Safety is a ‘Red Herring’ used by SAHPRA to regulate natural health products as medicines.

In the world of dietary supplements, the United States holds a unique position. Unlike many countries where strict regulations govern these products, the USA operates under a comparatively lenient framework. This regulatory landscape has drawn attention and occasional criticism from National Medicines Regulatory Authorities (NMRAs) worldwide, including the South African Health Products Regulatory authority (“SAHPRA”). But how did this come to be, and what does it mean for consumers?

The story dates back to 1994 when the Dietary Supplement Health and Education Act (“DSHEA”) was enacted in America. This legislation emerged after a significant public backlash against the Food and Drug Administration’s (“FDA”) proposal to regulate dietary supplements as drugs. The DSHEA ultimately categorized supplements, encompassing vitamins, minerals, and herbals, as a special category of foods. This classification subjected them to a distinct set of regulations separate from those for conventional foodstuffs and pharmaceuticals, creating a safe harbour for them, and allowing a multi-billion dollar industry to innovate, grow and create jobs.

Under DSHEA, the FDA possesses regulatory authority and enforcement tools to ensure consumer safety while maintaining access to a diverse array of affordable, high-quality dietary supplements. Unlike drugs, dietary supplements do not require pre-market approval in the USA. Instead, manufacturers must notify the FDA within 75 days of launching a new product. Moreover, they must adhere to good manufacturing practices (“GMP”), ensuring the identity, purity, quality, strength, and composition of their products. This means they are true-to-label.

Manufacturers making claims about a supplement’s effect on body structure or function, its benefits for nutrient deficiency diseases, or general well-being must substantiate these claims to ensure they are truthful and not misleading. However, the FDA does not pre-approve these claims or other labeling before the products hit the market.

Show us the Dead Bodies!

Despite the relaxed regulatory environment, dietary supplements in the USA have a strong safety record. In 2019, surveys by the American Osteopathic Association and the Council for Responsible Nutrition revealed that between 77% and 86% of Americans used natural health products regularly. This equates to an estimated 6 billion individual doses consumed annually. Remarkably, there have been no recorded deaths from acute adverse reactions to these supplements, a trend consistent over many years of meticulous data collection.

The American Association of Poison Control Centers, which represents 55 poison and adverse drug reaction reporting centers across the nation, underscores this safety record. Its “2022 Annual Report of the National Poison Data System (NPDS) from America’s Poison Centers” highlights the minimal risk associated with dietary supplements. Of the reported poisonings, only 81,610 (4.83%) involved dietary supplements, with no deaths recorded. In stark contrast, pharmaceutical drugs accounted for 1,127,203 cases (42.7%) and according to the FDA, there were approximately 106,000 deaths from adverse drug reactions just last year. The most lethal pharmacological categories of drugs included analgesics, antidepressants, antihistamines, cardiovascular drugs, sedatives, hypnotics, antipsychotics, and anticoagulants.

The USA’s regulatory approach to dietary supplements might differ from most other countries, but the data shows that these products maintain a strong safety profile despite the regulatory leniency and ease of doing business. As consumers continue to seek natural health products, this common sense regulatory framework ensures access and affordability without compromising safety.

The United States stands as a colossal market for dietary supplements, benefiting from minimal regulatory constraints. Valued at approximately USD 66.75 billion in 2023, this market is expected to grow to USD 72.69 billion by the end of 2024. With over 200 million Americans consuming more than 6 billion doses annually, the impeccable safety record, marked by zero reported deaths year-on-year, underscores the reliability and widespread acceptance of dietary supplements in the nation. This robust consumption and safety profile highlight the market’s dynamic growth and the pivotal role these supplements play in American health routines.

In South Africa, the regulatory landscape for complementary medicines is fraught with challenges. The SAHPRA has repeatedly attempted to regulate these products under the same stringent framework used for pharmaceutical medicines. This approach, often justified as protecting the public from risky products, threatens to impose prohibitive costs and inappropriate regulations on the industry. This could potentially devastate the sector, reduce the tax base, and lead to significant job losses.

But how do these complementary medicines, or dietary supplements as they’re known in the USA, actually compare in terms of safety between countries?

Legal battles, such as the cases of Alliance for Natural Health vs. Minister of Health and SAHPRA, have revealed that SAHPRA’s own pharmacovigilance database has not documented any verifiable deaths related to complementary medicines and health supplements. Since 2011, SAHPRA has included these products in their adverse drug reporting systems, which now even allow for reports via a smartphone app. Despite this, the database remains clear of any fatal incidents tied to these products.

Conversely, pharmaceutical drugs consumed in South Africa present a starkly different picture. Approximately one in twelve hospital ward admissions (8.33%) are due to adverse drug reactions, and account for 16% of deaths among adult medical admissions. Almost half of these deaths are preventable, which indicates the need for research and monitoring to inform and transform clinical practice. According to Statistics South Africa hospital admissions vary each year. As of recent available data, around 8 to 9 million hospital ward admissions occur annually in both public and private healthcare facilities.

We conservatively estimate that more than 3,700 South Africans die from severe adverse reactions to correctly prescribed medications approved by SAHPRA each year. This statistic is comparable to the catastrophic loss of life from 21 full Boeing 737 crashes, or 316 full minibus taxis, each carrying 12 passengers dying in road accidents. The issue is compounded by inadequate adverse drug reaction reporting, with many incidents likely going unreported. For instance, a study highlighted that in 2017, the completeness of adverse drug reaction reports was alarmingly low, with a mean score of only 0.456, and only 11.3% of reports achieving a score of 0.8.

A 2017 survey by Pharmadynamics found that nearly half of South African adults take at least one natural health product daily. This widespread usage is driven by a growing interest in healthy living and disease prevention. Similar to the USA, South Africa sees a high consumption of these supplements with no reported deaths, underscoring their safety. Despite these facts, SAHPRA has struggled to align its stance with the evidence, persisting with outdated justifications for stringent controls. Now, with our courts declaring the current regulations unconstitutional and unlawful, there is a clear opportunity for change. It’s time for lawmakers to establish a new regulatory framework that respects the unique nature of natural health products, ensuring their safety without imposing unnecessary burdens.

SAHPRA must prove that natural health products pose a risk to society, which they have not done effectively, even in court. They need to present robust evidence supporting their claims and justification to regulate natural health products as medicines. It is unacceptable for us to prove these products are safe when the burden of proof lies with them. If SAHPRA claims regulations are necessary under the Medicines Act due to risks, they must justify this with current and solid evidence. Too often, SAHPRA shifts this burden of proof to us, where it doesn’t belong.

Why natural health products should be regulated as a special category of foods, than drugs:

FOOD SUPPLEMENTS

1. Intended Use: Food supplements are generally intended to supplement the diet and provide nutrients that may be missing, rather than treat or cure diseases.
2. Safety Profile: Most food supplements have a long history of safe use at recommended doses, similar to foods.
3. Consumer Access: Classifying food supplements as foods allows for greater consumer access and choice, without the stringent requirements that apply to pharmaceutical medicines.
4. Regulatory Burden: Regulating food supplements as pharmaceutical medicines would impose a significant regulatory burden on manufacturers, leading to increased costs and potentially reduced availability.
5. Market Dynamics: The food supplement market is large and diverse; treating supplements as pharmaceutical medicines could stifle innovation and limit the variety of products available to consumers.
6. Nutrient Supplementation: Many food supplements provide essential nutrients that are necessary for maintaining health, similar to fortified foods.
7. Historical Precedent: Food supplements have historically been regulated as foods in many jurisdictions, with systems in place to ensure safety and quality.
8. Risk Level: The risk profile of food supplements is far lower than that of pharmaceutical medicines, justifying a different regulatory approach.
9. Consumer Understanding: Consumers typically understand food supplements as part of their diet, not as medicinal products.
10. Labeling Practices: Food supplement labels already provide information similar to food labels, such as nutrient content and daily values, aiding consumer understanding.
11. Cultural Practices: In many cultures, traditional and herbal supplements are part of the dietary landscape, not the medical one.
12. Scientific Basis: The scientific basis for many food supplements is similar to that for foods, focusing on nutritional and health benefits rather than disease treatment.
13. Quality Standards: Existing food regulations can be adapted to ensure the quality and safety of food supplements without the need for pharmaceutical medicine-level scrutiny.
14. Cost Implications: Regulating food supplements as pharmaceutical medicines will significantly increase costs for manufacturers and consumers, making these products less accessible.
15. Health Promotion: Food supplements play a role in health promotion and disease prevention, aligning them more closely with foods.
16. Consumer Trust: Consumers often trust food supplements as part of their diet and may view a pharmaceutical medicines classification as overly restrictive or unnecessary.
17. Regulatory Framework: Existing food safety frameworks can be effectively used to regulate food supplements, ensuring safety without the complexity of pharmaceutical medicine regulation.
18. Industry Structure: The food supplement industry is structured around food production and marketing practices, not pharmaceutical medicines ones.
19. Innovation Encouragement: Treating food supplements as foods encourages ongoing innovation in the sector, leading to new and improved products that benefit consumers.

These reasons highlight the unique position of dietary supplements in the marketplace and support the argument for regulating them as foods rather than drugs.

HERBAL INGREDIENTS

Whether herbal ingredients should be regulated as food supplements depends on several factors, including their intended use, safety profile, and the regulatory framework of the country in question. Here are some key points supporting the regulation of herbal ingredients as food supplements:

1. Historical and Traditional Use: Many herbal ingredients have a long history of traditional use as part of the diet in various cultures, often consumed as teas, extracts, or food additives. This traditional usage aligns more closely with food than with pharmaceutical medicines.
2. Safety Profile: Most herbal supplements, when used appropriately, have a safety profile that is more similar to foods than to pharmaceutical medicine. They are generally used to support health and wellness rather than to treat or cure diseases, which is a primary criterion for classifying them as food supplements.
3. Consumer Expectations and Access: Consumers often use herbal supplements as part of their daily diet to enhance overall well-being or to address minor health concerns. Regulating these products as food supplements ensures easier access and aligns with consumer expectations.
4. Regulatory Framework: Existing food safety regulations can be adapted, or new regulations can be gazetted to ensure the quality, safety, and labeling of herbal supplements. This framework can effectively manage potential risks without the need for the stringent requirements that apply to pharmaceutical medicines.
5. Nutritional and Health Benefits: Many herbal ingredients provide nutritional benefits or support physiological functions in ways similar to other food supplements, such as vitamins and minerals. This further supports their classification as food supplements​.
6. International Standards: In many countries, herbal supplements are already regulated as food supplements. For example, in the United States, the Dietary Supplement Health and Education Act (DSHEA) of 1994 categorizes dietary supplements, including herbal products, as a special category of foods, not drugs.
7. Labeling and Claims: Regulating herbal ingredients as food supplements allows for appropriate labeling and health claims that inform consumers about their benefits and safe usage without implying that they are intended to treat or cure diseases.

However, it’s important to consider potential risks and ensure appropriate regulations are in place to protect consumers. This includes:

• Quality Control: Ensuring that herbal supplements are free from contaminants and are manufactured according to good manufacturing practices (GMP).
• Safety Monitoring: Implementing robust post-market surveillance to monitor adverse effects and ensure ongoing safety.
• Clear Labeling: Providing accurate and clear labeling to inform consumers about the contents, usage, and any potential risks associated with the herbal supplement.

In conclusion, regulating herbal ingredients as food supplements is generally appropriate given their traditional use, safety profile, and the need for consumer access. However, appropriate quality control, safety monitoring, and clear labeling are essential to ensure consumer safety and informed use.