Round-up on FDA compliance

This is the fourth in a series of seven posts about regulatory compliance priorities and enforcement trends.  The first post was about the Commodity Futures Trading Commission (CFTC).  The second post was about the Federal Trade Commission (FTC).  Last week’s post was about the Securities & Exchange Commission (SEC).  Today’s post will be about the Food & Drug Administration (FDA).  Next week, on Thursday January 18, the post will be about the U.S. Department of Agriculture (USDA).  On Thursday January 25, the post will be about the Environmental Protection Agency (EPA).  Finally, on Thursday February 1, the post will be about the Federal Communications Commission (FCC).

The Food & Drug Administration (FDA) is the US regulator charged with supervising and enforcing federal  laws concerning food, tobacco, dietary supplements, medications and medical treatments and devices, cosmetics, and animal and veterinary products, among other related products and devices related to public health and food safety concerns.  The FDA was created in 1938 by the Federal Food, Drug and Cosmetic Act, which gave the FDA oversight on food, drugs, and cosmetics and now constitutes of the major bodies of federal securities law it is responsible for enforcing.  Other significant statutes within the purview of the FDA – either wholly or partially, in collaboration with other federal supervisory and regulatory entities – include the Public Health Service Act (from 1944, concerning the prevention of foreign communicable diseases within the US) and the Controlled Substances Act (from 1971, creating federal US drug policy).

The food, medical, and veterinary products that fall under the regulatory purview of the FDA represent a significant proportion of the consumer goods imported into, purchased within and used in the United States, meaning that the FDA has broad reach into people’s everyday lives and therefore wide oversight duties to ensure adequate protections.  Food, drugs, cosmetics, and vitamin supplements are the largest categories of consumer products regulated by the FDA.  The FDA’s regulatory powers are broad in scope, including a huge array of business practices, from development, testing, and manufacturing to advertising, labeling, marketing, sales, and supply chain safety.  Enforcement of standards, oversight and monitoring of practices, approval of products, and handling of violations gives the FDA a heavy footprint in its covered industries.

  • Homeopathic drugs: The mandate of the FDA to regulate a variety of medicines and related treatments extends to addressing homeopathic drugs.  These products are widely available to consumers but previously have been lightly regulated.  Given burgeoning consumer protection concerns due to public harm from products that do not have any value as medical treatment and can in fact injure people or make them sick, the FDA is planning to take a more active role in the homeopathic drugs market.  Since the 1980s, the FDA has had a policy of not using the full weight of its enforcement authority with homeopathic drugs because their impacts were thought to be so minor that they could not be dangerous.  However, as more people have started using these homeopathic remedies, the risks and need for protection, especially for infants, children, and elderly people, have grown.  Last year children were sickened and even died from using homeopathic teething remedies sold at CVS due to poisoning from belladonna, which the medicines contained in dangerous proportions.  Testing, approval, oversight practices, or some combination of the above are apparently necessary for ensuring that these products do not hurt people, contain the ingredients they are supposed to in the amounts they should, and can provide medical benefit to support the health-related claims made by the manufacturers to consumers:  FDA to target ‘potentially harmful, unproven’ homeopathic drugs under new proposal
  • Cryotherapy: On a similar note, cryotherapy – immersion in a chamber cooled to as low as -132 degrees Celsius to treat inflammation and all kinds of other ailments and discomforts – has been spreading in popularity and caught the attention of the FDA.  Cryotherapy is often billed as a kind of spa treatment and has won the endorsement of athletes and celebrities for its health benefits.  However, the FDA has reacted skeptically to these claims, especially as people have been injured by unprofessional service providers or attempts to administer cryotherapy “treatments” to themselves.  If people continue to view cryotherapy and other popular science type activities and procedures as giving them some medical or curative benefit, which seems likely, then the need for the FDA to intervene by setting standards and providing oversight will grow alongside the popularity:  The spread of cryotherapy
  • Opioid epidemic: The FDA is well-positioned to contribute to efforts in containing the public health emergency of opioid drug abuse.  The FDA is responsible for overseeing both the number of prescriptions issued and the introduction of drugs to curb and treat addiction.  Overhaul of the system in which opioids are prescribed, and the rationale behind the length of prescriptions, is in the reform jurisdiction of the FDA.  This system would likely be funded by the pharmaceutical companies that make opioids, similar to what is already done to pay for other similar programs covered by the FDA’s enforcement authority.  Prescription intervention as well as the expedition of new versions of drugs to treat addiction will be priorities of the FDA on its upcoming regulatory agenda:  FDA plans to curb prescriptions to fight opioid epidemic
  • Gene therapy: Apart from approval of drugs, the FDA is also tasked with approving medical treatments.  Gene therapy has been a hot topic in bioethics for years, with questions about the use of stem or other cells from humans having dogged the technology’s development for years, but having promising treatments for genetic diseases now finally in its pipeline.  The FDA recently approved the first genetic therapy for an inherited disease, a rare form of childhood blindness.  The price of the approved treatment is currently astronomical, at almost $1 million, but the hope is that the FDA approval will open the door for further development that could lead to lower prices and improved benefits over a lifetime.  FDA openness and speed in considering and approving these technologies will certainly have an encouraging impact on the innovation within the field and the introduction of further treatments using gene therapy and improving upon knowledge and practices around it:  FDA approves first gene therapy for an inherited disease  
  • Food safety and recalls: Finally, the FDA’s food safety and recall programs may be an active area for reform and extended consumer protections going forward.  The FDA’s broad authority for food safety inspections has been critiqued in the past for culminating in uneven enforcement efforts.  Most recently, the Office of the Inspector General at the Department of Health and Human Services and the Government Accountability Office have both exposed shortcomings in the FDA’s enforcement of food safety policies.  Inspections, follow-up on food safety violations, and supervision of and collaboration with state-level regulatory personnel have all been found lacking:  Watchdog audits fire warning shots at the FDA’s food safety program

Addressing these deficiencies in the oversight process, and following with substantive improvement in the food recall process, has major implications for consumer safety.  The recall process in particular is crucial for ensuring that any gaps from the production and distribution processes oversight that are not filled, are caught before contaminated and dangerous food and supplements are sold to consumers.  However, audits have found that the recall process is not up to muster, indicating that they take way too long to kick off and that the FDA does not do enough to compel companies to cooperate with their warning letters and issue recalls:  The FDA Is Still Scary Slow at Food Recalls

Be sure to check back next week for a round-up on USDA regulatory compliance.

Round-up on SEC compliance

This is the third in a series of seven posts about regulatory compliance priorities and enforcement trends.  The first post was about the Commodity Futures Trading Commission (CFTC).  Last week’s post was about the Federal Trade Commission (FTC).  Today’s post will be about the Securities & Exchange Commission (SEC).  On Thursday January 11, the post will be about the Food & Drug Administration (FDA).  On Thursday January 18, the post will be about the U.S. Department of Agriculture (USDA).  On Thursday January 25, the post will be about the Environmental Protection Agency (EPA).  Finally, on Thursday February 1, the post will be about the Federal Communications Commission (FCC).

The Securities & Exchange Commission (SEC) is the US regulator charged with enforcing federal securities laws and supervising the securities industry, including the market exchanges.  The SEC was created in 1934 by the Securities Exchange Act, which is one of the bodies of federal securities law it is now responsible for enforcing.  Other significant statutes within the purview of the SEC include the Investment Company Act of 1940 (regulating registration and conduct of investment companies), the Investment Advisers Act of 1940 (regulating registration and conduct of investment advisory organizations), and the Sarbanes-Oxley Act of 2002 (regulating accounting practices of public companies and ensuring investor protection).

As indicated by this last piece of legislation, which was introduced into law in the aftermath of a series of corporate scandals such as the Enron bankruptcy, the regulatory scope of the SEC has grown in both breadth and depth as a reaction to financial frauds and crises of the last two decades.  This increased emphasis on the role of the SEC in reaction to these events aligns with the SEC’s mandate, which is three-pronged: investor protection, maintenance of fair, orderly, and efficient markets, and facilitation of capital formation. Ensuring that investors can retrieve and rely on information provided by public companies and in the markets in order to make their investment decisions is a major priority for the SEC.  Maintaining a level playing field in the markets is therefore the SEC’s objective, and preventing or eliminating market abuse and unfair corporate practices contributes to achieving this goal.

From both its Washington, D.C. headquarters and its regional office, the SEC offers education programs, promulgates rules and guidelines, conducts investigations, supervises self-regulatory organizations in the trading and markets industries, oversees disclosures by public companies, and brings enforcement actions in light of suspected violations of federal securities laws and regulations.  Based on this diverse range of activities, the SEC is responsible for exacting competent authority over a wide variety of issues and interests that comprise its regulatory agenda and rule-enforcement practices.

  • Cryptocurrencies: The hot topic of 2017, digital currencies derived from blockchain technology such as bitcoin and Ethereum will likely endure in the public attention in 2018 as well.  Regulators worldwide have sounded a cautious note about the potential risks of the cryptocurrency markets, and widespread legitimate use of the payment service technology as a disruptor to the banking sector is still in its infancy.  There is no unitary approach to protection of users who transact in cryptocurrencies on platforms that do not treat them as customers and supervision of markets where companies use initial coin offerings (ICOs) to offer their tokens without the rigors of securities registration to the public.   Innovation has been prioritized over strict supervision; some balance between the two, rather than supremacy of one over the other, needs to be struck.  The SEC has issued a concise and clear statement on its preliminary opinion of cryptocurrencies, stopping short of bringing them all into their regulatory scope as securities but providing definitive guidance on its views and a clear indication of the direction its future treatment could take:  The SEC Chair’s Cryptocurrency Warning: 5 Things to Know
  • Whistleblowers in Silicon Valley: As discussed in this previous post about the CFTC, the SEC has a powerhouse whistleblower program.  This has enabled the SEC to encourage individuals to step forward to anonymously report misconduct, corruption, and fraud in exchange for employment protections and compensation.  Due to the concentration of the SEC on the securities industry, traditionally these whistleblowers have come from the financial services industry (for an overview of some significant whistleblowers in recent history from this sector, check out this post).  However, there’s a new proving ground for whistleblowers who may stand to take advantage of the SEC’s program: Silicon Valley.  Venture capital firms and huge private companies which take funds from investment companies or individuals – including Uber, Airbnb, and many other digital giants – are all subject to the rule-making and enforcement authority of the SEC:  Silicon Valley could be the next hotspot for SEC whistleblowers
  • Cybersecurity as facilitation of market abuse: 2017 was the year of several very public and damaging scandals involving cybersecurity lapses and data breaches.  It remains to be seen in 2018 how the disclosure and reporting expectations and requirements for companies suffering hacks and intrusions may be refined or expanded in the wake of public outrage.  One concerning theme which emerged in a number of the cases was the perception of or possibility for insider dealing.  This was either due to material knowledge of company executives about the breaches before they were publicized or the theft of financial data by hackers.  The SEC’s Market Abuse Unit’s Analysis and Detection Center will probably keep busy identifying and analysing patterns in trades that could be suspicious due to their connection or temporal proximity to cyberattacks:  SEC, DOJ charge seven with insider trading off stolen bank data
  • Prioritizing investor protection amid regulatory rollback: Ponzi schemes, misrepresentations to investors, and fraudulent corporate practices are not going to vanish from the markets any time soon.  In fact, as business becomes increasingly global and complex in nature, the risks of these events only grows.  At the same time, the overall trend in the United States is toward a regulatory ebb.  The emphasis is on leaner and more targeted regulatory action rather than an expanded or wide-ranging supervisory framework.  The question remains how major cases such as the SEC’s recent suit against Woodbridge Group over a massive Ponzi scheme will be handled amid this regulatory relaxation:  SEC sues bankrupt Woodbridge Group over $1.2 billion Ponzi scheme
  • Enforcement decline: Finally, and on a related note, many recent commentators have pointed to a decline in SEC enforcement actions as evidence that the agency’s regulatory touch will be diminished in the near term.  However, these numbers may be deceptive; indeed, it could be true instead that this perceived decline is not due to regulatory inaction but quite the contrary.  Instead, it could be because of pipeline efficiency in clearing investigation and enforcement actions in the recent period:  Has The SEC Gone Soft Under Trump? Enforcement Actions Are Down, But That’s Deceptive

Be sure to check back next week for a round-up on FDA regulatory compliance.

Round-up on FTC compliance

This is the second in a series of seven posts about regulatory compliance priorities and enforcement trends.  Last week’s post was about the Commodity Futures Trading Commission (CFTC).  Today’s post will be about the Federal Trade Commission (FTC).  On Thursday January 4, the post will be about the Securities & Exchange Commission (SEC).  On Thursday January 11, the post will be about the Food & Drug Administration (FDA).  On Thursday January 18, the post will be about the U.S. Department of Agriculture (USDA).  On Thursday January 25, the post will be about the Environmental Protection Agency (EPA).  Finally, on Thursday February 1, the post will be about the Federal Communications Commission (FCC).

The Federal Trade Commission (FTC) is the US regulator charged with supervisory authority to protect consumers as well as enforce antitrust laws to avoid monopolies and ensure competitive business practices. Created in 1914 by the Federal Trade Commission Act, the FTC is an independent regulatory agency with the purpose to monitor the markets for anticompetitive developments and investigate and eliminate those where they emerge. Avoiding monopolies, known as trust, was a major political focus at the time the FTC was created and eliminating these large, anti-competitive business entities, known as “trust busting,” was an important priority for President Woodrow Wilson. The creation of the FTC was intended to bring an administrative efficiency to regulating interstate trade so that these trust and antitrust matters could be determined more expediently by the regulatory agency instead of working their way slowly through the courts.

In its current state, the FTC has broad supervisory authority over business practices where consumer protection or competitive processes are involved. The mandates of its various bureaus include protecting consumers against unfair or fraudulent acts or practices, enforcing existing antitrust laws, and reviewing pending mergers. These issues come from consumer and business reports, pre-merger notice filings, press reports, and congressional inquiries.

The FTC’s enforcement actions extend to individual companies, groups of companies, or industries with the main objective of addressing series consumer fraud or harm and preventing anti-competition business developments. With such a far-reaching set of interests, the issues and focuses that characterize the FTC’s regulatory agenda and enforcement priorities are equally diverse.

  • Consumer DNA testing services and privacy: Companies offering DNA testing services for everything from ancestry to genetic diseases to potential allergies to nutritional needs have become very popular in recent years. Most of these services involve consumers using a kit at home to collect samples of hair, skin, or saliva, which they then send to the company. The company then tests the samples itself or sends them to a third-party lab service for testing and then compiles results and analytical data into a slick, branded presentation that is sent back to the customer to study. If these services were performed in the traditional setting of a doctor’s office, the customer would be treated as a patient and would therefore be afforded commensurate protections and have expectations of privacy and informed consent for the collection, use, and storage of their genetic material. In the retail DNA testing service business, however, the duty owed to consumers is more dubious and the practices of companies less closely supervised or disclosed. As the popularity and prevalence of these tests continues, the FTC will likely look to standardize and investigate business practices of these companies:  Senator Calls on FTC to Investigate DNA Ancestry Companies
  • Use of consent decrees: The public and courts are taking a closer look at the often widespread use of settlement agreements by regulatory entities. The FTC typically uses these in enforcement actions in the data-privacy arena when companies experience breaches that puts consumer information security at risk. Consumers having their data stolen in cybersecurity compromises of payment systems or other retail financial data records. Settlement agreements and consent decrees are meant to apply to individual companies in federal-level, case-specific circumstances only, but the legal precedent has evolved for this common law practice to be potentially applied to establish liability under state law as well. In the continued use of consent decrees, the FTC needs to elucidate clearly what standards apply to constitute a violation and when and where liability may exist:  Federal Court’s Embrace Of FTC Data-Breach Settlements As ‘Common Law’ Treads On Due Process
  • Venue shopping for overlapping antitrust review: As noted in this post, major merger and acquisition activity is at a high pitch in the markets right now. Many large companies are seeking to merge with or acquire another and in lots of cases, regulatory review is exhaustive and detailed. Regulators seek concessions, order sales or exclusions to assets, delay transactions, and influence deals in both the press and Congress. In this intense environment, companies looking to merge with or acquire another approach these transactions hoping for the lightest regulatory touch possible. As there are overlapping supervisory schemes, companies can attempt to shop for the friendliest regulator who might green-light the planned transaction. The FTC and the Department of Justice (DOJ) both conduct antitrust reviews. The perception in the marketplace is that the FTC review may be easier to pass or less burdensome in terms of settlement requirements than that of the DOJ. Therefore some large companies – such as CVS in its planned deal with Aetna – would prefer to be subject to the FTC to improve their odds of passing muster:  CVS likely wants FTC antitrust review, not Justice Department, of Aetna deal
  • Occupational licensing reform: Portability of occupational licenses – such as those required for nurses and accountants – has long-been a challenging political and business issue. States have wildly varying educational and experiential standards for achieving and maintaining these licenses, often making it very hard for professionals who need them to work to move between states that have differing licensure requirements. Military spouses in particular often find themselves shut out of work due to family relocations. On the other end, consumers could be potentially harmed due to unmet expectations for professional service standards in states where the licensing schemes are more lax or supervisory enforcement is inadequate compared to others. Short of a concerted effort by multiple individual states, there is an authority vacuum in the task of making a coherent and coordinated system out of this patchwork of rules, tests, and qualifications. The FTC could be the appropriate regulator to intercede in these circumstances and create a reformed federal unifying system that would function to provide access to work as well as protect consumers’ interests:  The Onerous, Arbitrary, Unaccountable World of Occupational Licensing
  • Net neutrality: Finally, nearly any discussion of US federal regulatory compliance hot topics at the end of 2017 is incomplete without mention of one of the biggest themes of the time, net neutrality. As the Federal Communications Commission (FCC) is pulling back from rule enforcement on net neutrality, both the FCC and the public expect the FTC to take up a more prominent role. The obvious areas where the FTC would have jurisdiction would be those concerning information security, principally data privacy, as well as competitive practices of service providers as well as other digital companies. Time will tell what approach the FTC intends to take in filling this enforcement void:  After Net Neutrality: The FTC Is The Sheriff Of Tech Again. Is It Up To The Task?

Be sure to check back next week for a round-up on SEC regulatory compliance.

Round-up on CFTC compliance

This is the first in a series of seven posts about regulatory compliance priorities and enforcement trends.  Today’s post will be about the Commodity Futures Trading Commission (CFTC).  On Thursday December 28, the post will be about the Federal Trade Commission (FTC).  On Thursday January 4, the post will be about the Securities & Exchange Commission (SEC).  On Thursday January 11, the post will be about the Food & Drug Administration (FDA).  On Thursday January 18, the post will be about the U.S. Department of Agriculture (USDA).  On Thursday January 25, the post will be about the Environmental Protection Agency (EPA).  Finally, on Thursday February 1, the post will be about the Federal Communications Commission (FCC).

The Commodity Futures Trading Commission (CFTC) is the US regulator charged with supervisory authority over the futures and option markets. Created in 1974 by the Commodities Futures Trading Act, the CFTC is an independent regulatory agency with the purpose to monitor and protect the markets by prohibiting fraudulent activity or other misconduct and to control against risk from these. In the aftermath of the 2008 global financial crisis and the markets reforms which were implemented during the economic recovery, the CFTC has played a more prominent role in the largely unregulated general derivatives (contracts that derive their value from the performance of an underlying entity, such as an asset, index, or interest rate) and specifically, swaps (derivative contracts where two counterparties exchange cash flows of each other’s financial instruments) markets, to encourage transparency and gradually move toward a more stringent supervisory framework.

The CFTC’s principal mission is to ensure the successful and efficient operations of the futures markets, by keeping competition fair and preventing market abuse or other threats to financial integrity and efficacy. As the futures markets and particularly the derivatives and swaps markets are very international, the CFTC collaborates heavily with international partners and oversees a huge variety of diverse financial institutions and service providers, including exchanges, clearing houses, dealers, and commodity pool operators.

The CFTC has often been seen as the smaller, less powerful or prominent cousin agency to the Securities and Exchange Commission (SEC). However, as the CFTC refines its position within the financial regulatory landscape of the global markets and within the US economy, certain issues and emphases have emerged which distinguish the CFTC.

  • Bitcoin: The CFTC made headlines in November 2017 in paving the way for CME Group and Cboe Global Markets Inc to trade bitcoin futures contracts. Investors and markets professionals all over the world have been waiting for the first regulatory verdicts in the US on how cryptocurrencies markets may be handled. The CFTC has answered this boldly, indicating a permissive attitude toward the trading practices coupled with a strict expectation for robust monitoring and reporting to enable oversight of the famously volatile and active bitcoin trading markets. The CFTC had already declared in 2015 that it would treat bitcoin as a commodity, and the ensuing years have shown US financial regulators struggling to agree on what the cryptocurrency is in terms of financial markets and what risks and protections might be applicable for those wishing to invest or speculate in it. The CFTC has chosen to give the futures trading a yellow light, allowing it to go ahead with a cautious eye toward the intense enforcement and investor protection needs that could arise and obtaining assurances from the exchanges that they will proactively cooperate and share the necessary data with the CFTC: Bitcoin Futures Are Coming and Regulators Are Racing to Catch Up
  • Whistleblowers: While far outpaced by the SEC’s much more well-known and publicized whistleblower program, the CFTC’s program was created at the same time as the SEC’s, by the post-financial crisis Dodd-Frank Act in 2010. In 2017, while still modest in comparison to the SEC, the CFTC is having a banner year for payments of whistleblower rewards. These rewards come from sanctions imposed by the CFTC due to validated whistleblower claims against CFTC-covered organizations. This represents a reporting increase by whistleblowers to the CFTC of 70 percent over 2016, indicating that whistleblowers are recognizing the value of the CFTC as an enforcement body. Therefore this uptrend in handling of whistleblower claims could likely continue: Why Wall Street Should Worry About the CFTC Whistleblower Program
  • Deregulation: The overall trend in the US is toward a preference for fewer or more efficient and targeted regulations. This is a clear reversal especially in the financial markets, where in the years after the global financial crisis the momentum was toward more complex and far-reaching regulatory and supervisory oversight on the economy and market participants. This was a reasonable and necessary response to not only the recession but the numerous and varied financial scandals and frauds that were uncovered and damaged the markets and society’s trust in the financial systems. These risks and root causes of misconduct and abuse are still present, so balancing a regulatory posture which prefers a lighter touch against the need for investor protector and facilitation of transparent and equitable markets is a challenge for all regulatory agencies, including the CFTC: CFTC Enforcement Actions Drop Sharply in 2017
  • MiFID II: The revised Markets in Financial Instruments Directive, or MiFID II, is a wide-sweeping set of EU financial regulatory rules coming into effect in January 2018. These new regulations will have huge impact on the way banks and other financial institutions interact with and make money from the markets. While these are European laws, the globality of the markets means that regulators and market participants all over the world are contending with how to handle these new supervisory guidelines. The Futures Industry Association (FIA) has been actively lobbying the CFTC on behalf of its members, including large banks such as Goldman Sachs and Morgan Stanley, to confirm that the new European requirements will not bring expensive new limitations in the US as well: Wall Street Has New MiFID Migraine, Now in Futures Market
    In continuation of this, one important area in which the CFTC has already been deal-making with the EU in anticipation of the approaching MiFID II application is with derivatives trading venues. The European Commission and the CFTC have agreed upon mutual recognition of trading venues so that those in the United States can benefit from an equivalence decision recognizing them as eligible for compliance with MiFID II requirements by virtue of their satisfaction of CFTC requirements: EU and CFTC Implement Mutual Recognition of Derivatives Trading Venues
  • Blockchain: Apart from regulating bitcoin as a commodity, the CFTC hopes to benefit from the technology that underlies cryptocurrencies, blockchain. The CFTC has voluminous amounts of data from the diverse market platofrms and service providers that it supervises and has historically struggled to parse and study these huge troves of data efficiently and meaningfully. The CFTC hopes that the reporting reliability, transparency, and information security offered by the ledger technology blockchain can enable better review and analysis of this data. Traditional procurement requirements have often dogged attempts to implement more advanced or emerging technologies, but one of the priorities of the CFTC and other US government agencies currently is to leverage innovation such as from financial technology (fintech), regulatory technology (regtech), and supervisory technology (suptech): CFTC Looks to Blockchain to Transform How It Monitors Markets

Be sure to check back next week for a round-up on FTC regulatory compliance.

Compliance issues with marijuana legalization

Marijuana has a complex legal and regulatory history in the United States. Originally widely deployed in a variety of medical and commercial uses, the regulation and eventual restriction of commonly-accepted preparations of hemp and cannabis began at the turn of 20th century with labelling requirements and a push to include cannabis in the definition of a “poison” for which a prescription would be required. By the 1930s a patchwork of state and national policies in law were in place and the criminalization of marijuana was underway in earnest. For the next 40 years any attempt at decriminalization or reclassification was unsuccessful. In the 1970s and 1980s, however, California began to slowly reduce penalties for possession under state law and work toward legalization for compassionate use in chronically-ill individuals, which became legal in the state in 1996.

Since then, the legalization of marijuana has been a matter of legislative interest in many states. This move toward decriminalization at first was limited to the medical use first legitimized in California state law, either for chronically-ill patients or for those suffering from a variety of illnesses for which marijuana has proven to be a desirable treatment in terms of effectiveness and cost. Advocacy in this area has eventually extended to non-medical use; in 2012, Colorado was the first state to legalize recreational use of marijuana for adults.

As of the writing of this post, medical marijuana is legal (to at least some extent) in 23 states plus the District of Columbia; in 8 states medical and non-medical marijuana is legal to sell and possess. As the below selection will show, momentum for decriminalization and handling of emerging legal markets invokes a wide variety of compliance issues which will need to be addresses for business and consumer protections and obligations.

  • Given that medical marijuana was the initial purpose behind modern legalization and that it continues to be the most widely-accepted rationale for it, it follows quite logically that medical marijuana research would need to be recognized and facilitated by the law as well. Senator Orrin Hatch, a perhaps unexpected ally for legalization, introduced the Marijuana Effective Drug Study Act of 2017 to improve the research approval process and increase the national marijuana quota to provide supply for medical and scientific research into its potential health benefits. Because marijuana is still completely illegal at the federal level, it is subject to the most restrictive classification and therefore getting approval to study it or supply of it to study is very difficult. In order for the full efficacy of marijuana as medical and therapeutic treatment to be understood, these administrative burdens must be overcome: Senator introduces bill to make it easier to do medical marijuana research
  • Due to the fact that, as stated above, marijuana is still totally criminalized at the federal level, and state efforts toward legalization vary widely, regulatory expectations are widespread across a cumbersome patchwork. Businesses hoping to join or exploit the marijuana market in states where it is legalized to some extent will confront a huge regulatory burden of rules, reporting and disclosure obligations, and licensure requirements. It will be crucial for existing or new owners of marijuana-based businesses to consider implementing compliance programs early and thoroughly so that they are not caught unaware by government expectations in their jurisdictions. Otherwise, a culture of operational non-compliance will reign, which could have devastating effect on business success rates amid supervisory enforcement actions for deficiencies: Marijuana Businesses, Particularly In California, Struggle To Navigate A Thicket Of Regulations
  • Public sentiment is certainly trending toward legalization. Sixty-four percent of Americans now say that its use should be made legal, which is the highest level of public support that the pollster Gallup has found in the fifty years it has been recording this measure. Certainly high-profile ballot initiatives in a variety of states and increased media attention have come through to the average American and liberalized views on the matter. How will this impact regulatory outlooks? If the federal government comes around to legalization then some universal standard for controls framework and supervisory requirements may be in the future. If not, states will continue to be left to their own devices to create independent markets and risk controls within them:  Record-High Support for Legalizing Marijuana Use in U.S.
  • As the market for legal weed emerges, powerful people wanting to work within are starting to act like they would in any other industry – looking to garner competitive advantage and turn their companies into giants of the marijuana business. Marijuana is a valuable industry and can be seen as a crop, which means it has an agricultural supply chain like wheat or corn that can be exploited. Utility patents, intellectual property protection for crops, can be used by powerful organizations to corner the market on breeding of new varieties, conducting research, and even producing seeds to be licensed: The Great Pot Monopoly Mystery
  • With governments addressing legalization of marijuana all across the United States, organizations are beginning to weigh in too on what their policies of use by their members and employees may be. One visible example of this is with the National Basketball League (NBA) where both the former commissioner David Stern and the current commissioner Adam Silver have expressed at least awareness that the league policies may eventually have to change. While marijuana is still a prohibited substance in the NBA irrespective of the purpose of use, Silver has said he wants to study it and Stern has opined that he feels players should be allowed to do what is legal in their states with respect to marijuana use:  David Stern calls for NBA changes of marijuana rules

As states continue to move toward decriminalizing or outright legalization for marijuana for a variety of purposes, and other organizations contend with their own policies within that system, mechanisms for regulated markets will begin to emerge, presenting interesting regulatory compliance issues with no clear and easy precedent. Governments and businesses alike will need to contend with both the opportunities and the challenges this will present.

Compliance considerations in an active era of mergers and acquisitions

The term “mergers and acquisitions” describes transactions in which the ownership of organizations or business operations within organizations are combined or transferred between companies. Merger describes the combination of at least two organizational units, whereas acquisition describes the transfer of interests or assets from one organization to another.

So far 2017 has been a banner year for high-profile mergers and acquisitions across all industries. Businesses are generating attention, press, and perhaps even revenue for themselves by ambitiously entering into deals with one another. Some prominent competitors have decided to join forces, while other companies hope to make inroads into new markets or gain access to new technologies through mergers and acquisitions activity.

  • The Amazon/Whole Foods merger has been one of the hottest topics of late summer 2017. Already the deal has had a seismic effect on the market, causing competitors from European grocery retailers to ready-to-eat meal delivery companies to major retailers such as Wal-Mart to recalibrate their own corporate strategies and expansion plans. One of the focal points of the lively conversation around this transaction has been the speed with which the US Federal Trade Commission (FTC) gave its blessing. While some professional skepticism from lawmakers on this subject is certainly welcome, the proof will be the pudding as to whether the deal encourages innovation in the sector by challenging competitors to respond creatively to the merger. If this does indeed pan out, perhaps consumers will stand to benefit, not to be harmed, by this type of deal:  Consumers the big winners of Amazon-Whole Foods merger
  • In the UK, a different regulator is not in such a rush to approve the merger between 21st Century Fox, owned by Rupert Murdoch, and broadcaster Sky. The Competition and Markets Authority (CMA) will perform a six month review of that one on the referral of the Culture Minister Karen Bradley. The stated reasons for the review were concerns about media plurality, stemming from the material influence Rupert Murdoch would gain over news providers in the UK key market plaforms, and an inadequate compliance program at Fox, which already owns a 39 percent stake in Sky:  UK competition commission to review Fox-Sky merger
  • Mergers can complicate outstanding or future legal claims, as the union between chemical industry giants Dow Chemical and DuPont is indicating. The issue dates back to a major industrial accident in 1984 in India at a factory owned by Union Carbide India. The majority owner of this company was Union Carbide Corporation, which in turn was acquired by Dow in 2001. Victims of the gas leak accident, which killed as many as 22,000 people and left more than 500,000 others injured, have struggled in the last three decades to reach justice through the complicated system of corporate liability. This is a labyrinthine system of liability and procedural quagmires already for victims to make it through, and the acquisition of Union Carbide by Dow made defining liability, both in a legal sense and in a concrete moral sense to attach to an existing corporate entity, very complicated. Already complex enough when dealing with just Dow, now that DuPont will be in the mix, the corporate structures will become even more difficult to navigate legally:  Bhopal disaster victims may never get compensation following Dow-DuPont merger, fears UN official
  • Bayer AG and Monsanto Company are set to face a regulatory review by the EU over at least the next four months in the planned merger by the major agrochemical companies. In that same sector this year, Dow and DuPont as well as China National Chemical and Syngenta AG have faced similar regulatory hurdles and had to make serious sacrifices in order to settle with the EU For their consolidations to go ahead. As companies in one industry seek to merge with each other, the industry comes out reshaped entirely, and the regulator in charge of oversight must step up to ensure the consumers are protected and that innovation continues unchecked despite fewer competitors in the market:  Bayer-Monsanto merger faces in-depth EU probe
  • Similarly, EU regulators have also expressed concern about the merger between Italian eyewear-maker Luxxotica and French lens-maker Essilor. Together the two companies will form a $55.12 billion global eyewear retailer. The EU is concerned because the combined company will be so large, likely crowding out other, smaller retailers that cannot operate on the slim margins workable for major organizations. The regulator is particularly concerned about impact this merger could have on the supply chain, as Essilor will gain access to previously untapped markets in the Americas and Asia:  EU regulators have concerns over Luxottica-Essilor merger

One conclusion that may be drawn already so far from a survey of this year’s mergers and acquisitions activity is for some, that expediency is the name of the game. Companies entering into these agreements want to come together quickly to get on with business, before the advancements in technology outpace their own participation. In some markets, regulators seem basically happy to oblige them. This apparent trend stands somewhat in contrast with standard regulatory agenda for existing companies, and the current preference in other markets, which is to identify and investigate possible anti-trust business practices for possible enforcement action or remedial measures before allowing the deal to go through.

If the US regulators continue to take the point of view that combined and strengthened competition from one market player drives the rest to be better and innovate, such as with Amazon, this will be a justification of relaxed regulatory scrutiny. It will be interesting then to observe whether regulators in the EU or other regions trend in the other direction, increasing the scope and standard of their oversight in order to reinforce their opposite protection that in these times of combination innovation may actually be more at risk than ever.

Only time will tell in this case which side has predicted the outcome correctly; one may find commerce stifled in name of caution, while the other may discover that imposing supervision after the union is more difficult than taking a measured approach from the beginning.

Round-up on compliance issues in food technology

Food technology, concerning the production processes that manufacture, transport, and distribute foods, continues to expand as disruptive technologies in general advance. As any practice that impacts food has obvious heavy impact on consumer safety, food technology practices are coming under increased scrutiny. While public attention was once mostly limited to risk-benefit analysis of various foods and the resulting consumer preferences and perceptions, innovative technologies are driving further questions and desires for customer protections and process disclosures.

  • In response to perennial consumer demand for more flavorful and interesting plant-based products to present vegetarian and vegan friendly burgers, Impossible Foods created their Impossible Burger, with soy leghemoglobin giving it an uncanny resemblance to meat and a regulatory problem with the U.S. Food & Drug Administration; can high-profile investors and customer interest overcome food safety concerns and the burdens of government supervisory challenges:  Impossible Burger’s ‘Secret Sauce’ Highlights Challenges of Food Tech
  • Walmart and a consortium of major food companies including Unilever and Kroger are experimenting with blockchain technology to simplify and automate their supply chains, in hopes of making a very complex set of production processes much more agile and enabling quicker investigations into outbreaks of food-borne illnesses, with improved documentation:  Walmart and 9 Food Giants Team Up on IBM Blockchain Plans
  • Another fascinating, developing use of blockchain in order to make the supply chain safer by combating food counterfeiting and tampering, illegal shipping, and industry malpractice by tracking products through the process and requiring non-anonymous, reliable documentation, all informed by industry “spying” that has uncovered the causes of abuses across food business sectors and country cultures:  Inside the Secret World of Global Food Spies
  • Personalized nutrition plans combine the trend for home genetic testing with consumer desires for at-home meal delivery or menu selection services, but how does freedom of choice and a culture of individual preference with emphasis on customization fit in with the goals of libertarian paternalism that can be espoused by suggesting biometrically-determined food choices:  I sent in my DNA to get a personalized diet plan. What I discovered disturbs me. 
  • Amazon continues to search for growth opportunities in the food business after announcing plans to acquire Whole Foods earlier this summer, this time turning to U.S. military technology to aim to deliver meals that do not need to be refrigerated, but will consumers be enthusiastic or will this solution only create new potential problems in trademarking of kits and safe fulfillment of orders:  Amazon looks to new food technology for home delivery

Blockchain will likely continue to pose the most challenging and exciting advances in the food technology industry. Making the supply chain for food more transparent and accountable, and also simpler to navigate, is a lofty goal which would serve the public interest. Integrity and consumer choice in the food business, with or without the impact of regulatory supervision, should drive innovation going forward.

Theranos and the clash of financing emerging high-tech enterprises and regulatory compliance

The mysterious corporate life of Theranos illustrates many of the challenges that a disruptive business model faces when competitive ambitions take precedence over business foundations. A corporate environment that tolerates, or indeed relies, on a lack of ethical controls develops a culture where misleading and non-compliant conduct becomes the unsustainable norm.

Theranos is a technology company in the health care industry. It has become well-known for its eccentric, charismatic founder Elizabeth Holmes, a precocious and provocative entrepreneur who began developing the blood testing technology Theranos purports to be producing while she was a student at Stanford University. Theranos received tremendous attention from the media, undertaking several successful fundraising rounds and winning prized corporate partnerships and awards for its innovations on the basis of this publicity, all before any of its devices were ever proven effective.

Typical of many high-tech startups, Theranos operated in secrecy, with Holmes acting as its chief evangelist and marketer but speaking always in aspirational terms. Confidentiality, of course, has its place in launching new products to market – especially in the highly competitive and fast-changing technology industry. Beating other firms developing in the same space can make or break disruptive products and the companies that market them. However, these companies and their products have to be real, and an overemphasis on secrecy can also be a red flag for a pervasive fraud.

Unfortunately, all that glitters does not seem to be gold with Theranos. Despite huge valuations and capital raises, the blood testing technology has been criticized for lack of peer-review and has failed to stand up to validation studies. FDA inspection reports necessary before the devices could be sold on the commercial market indicated that the devices were not validated or approved. The media and scientific community turned skeptical of Theranos as time went on, and corporate partners have suspended or cancelled their engagements with the company, which is under criminal investigation by the U.S. government. Laboratories have failed inspections, lost their licenses and certificates to operate, and been closed. A whistleblower came forward regarding design defects in the blood testing technology, leading to a storm of negative publicity and investigations. The future viability of Theranos, and possible liability of Holmes herself for potential wrongdoing, remains uncertain.

Theranos and Holmes, who created a cult of personality around herself which even if briefly convinced the media, investors, the board, and the employees of Theranos to accept her at her word, perfectly illustrate the integrity pitfalls of financing a new company about which the investors are only allowed to know what they are told. Traditional critical review and the studied analysis of outside observers shouldn’t be abandoned in the heat of the venture capital moment due to the persuasion of a person who seems ambitious and charismatic. To do so could be as serious as enabling fraud at the expense of due diligence.

For more insight on the case of Theranos, Nick Bilton’s investigative report for Vanity Fair is an excellent resource.