Dietary Supplements Archives - Lachman Consultant Services, Inc.

Hemp oil, CBD chemical formula, Cannabis oil in pipette and hemp seeds in a wooden spoon, Medical herb concept

How Will These Warning Letters Impact the CBD Market?

By Bob Pollock Mar 10, 2021 CBD Dietary Supplements Enforcement FDA Regulatory Affairs

I must admit that the explosion in the CBD market surprised me. The Warning Letters have also been flying off of the computers at FDA with most addressing drug claims for such products. Maybe I have not seen this before in a Warning Letter, but the argument made in recent FDA Warning Letters regarding CBD […]

Jan

Petition to Request an Exemption from 100‑Percent Identity Testing of Dietary Ingredients Image

You Just Can’t Go a Week Without Seeing FDA Action on an ED or Weight Loss “Supplement”

By Bob Pollock Jan 20, 2021 Dietary Supplements FDA Regulatory Affairs

So, here is my question – when will the Congress and the FDA get off their butts and do something about active pharmaceutical ingredients appearing in dietary supplements or the other issues with dietary supplements that occur over and over? This is not a new problem. We have posted about it numerous times here, here, […]

Oct

FDA/DOJ Gets Tough on Illegal Dietary Ingredient DMAA

By Bob Pollock Oct 19, 2020 Compliance Dietary Ingredients Dietary Supplements FDA Regulatory Affairs

Two executives of a dietary ingredient company were sentenced to sixty months and twenty-four months in prison, respectively, for their part in the distribution of two products, Jack3d and OxyElite Pro, touted as workout weight-loss supplements, both containing DMAA, according to a Department of Justice release (here). The FDA had warned consumers about the dangers […]

Apr

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

By Bob Pollock Apr 21, 2020 CBD Dietary Supplements FDA Regulatory Affairs Unapproved Drugs

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 […]

Mar

ADE Relief During Pandemic – But Only if You Need It!

By Bob Pollock Mar 21, 2020 Biologics Dietary Supplements FDA Generics Medical Devices New Drugs OTC

The guidances related to this COVID 19 pandemic (and I guess in preparation for the next one) are flying off the printers at the Agency. The FDA issued this Guidance directly with no public comment on March 20, 2020. It takes into consideration the potential impact of the pandemic on staffing level that may interfere […]

Nov

Hope at This Time of Giving Thanks

By Bob Pollock Nov 26, 2019 505(b)(2) Abuse deterrent Accelerated Approval Advertising Analytical Methods ANDAs Approvals Bioanalytical Bioequivalence Biologics Biosimilars BLA Brand Name Drugs Bulk Drugs List CBER CDER Chemistry Clinical CMC Combination Products Complex Generics Compliance Compounders Compounding Controlled correspondence CVM Data Integrity DEA Device Dietary Supplements Drug Pricing Drug Shortages eCTD Emerging Technology Enforcement Exclusivity FDA FDA First Generics Foods GDUFA Fees Generics Guidance Homeopathic Drugs ICH Imports International Label Changes Labeling Laboratories Manufacturing Medical Devices NDA New Drugs OGD Opioids OTC Petitions PMA Post Approval projectsnowflake Receipts Regulatory Affairs Safety Science & Technology Shortages Training Uncategorized User Fees Validation

Just look around, watch the television, read the newspaper, and what do you see? Seems like very few reasons to be thankful. School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth. Climate change is threatening the future of our children, and the environmental controls […]

Mar

Dietary Supplements – Using Contract Manufacturers

By Michael Plover Mar 28, 2019 Compliance Dietary Supplements FDA

As many dietary supplement marketers are essentially virtual companies, all manufacturing and testing is performed by organizations contracted by the marketer. In the ten years or so since the dietary supplement GMPs went into effect, control of these contractors has been an ongoing challenge. Most dietary supplement marketers have demonstrated adequate control over their […]

Feb

Gottlieb Opens the Toolbox for Dietary Supplements – Beware the Hammer!

By Bob Pollock Feb 11, 2019 Dietary Supplements Enforcement FDA Regulatory Affairs

In our blog, over the years, we have addressed the issue of dietary supplements and some actions of bad actors relative to the chase for the almighty dollar. Today, Commissioner Gottlieb announced the “agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight” (here) . The Dietary Supplement Health and […]

Dec

Happy Holidays from Us to You!

By Bob Pollock Dec 20, 2018 ANDAs Approvals Bioequivalence Biologics Chemistry Combination Products Complex Generics Compliance Compounding Data Integrity Dietary Supplements eCTD FDA FDA Generics Guidance Manufacturing NDA News OTC Regulatory Affairs Science & Technology Shortages Training Uncategorized User Fees Validation

To all of our readers – Have a happy holiday season and a very happy, healthy, and prosperous New Year. The Lachman blog will be taking a break over the holiday starting Friday, December 21st (unless something extremely urgent occurs) and I hope that all of you will rejoin me in the New Year as […]

Nov

Businessman Standing With A Target On His Back

Do Dietary Supplements Have a Target on Their Backs?

By Bob Pollock Nov 21, 2018 Compliance Dietary Supplements FDA

In a statement released by the FDA (here), the Agency cited warning letters to two “companies for the illegal marketing of products labeled as dietary supplements that contain tianeptine, a chemical compound that companies are illegally claiming treats opioid use disorder (OUD), pain and anxiety, and other unlawful and unproven claims.” The Agency noted that […]

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