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07
Mar

FDA Announces Dietary Supplement List

In recent years, there have been endless FDA actions on adulterated and/or misbranded dietary supplements. In addition, almost every week, there are warning letters or FDA public health announcements regarding dietary supplements released by the Agency. The FDA does not approve dietary supplements, but they do regulate them.  This is a confusing area for the […]

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11
Jan

FTC Issues Newly Revised Health Product Compliance Guidance – How About That!

Just one day after expressing my opinion that more needs to be done to enhance dietary supplement regulations and requirements, I found that the FTC recently revised an older guidance (from 1998) entitled Dietary Supplements: An Advertising Guide for Industry. The new guidance entitled Health Product Compliance Guidance (here), was issued on December 20, 2022 […]

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10
Jan

Failure of Congress to Take Action on Dietary Supplements Keeps Status Quo

Seemingly every day, there is news of a dietary supplement (DS) running afoul of regulations, either by containing a hidden drug ingredient or claiming the product is used in the cure, mitigation, or treatment of a disease, running afoul of the existing FDA dietary supplement regulations.  Congress had the opportunity to redefine FDA oversight of […]

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