FDA has announced $5.1 billion budget for FY 2017, which would include the funds for implementation of New Food Safety System, Improving safety and quality of medical products and FDA’s infrastructure improvement and supporting cancer moonshot initiative. The agency is responsible for dietary food supplements, cosmetic products and other genera of products. This budget will implement from October 1, 2016. This is good news for FDA’s enforced actions and power extensions against innovative food products and supplements becoming a cause of health threat.
US Marshals, at FDA’s request, seized dietary supplements containing ‘Kratom’ (Botanical name: Mitragyna speciosa); as FDA considers it as a health risk. Melinda Plaisier, the FDA’s asso. Commissioner for regulatory affairs, viewed that Kratom could be a public health risk and had a potential for abuse. So FDA, while exercising its full authority of law, took action against this newly made dietary supplement and detained ‘Relakzpro’ under FD&C Act. The agency can keep the detained product away from marketplace for maximum 30 days. In December 2015 the five trade unions representing the dietary supplements welcomed upgrading of FDA’s department Division of Dietary Supplement program (DDSP) to a status of ‘office’. They believed that it would enhance the effectiveness of dietary supplement regulations and could increase FDA’s abilities to take more aggressive enforcement action.
Here a complete analysis has been done to chalk out the adversaries caused by dietary supplements to public health.
The Dietary Supplement Health and Education Act of 1994 characterize herbal (botanical) products, complementary nutritionals such as amino acids and micronutrients (minerals and vitamins) as dietary supplements. Although these supplements cannot be marketed with the intent for treating and preventing diseases, they are generally taken to minimize or manage the symptoms of various illnesses, as well as to improve or maintain overall health status.
There has been a sharp rise in the number of dietary supplements; 4,000 in 1994 to above 55,000 in 2012. It was reported in 2007 that personal expenditures for herbal or complementary supplements was $14.8 billion, one third of the personal expenditures for prescription drugs.
Fatal Dietary Supplements: Questioning Safety Of Dietary Supplements
The Food and Drug Administration (FDA) is responsible for overseeing all dietary supplements, and if such a product is found to be unsafe, the FDA can order the manufacturer to recall the product from the market. However, these regulatory protocols differ slightly for prescription and over-the-counter drugs. Manufacturers producing dietary supplements that contain ingredients introduced after October 15, 1994 are obligated to notify the FDA before marketing them, and are also required to provide a rationale outlining the safety of those ingredients. Nevertheless, no such safety testing or FDA approval is required before marketing dietary supplements.
Post-marketing regulatory protocols for the removal of adulterated supplements form the market has received substantial attention. Between 2004 and 2012, over 200 dietary supplements containing unapproved ingredients or impurities were recalled, and steps to remove the lapses in preparation were pursued. Moreover, manufacturers are required to report any post-marketing adverse reactions to dietary supplements only in the case of serious events, such as those resulting in hospitalization, disability or death. Voluntary reporting of any such incident significantly underestimates their occurrence and intensity.
Another troubling aspect is that the safety of unadulterated dietary supplements and the extent of their adverse effects are also not well documented. This analysis looks into nationally representative surveillance data to evaluate visits to the emergency department in relation to adverse events due to dietary supplements. Moreover, the idea is to identify similar features among patients, products and the types of events.
A study carried by Dr Andrew I Geller, MD and his team to determine the adverse effects of dietary supplements during emergency departments of various hospitals and was published in The New England Journal of Medicine.
Collecting Various Forms Of Data For Analysis
During the study following sources were used to obtain data relevant to the analysis:
- Division of Healthcare Quality Promotion
- Centers for Disease Control and Prevention (AIG, NS, MCL, DSB)
- Chenega Government Consulting (NJW) — both in Atlanta
- Center for Food Safety and Applied Nutrition
- Division of Public Health Informatics and Analytics (BJW, BBT)
- Division of Dietary Supplement Programs (RPM)
- Food and Drug Administration, College Park, MD.
Data regarding the number of emergency department visits in the US, related to adverse events caused by dietary supplements, was recorded from January 1, 2004 to December 31, 2013. A nationally representative sample was drawn from 63 hospitals with approximately six beds and a 24-hour emergency department. These hospitals were also a part of the National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance (NEISS-CADES) project conducted by the Centers for Disease Control and Prevention (CDC), the FDA, and the Consumer Product Safety Commission.
Trained personnel at each hospital reviewed clinical records of the emergency visits to identify those that were reported as ‘physician-diagnosed adverse events related to dietary supplements (at least two implicated products and 10 associated products). The personnel also took narrative accounts of the events, such as the preceding situation, diagnosis and testing, administered treatment in the emergency department or by emergency services, and prognosis.
Defining Inclusion Criteria And Adverse Effects
Potential cases were defined as those emergency visits that were linked to problems treated specifically for events related to dietary supplements. This included orally administered herbal or complementary nutritional products (botanicals, microbial additives, and amino acids), micronutrients (vitamins and minerals) and topically administered herbal or homeopathic products, and excluded products typically considered to be foods or drinks (energy drinks, herbal tea beverages, etc).
Adverse events were categorized as allergic reactions, excessive doses, unsupervised ingestion by children, or other events (such as choking). Cases involving deaths on the way to the emergency department were excluded, since the record of such information varied among hospitals. Cases of intentional self-harm, therapeutic failure, drug abuse, withdrawal or non-adherence were also excluded. Symptoms were categorized based on MedDRA-coded narratives.
The Consumer Product Safety Commission analyzed cases based on inverse probability of selection after adjustment for nonresponse and hospital nonparticipation, as well as accounting for changes in the number of annual US emergency department visits. Implicated products and symptoms were restricted to cases involving a single dietary supplement. Unsupervised ingestions by children were separately analyzed.
Deciphering Each Result Individually
· Supplement-Related Emergency Department Visits
With respect to the 3,667 cases identified between 2004 and 2013, an average of 23,005 annual emergency visits attributed to dietary supplements was calculated, more than half of which were females. Further analysis revealed that about 88.3 percent of these visits would lead to hospitalization every year, most of which were associated with a single supplement rather than multiple usages.
· According To Products
The most common product for unsupervised ingestion of dietary supplements by children was seen to involve a micronutrient, most specifically products that included multivitamins, iron, and supplements for weight loss, sleep, anxiolysis and sedation.
Apart from cases of unsupervised ingestion by children, 65.9 percent of emergency visits involved herbal or complementary nutritional supplement; 31.8 percent included a product featuring a single micronutrient, 25.5 percent involved a weight-loss product and 10.0 percent involved an energy product.
· According To Gender
Female patients were involved in 3,399 cases (30.4 percent) of ingestion of weight-loss products, approximately thrice the number of male patients (17.6 percent) registered for a similar adverse event. Products for sexual enhancement or bodybuilding were accounted for 14.1 percent of emergency visits of male patients, as compared to the insignificant number of similar cases for females.
· According To Age
After excluding cases of unsupervised ingestion by children, micronutrients were responsible for two-thirds of emergency visits among children aged four or younger (67.3 percent) and adults aged 65 or above (62.7 percent). Herbal or complementary nutritional products were the most common culprits in other age groups.
Weight loss products or energy products were responsible for more than half of emergency visits among patients between the ages of five and 19 as well as between 20 and 34 years of National Estimates of Emergency Department Visits for Adverse Events Associated with Dietary Supplements, according to Age Group and Product Category (2004–2013). For adults aged 65 and older the most common micronutrient ingestion was of iron, calcium and potassium, accounting for almost one-third of all emergency visits.
· Most Common Adverse Symptoms
The most commonly reported symptoms associated with the use of weight-loss products and energy products were cardiac in nature (palpitations, tachycardia, chest pain); these involved 71.8 percent of all emergency visits. Most of the patients with these complaints were between the ages of 20 and 34. Similar cardiac adversities were also seen as a result of bodybuilding and sexual enhancement products. However, most of these patients were discharged from the department after check-up.
Frequently seen adverse effects from micronutrient usage (apart from iron, sodium and potassium) included mild to moderate allergic reactions and swallowing difficulties (choking and pill-induced dysphagia or globus). Calcium products usually resulted in emergency visits involving swallowing problems, and potassium or iron products caused gastrointestinal symptoms such as nausea and vomiting.
Supplement-induced swallowing problems were not commonly seen among patients between the ages of six and 64, but were more common among older patients; 83.1 percent of all cases for such products were swallowing problems associated with micronutrients.
· Trends Over Time
A significant increase was recorded in the annual adverse events related to micronutrients (except iron, calcium and potassium) – 3,212 in 2004–2005 to 4,578 in 2012–2013.
Limitations Of Findings
Certain limitations of the analysis should also be noted:
- The number of visits attributed to supplement-related adverse events might be an underestimation, since they are often underreported or misunderstood by patients and physicians.
- A proper understanding of drug and dietary supplement interactions is generally limited.
- Products typically considered to be foods or drinks (energy drinks, herbal tea beverages, etc) were excluded from the analysis.
- Small sample size and limited study design might influence the results.
- A restricted regulatory framework makes it challenging to efficiently monitor the safety of supplements. Also, the adverse events related to a specific ingredient, product or type could not be calculated due to limited quantification.
- Characterization of supplements was done on the basis of common reasons for usage – this might have been more specified.
Discussion And Analysis
On the basis of this nationally representative sample of emergency department visits between 2004 and 2013, it can be fairly estimated that dietary supplements were responsible for an average of 23,000 emergency visits, along with 2000 hospitalizations every year. Most of the visits were associated with cardiovascular events from energy, herbal or weight-loss products especially among young adults. Complaints about children involved unsupervised ingestion of micronutrients, and adversities concerning older adults were associated with swallowing problems. This is sufficient evidence to suggest that these products are being marketed without proper regulation and safety protocols.
Based On These Findings, The Following Recommendations Can Be Made
- Clinicians and physicians must be encouraged to educate patients about the uses and potential adverse effects of dietary supplements.
- Apart from medical professionals, a wider campaign must be launched to educate the public about the correct usage, requirements, dosage and side-effects of dietary supplements.
- Child-resistant and innovative safety packaging must be included in the protocol for manufacturing and marketing all types of dietary supplements to prevent cases of unsupervised ingestion.
- Targeted education of the safe storage of these products can also play a significant role in protecting these products from children.
- For reducing cases of swallowing problems among older adults, the FDA suggests limiting the size of pharmaceutical tablets to 22mm. Moreover, tablet size and shape must be reported on abbreviated new-drug applications. A similar approach must be followed for dietary supplements.
- Other forms of delivery, such as liquids, powders or gels, especially for micronutrients, must be considered for older adults. They should also be educated about the proper method of swallowing pills to avoid potential problems, and must also be taught how to deal with the latter.
Targeted interventions are required to help reduce the risk and adverse events associated with using dietary supplements without proper consultation with a medical professional. The CDC and FDA must be alerted with the findings of such an analysis so that respective measures can begin immediately.