Compliance Resources to Help you Stay Current

Malaysian Health Ministry Bans 10 Cosmetic Products

The Health Ministry in Malaysia has banned 10 cosmetic products, and advised the consumers to be more vigilant while purchasing the products online. Its deputy minister, Datuk Seri Dr Hilmi Yahaya said, “Every shop has the scanner and buyers can scan the product. If the hologram does not appear, it means that the item does not have the ministry’s approval. I urge everyone to be careful as selling of fake cosmetics via the Internet is on the rise.”

Can AT&T Acquire Time Warner Without FCC Oversight?

Given the ocean of differences between AT&T and the FCC (Federal Communications Commission), be it in conforming to regulatory protocols or in legal disputes, the telecommunications giant seeks to acquire Time Warner, without FCC oversight. A media merger of mighty proportions sans the regulatory agency at its heels has raised questions aplenty – with guarded responses from both sides regarding its execution.

The FDA’s new strategic plan: open for public comment

I am late getting to the FDA’s July announcement of the release of its work plan for the next ten years, Foods and Veterinary Medicine (FVM) Program’s Strategic Plan for fiscal years 2016-2025

Pepsi to reduce sugar in its drinks? Really?

PepsiCo, yesterday, announced that it had launched its sustainability report with an agenda for 2025.

The sustainability promises look good, but reporters called me for comments only on the first goal in its Products agenda:

Six US senators push FDA for a ban on medical devices that are used to administer electric shocks to patients with developmental disabilities. With the view to help modify their behavior, the senators wrote to FDA petitioning Commissioner Robert Califf to cement a ban that would outlaw the use of electrical stimulation devices employed for treating aggressive behavior.

A few months earlier, the FDA proposed a similar ban on devices that use electrodes attached to the skin to deliver electric shocks to prevent individuals/patients from engaging in certain behavior. In addressing these proposals to bar the devices, the FDA said it “determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be corrected or eliminated by labeling.”

Currently, the FDA is in the process of reviewing public comments submitted in response to the proposal.

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What are DHF, DMR and DHR? - The FDA Quality Systems Regulations Records Explained

What will FDA expect and request from your firm during Design Control portions of Inspections?

The US Food and Drug Administration (FDA) published a final guidance on October 14, 2016 describing how the Generic Drug User Fee Amendments of 2012 (GDUFA) relates to prior approval supplements (PAS) submissions. The guidance also explains the amendments to PASs for abbreviated new drug applications (ANDAs) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)).

A draft guidance, published by the State Council's Legislative Affairs Office, is soliciting public opinion for revising and regulating China’s online food sales. The draft regulation calls for stringent liabilities and rules for food producers and operators of online sales platforms. It also states that China's food safety laws and regulations must be applied to its food imports and exports through e-commerce channels. The public invite to comment through multiple means will stay open till Nov. 19.

Laying Down the Law: Japan’s Message to UK and EU Over Brexit

“There are numerous Japanese businesses operating in Europe, which have created 440, 000 jobs. A considerable number of these firms are concentrated in the UK. Nearly half of Japanese direct investment intended for the EU in 2015 flowed to the UK, and the UK was one of the major destinations for Japan’s investment stock within the EU as of the end of last year.”

                                                                                                                  - Ministry of Foreign Affairs of Japan

Corruption at a major sporting event takes away something from the integrity of the game. On an organizational front, corruption takes away from business integrity too. Consequently, committees have been set up, stringent laws have been enforced, and staggering penalties have been levied – but has the lesson hit home?

The laws that champion the cause are many, but here’s a look at a few global game changers.

Code Name Prometheus aka The Panama Papers

It has all the trappings of a spy thriller – an offshore corporation that creates shell companies for wealthy investors to evade tax, the big names involved, and a band of journalists hot on their trail for over a year. Pushing past WikiLeaks and Edward Snowden, the Panama Papers now leads as the biggest whistleblower in history – with over 2.6 terabytes of data to quantify it.

Does your medical device require a 510(k) application? The process of submitting a 510(k) application can pose many challenges for device manufacturers as each 510(k) submission is dynamic depending on the type of device, the risk level, its history, etc. A final 510(k) submission should be a completed comprehensive document including all 21 sections and other information needed for approval by the FDA. Therefore, it is vital to have a strong understanding of the latest 510(k) submission requirements and how they relate to your device.

The Thing About Bitcoin

Are they risky or can they be the decentralized wonder currency that can make monetary transactions just that much easier? The question abounds shortly after Hollywood Presbyterian Medical Center paid a ransomware to regain control over their IT systems after an 11-day battle with hackers. The payment mode? 40 bitcoins worth about $17000.

A Diverse Workforce, A Diverse Era

Paris. Beirut. San Bernardino. Three cities, three acts of terrorism – and all within a span of few weeks. Investigations are prompt and the perpetrators traced, and yet, questions and opinions swirling around cultural conglomeration at our workplace and community looms large and threatens an economy that depends on this very conglomeration. What then are the barriers that could keep us from accommodating the good and doing away with the obstructive?

The FDA has just approved AquAdvantage's genetically engineered (GMO) Atlantic salmon. The salmon will not have to be labeled as GMO.

What's Safe in Your Medicine Cabinet: Dietary Supplements in the U.S.

From regulating hormone levels to supplementing nutritional deficiencies in children, dietary supplements have a broad spectrum of needs to cater to. Popping a vitamin pill or biting down on an energy bar is not as simple as it once was though. The plethora of products available to supplement your diet are so staggering that regulating what reaches the consumer has been a challenge of equal proportions.

When the FDA first decided it was time to regulate dietary supplements in the early 90s, the agency drew a lot more flak than it could have anticipated. The flak came from trade associations of dietary supplement manufacturers and consumers. The industry has since witnessed a booming growth, resulting today in the need for FDA to step in with guidance and oversight for its labeling, marketing, and post-marketing as well.

Anticipating and Closing Out FDA Warning Letters

How can an FDA regulated company know that a Warning Letter is definitely on its way? What are the signs that can help firms anticipate a letter from the regulator? What is the groundwork that can be done before the receipt of the Warning Letter so that when it indeed arrives, the company is ready for it and implements the close-out process quickly and effectively? The answers to these questions are vital in ensuring the FDA Warning Letter response and close-out program is handled in a thorough manner that leaves nothing to chance.

Last month, the New York City Board of Health voted to require chain restaurants to publish warnings when menu items contain more than the recommended daily limit for sodium, thus taking the lead on regulating the amount of salt in foods.

USDA and HHS announce that sustainability will not be part of the Dietary Guidelines.

This year, we will release the 2015 edition, and though the guidelines have yet to be finalized, we know they will be similar in many key respects to those of past years. Fruits and vegetables, low-fat dairy, whole grains and lean meats and other proteins, and limited amounts of saturated fats, added sugars and sodium remain the building blocks of a healthy lifestyle.

Caught in the Marketing Melee: Inbound vs. Outbound

Out with the old, in with the new. This mantra never really rang true with marketing. Older marketing techniques continue to hold their place, while making room for newer platforms and strategies. The playground is fairly level now. But which side are you on?

Banking and Marijuana: Unlikely Partners in Fighting Crime?

Conflicting federal and state laws often set the stage for interesting and pressing debates. While the arguments over legalizing marijuana rages on, nothing really can be done to stop where this is headed. With one half of the US legalizing the use of marijuana in one form or the other, read medical or recreational, and four states and D.C. legalizing possession for recreational use, it’s no longer about the debates, it’s about creating a robust ecosystem to strengthen the legal parameters.