Unapproved Drugs

17
Jan
Office of Compliance Issues FY 2023 Annual Report - Lachman Blog2

FDA’s Office of Compliance Issues FY 2023 Annual Report

Some of the big-ticket items mentioned in the FY 2023 report are Office of Compliance (OC) actions taken regarding the “contamination from diethylene glycol and ethylene glycol (DEG/EG), potentially harmful eye products, and mitigating risks from drug shortages while ensuring the safety our drug supply.” These issues caused the OC to “pivot” from its business as […]

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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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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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15
Aug

Something’s Not Right Here – How Does This Happen?

On August 8, 2023, Axios reported (here) that the Pentagon began contracting with Valisure, a drug testing facility, to test the generic drugs that it is purchasing.  On August 9, 2023, Bloomberg reported much the same thing in an article titled “Tainted Medicine Fears Spur Pentagon to Seek Outside Testing” (here; subscription required).  Congress has been pushing […]

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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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10
Jun

Moles Can Be Dangerous (and Not Just in Your Yard) – FDA Warns Consumers that Danger Lurks in Unapproved Products

The FDA issued a warning to consumers (here) that mole removal isn’t a DIY project and can be dangerous for a number of reasons.  It warns that there is no FDA-approved OTC product for removing moles or skin tags.  Unauthorized products, like those with a high‑level of salicylic acid, claiming to remove these lesions can […]

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14
Jun

Now that the Unapproved Drug Initiative Is Back on the Horizon, FDA Makes Noise About Unapproved Prescription Thyroid Drugs

In a recent Consumer Update published on its website, the FDA provides a very brief history of the origin of thyroid treatments, noting that the first versions of thyroid replacement products were made from the glands of pigs or cows.  The discussion moves on to describe the new generation (well, not too new) of synthetic […]

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24
Nov

Price Saving’s Short-Sighted Action by HHS – Unapproved Drug Initiative – Cancelled!

I marveled at the short sightedness of the Administration’s position to withdrawal the unapproved drug initiative to save the consumer money. Yes, there have been price increases when a firm has taken a previously unapproved drug product through the FDA approval system and the FDA forces the unapproved versions off the market.  Firms need to […]

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21
Apr

CBD Products – As FDA Resources are focused on COVID-19, will it be this virus that prompts FDA to regulate this Industry?

CBD products are available just about everywhere – you see them show up in gas stations, supermarkets, the internet, convenience stores, farm markets, and just about any place where things are sold.  CBD appears in drinks, pastry, candy, as an oil, and is infused in just about anything that can be orally ingested, or in […]

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