The question of why they stopped making contact medicine with its original, effective formula is rooted in two significant historical events: a product tampering scare in the 1980s and a major public health advisory related to the ingredient phenylpropanolamine (PPA) in 2000. The latter was the definitive reason for the permanent removal of the original formulation from the market.
The Product Tampering Incident of the 1980s
Before the final discontinuation of the original formula, the manufacturer of Contac faced a serious challenge involving product safety and public trust. In the mid-1980s, after the notorious Tylenol cyanide poisonings, tampering with over-the-counter capsules became a widespread fear.
Contac's 1986 Recall
In March 1986, Contac was temporarily recalled from store shelves after traces of rat poison were found in capsules in Texas and Florida. While there were no confirmed deaths from this specific incident, the scare led the manufacturer, SmithKline Beckman, to take immediate action. The incident resulted in:
- A nationwide recall of the product.
- An $8 million financial loss for the company.
- The temporary suspension of capsule products, with the company opting to relaunch the product in tamper-resistant caplets and gelatin-sealed capsules.
This incident demonstrated a vulnerability in capsule-based medications and accelerated the pharmaceutical industry's adoption of more secure packaging. However, this was a temporary measure. The final nail in the coffin for the original Contac formula would come more than a decade later.
The Permanent Removal: Phenylpropanolamine and Hemorrhagic Strokes
The ingredient phenylpropanolamine (PPA) was a common decongestant and appetite suppressant used in many over-the-counter products, including the original Contac. Its removal in 2000 was a direct result of mounting evidence linking it to a serious health risk.
The Hemorrhagic Stroke Project
In the late 1990s, a study known as the Hemorrhagic Stroke Project, conducted by scientists at Yale University, investigated the link between PPA and hemorrhagic stroke (bleeding in the brain). The study's findings, published in 2000, were alarming:
- Women aged 18 to 49 who used PPA-containing appetite suppressants were found to have a significantly increased risk of hemorrhagic stroke.
- While the absolute risk was low, the severity of the potential adverse event (irreversible and often deadly stroke) was deemed too great for a product sold over-the-counter.
- The risk was also noted in first-time users of cough and cold remedies containing PPA.
FDA Action and Regulatory Changes
Acting on the recommendations of its Nonprescription Drug Advisory Committee (NDAC), the FDA took swift and decisive action in November 2000. The agency requested that all drug manufacturers voluntarily stop marketing products containing PPA and find safer alternatives. In 2014, the FDA officially withdrew approval for PPA in new drug applications and removed its "generally recognized as safe and effective" (GRASE) status for over-the-counter use, effectively banning it from being sold in the United States.
What Happened Next: Reformulation and Replacement
Following the PPA recall, manufacturers scrambled to reformulate their products. This ushered in a new era of OTC decongestants, with a complicated history of their own.
The Alternatives
- Pseudoephedrine: Many manufacturers initially turned to pseudoephedrine as a replacement for PPA. It is also a potent decongestant, but its sale was later restricted due to its use in the illegal manufacture of methamphetamine. In the US, products containing pseudoephedrine are now sold behind the pharmacy counter.
- Oral Phenylephrine: For easier access, most OTC decongestants available on store shelves without a prescription switched to oral phenylephrine. However, a 2023 FDA advisory committee unanimously concluded that oral phenylephrine is not effective as a nasal decongestant, casting doubt on the efficacy of a large segment of the modern OTC cold medicine market.
PPA vs. Modern Decongestants
The transition from PPA to modern alternatives was driven by safety concerns and has resulted in a shift in the perceived efficacy and accessibility of decongestants.
| Feature | Original PPA-containing Contac | Modern OTC Oral Decongestants (e.g., phenylephrine) | Behind-the-Counter Pseudoephedrine |
|---|---|---|---|
| Primary Decongestant | Phenylpropanolamine (PPA) | Phenylephrine | Pseudoephedrine |
| Market Status | Removed in 2000 | Available over-the-counter | Available behind the pharmacy counter |
| Safety Concerns | Increased risk of hemorrhagic stroke in some users, especially young women | None comparable to PPA; primary concern is lack of efficacy in oral form | Known to increase heart rate and blood pressure; higher potential for abuse |
| Regulatory Action | Banned by FDA | Considered ineffective by 2023 FDA advisory panel; potential removal from OTC status | Restricted for sale under the Combat Methamphetamine Epidemic Act of 2005 |
| Ease of Purchase | Once easily available over-the-counter | Easily available on store shelves | Requires a pharmacist and ID to purchase |
Other Affected Medications
The PPA recall did not only impact Contact medicine. Numerous other popular cold and diet products containing the ingredient were also affected. Some of the well-known brands that were reformulated or discontinued include:
- Dimetapp
- Triaminic
- Acutrim
- Dexatrim
- Comtrex
- Robitussin CF
- Naldecon
Conclusion
The definitive reason why they stopped making contact medicine with its original formula was the 2000 FDA advisory linking the decongestant PPA to an increased risk of hemorrhagic stroke. This decision, made in the interest of public safety, led to the withdrawal of PPA from the market and the subsequent reformulation of countless cold and diet drugs. While the original Contac's journey was also marked by an earlier tampering incident, the PPA ban permanently altered the landscape of over-the-counter cold remedies. Today, consumers have access to reformulated products, though the evolution of decongestant pharmacology continues to face new challenges, such as the debate over oral phenylephrine's efficacy.
